{ "FullStudy":{ "Rank":218225, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01511107", "OrgStudyIdInfo":{ "OrgStudyId":"10-0083" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"AI2009058", "SecondaryIdType":"Other Identifier", "SecondaryIdDomain":"NIH NIAID" } ] }, "Organization":{ "OrgFullName":"University of Pittsburgh", "OrgClass":"OTHER" }, "BriefTitle":"Efficacy of Short-Course Antimicrobial Treatment for Children With Acute Otitis Media and Impact on Resistance", "OfficialTitle":"A Phase 2b, Multicenter, Randomized, Double Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy of Short-Course Antimicrobial Therapy for Young Children With Acute Otitis Media (AOM) and Impact on Antimicrobial Resistance" }, "StatusModule":{ "StatusVerifiedDate":"October 2017", "OverallStatus":"Terminated", "WhyStopped":"The primary objective of the study was met.", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"September 2015", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"October 2015", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 10, 2012", "StudyFirstSubmitQCDate":"January 13, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 18, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"September 30, 2016", "ResultsFirstSubmitQCDate":"December 19, 2016", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"February 10, 2017", "ResultsFirstPostDateType":"Actual" }, "LastUpdateSubmitDate":"October 5, 2017", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"October 6, 2017", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor-Investigator", "ResponsiblePartyInvestigatorFullName":"Alejandro Hoberman", "ResponsiblePartyInvestigatorTitle":"Professor of Pediatrics", "ResponsiblePartyInvestigatorAffiliation":"University of Pittsburgh" }, "LeadSponsor":{ "LeadSponsorName":"Alejandro Hoberman", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"National Institute of Allergy and Infectious Diseases (NIAID)", "CollaboratorClass":"NIH" } ] } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"The investigators will study whether, in young children with acute otitis media (AOM), shortening length of antibiotic treatment as a strategy for reducing antimicrobial resistance provides satisfactory clinical outcome. This is a Phase 2b multicenter, randomized, double-blind, placebo-controlled clinical trial in 600 children aged 6 through 23 months comparing the efficacy of consistent reduced-duration antimicrobial treatment (5 days) with that of consistent standard-duration treatment (10 days) for each episode of AOM developing during a single respiratory season (October 1 through May 31).", "DetailedDescription":"Eligible subjects will be randomized at the enrollment visit and will have a telephone call in the course of therapy, and a subsequent visit at the end of therapy. Thereafter, they will be followed through the end of the respiratory season, and their parents will be encouraged to bring their child when concerned about a potential recurrence of AOM. At each recurrence subjects will receive the treatment regimen (either standard- or reduced-duration) to which they were randomized at study entry (consistent treatment strategy).\n\nThe recruitment of eligible children with AOM of varying degrees of severity from various primary care practices in 2 separate geographic regions, i.e. Western Pennsylvania and Kentucky, representing urban, suburban and rural demographics will enhance generalizability of study findings and encourage translation to clinical practice." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Acute Otitis Media" ] }, "KeywordList":{ "Keyword":[ "acute otitis media", "ear infection", "antimicrobial therapy", "antimicrobial resistance" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 2" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Quadruple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider", "Investigator", "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"520", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Amoxicillin-Clavulanate, 10 days", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"amoxicillin-clavulanate, 90/6.4 mg/kg/day, 2 divided doses, 10 days", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Amoxicillin-Clavulanate, 10 days" ] } },{ "ArmGroupLabel":"Amoxicillin-Clavulanate, 5 days", "ArmGroupType":"Other", "ArmGroupDescription":"amoxicillin-clavulanate, 90/6.4 mg/kg/day, 2 divided doses, 5 days plus placebo, 2 divided doses, 5 days", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Amoxicillin-Clavulanate, 5 days" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Amoxicillin-Clavulanate, 10 days", "InterventionDescription":"Amoxicillin-clavulanate (90/6.4mg/kg/day in 2 divided doses) Days 1-10", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Amoxicillin-Clavulanate, 10 days" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "augmentin", "amox-clav" ] } },{ "InterventionType":"Drug", "InterventionName":"Amoxicillin-Clavulanate, 5 days", "InterventionDescription":"Amoxicillin-clavulanate (90/6.4mg/kg/day in 2 divided doses) Days 1-5\n\nPlus\n\nPlacebo Days 6-10", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Amoxicillin-Clavulanate, 5 days" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "augmentin", "amox-clav" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"The Distribution of Children Categorized as Treatment Failure (TF) at or Before the Day 12-14 End-of-Treatment Visit Specific to the Index Episode of AOM", "PrimaryOutcomeDescription":"Proportion of children initially diagnosed with AOM who experience treatment failure at or before the day 12-14 visit.\n\nTF is defined as substantial persistence or worsening of symptoms specifically attributable to AOM, or of otoscopic signs of AOM, after 72 hours from the time of randomization, such that additional antimicrobial therapy is deemed advisable. If a parent/legal guardian is unwilling to continue the assigned study product regimen, the participant will be categorized as TF. Should a participant be administered another systemic antibiotic while taking study medication or prior to Day 16, the participant will be considered a TF. Clinical success is defined as complete or substantial resolution of symptoms specifically attributable to AOM for 48 hours and of otoscopic signs of acute inflammation (bulging of the tympanic membrane (TM) or intense erythema), with or without persistence of middle-ear effusion, such that no additional antibiotic therapy is deemed advisable.", "PrimaryOutcomeTimeFrame":"From 72 hours after randomization until day 21 of the index episode. The mean day for this visit was 13.2." } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"The Distribution of AOM Recurrences Categorized as Treatment Failure (TF) at or Before the Day 12-14 End-of-Treatment Visit", "SecondaryOutcomeDescription":"Proportion of AOM recurrences resulting in treatment failure at or before the day 12-14 visit.\n\nTF is defined as substantial persistence or worsening of symptoms specifically attributable to AOM, or of otoscopic signs of AOM, after 72 hours from the time of the recurrence, such that additional antimicrobial therapy is deemed advisable. If a parent/legal guardian is unwilling to continue the assigned study product regimen, the participant will be categorized as TF. Should a participant be administered another systemic antibiotic while taking study medication or prior to Day 16, the participant will be considered a TF. Clinical success is defined as complete or substantial resolution of symptoms specifically attributable to AOM for 48 hours and of otoscopic signs of acute inflammation (bulging of the TM or intense erythema), with or without persistence of middle-ear effusion, such that no additional antibiotic therapy is deemed advisable.", "SecondaryOutcomeTimeFrame":"From 72 hours after the AOM recurrence was diagnosed until day 21 of the recurrence. The mean day for this visit was 13.3." },{ "SecondaryOutcomeMeasure":"The Distribution of Children With a Nasopharyngeal (NP) Culture at Enrollment That is Negative for AOM Pathogens in Which the Follow-up NP Culture at Day 12-14 Yields a Nonsusceptible Pathogen", "SecondaryOutcomeDescription":"AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.", "SecondaryOutcomeTimeFrame":"The day 12-14 visit. The mean day for this visit was 13.3." },{ "SecondaryOutcomeMeasure":"The Distribution of AOM Recurrences With a Nasopharyngeal (NP) Culture at Onset That is Negative for AOM Pathogens in Which the Follow-up NP Culture at Day 12-14 Yields a Nonsusceptible Pathogen", "SecondaryOutcomeDescription":"AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.", "SecondaryOutcomeTimeFrame":"The day 12-14 visit. The mean day for this visit was 13.4." },{ "SecondaryOutcomeMeasure":"The Distribution of Children With a Nasopharyngeal (NP) Culture at Enrollment That is Positive Only for One or More Susceptible Pathogens in Which the Follow-up NP Culture at Day 12-14 Yields a Nonsusceptible Pathogen", "SecondaryOutcomeDescription":"AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.", "SecondaryOutcomeTimeFrame":"The day 12-14 visit. The mean day for this visit was 13.2." },{ "SecondaryOutcomeMeasure":"The Distribution of AOM Recurrences With a Nasopharyngeal (NP) Culture at Onset That is Positive Only for One or More Susceptible Pathogens in Which the Follow-up NP Culture at Day 12-14 Yields a Nonsusceptible Pathogen", "SecondaryOutcomeDescription":"AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.", "SecondaryOutcomeTimeFrame":"The day 12-14 visit. The mean day for this visit was 13.9." },{ "SecondaryOutcomeMeasure":"The Distribution of Children With a Nasopharyngeal (NP) Culture at Enrollment That is Positive for One or More Nonsusceptible Pathogens in Which the Follow-up NP Culture at Day 12-14 Yields a Nonsusceptible Pathogen", "SecondaryOutcomeDescription":"AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.", "SecondaryOutcomeTimeFrame":"The end-of-treatment visit. The mean day for this visit was 13.6." },{ "SecondaryOutcomeMeasure":"The Distribution of AOM Recurrences With a Nasopharyngeal (NP) Culture at Onset That is Positive for One or More Nonsusceptible Pathogens in Which the Follow-up NP Culture at Day 12-14 Yields a Nonsusceptible Pathogen", "SecondaryOutcomeDescription":"AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.", "SecondaryOutcomeTimeFrame":"The end-of-treatment visit. The mean day for this visit was 13.4." },{ "SecondaryOutcomeMeasure":"The Distribution of Children Whose Nasopharyngeal (NP) Isolates at Enrollment Are Pathogen Negative or Positive Only for at Least One Susceptible Pathogen Who Become Colonized With Nonsusceptible Pathogens at Any Time Over the Course of Follow-up", "SecondaryOutcomeDescription":"AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.", "SecondaryOutcomeTimeFrame":"Day 1 of study entry until day 365" },{ "SecondaryOutcomeMeasure":"The Distribution of 6 Week Follow-up, Non-Illness Visits During the Respiratory Season at Which a Nonsusceptible Pathogen is Recovered", "SecondaryOutcomeDescription":"AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.", "SecondaryOutcomeTimeFrame":"Day 1 of study entry until day 244. The respiratory season is October 1 - May 31, inclusive." },{ "SecondaryOutcomeMeasure":"The Distribution of Children for Whom the Follow-up Nasopharyngeal (NP) Culture at the Day 12-14 Visit, Specific to the Index Episode, Yields a Nonsusceptible Streptococcus Pneumoniae (S pn) Isolate", "SecondaryOutcomeDescription":"In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm.", "SecondaryOutcomeTimeFrame":"The day 12-14 visit specific to the index episode. The mean day for this visit was 13.4." },{ "SecondaryOutcomeMeasure":"The Distribution of AOM Recurrences for Which the Follow-up Nasopharyngeal (NP) Culture at the Day 12-14 Visit Yields a Nonsusceptible Streptococcus Pneumoniae (S pn) Isolate", "SecondaryOutcomeDescription":"In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm.", "SecondaryOutcomeTimeFrame":"The day 12-14 visit following a recurrence. The mean day for this visit was 13.6." },{ "SecondaryOutcomeMeasure":"The Distribution of Children for Whom the Follow-up Nasopharyngeal (NP) Culture at the Day 12-14 Visit, Specific to the Index Episode, Yields a Nonsusceptible Haemophilus Influenzae (H Flu) Isolate", "SecondaryOutcomeDescription":"In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.", "SecondaryOutcomeTimeFrame":"The day 12-14 visit specific to the index episode. The mean day for this visit was 13.4." },{ "SecondaryOutcomeMeasure":"The Distribution of AOM Recurrences for Which the Follow-up Nasopharyngeal (NP) Culture at the Day 12-14 Visit Yields a Nonsusceptible Haemophilus Influenzae (H Flu) Isolate", "SecondaryOutcomeDescription":"In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.", "SecondaryOutcomeTimeFrame":"The day 12-14 visit following a recurrence. The mean day for this visit was 13.6." },{ "SecondaryOutcomeMeasure":"The Distribution of Children With AOM Recurrences and Relapses Within 60 Days of Enrollment", "SecondaryOutcomeDescription":"An episode of AOM occurring after Day 16 will be considered a recurrence. Subjects seen after day 10 and categorized as clinical success who return for an interim/sick visit before day 17 and are found to have AOM will be categorized as a relapse. For secondary outcome analyses, relapses are combined with recurrences.", "SecondaryOutcomeTimeFrame":"Day 1 of study entry until day 60." },{ "SecondaryOutcomeMeasure":"The Distribution of Children With AOM Recurrences and Relapses Within the Entire Respiratory Season", "SecondaryOutcomeDescription":"An episode of AOM occurring after Day 16 will be considered a recurrence. Subjects seen after day 10 and categorized as clinical success who return for an interim/sick visit before day 17 and are found to have AOM will be categorized as a relapse. For secondary outcome analyses, relapses are combined with recurrences.", "SecondaryOutcomeTimeFrame":"Day 1 of study entry until day 244. The respiratory season is October 1 - May 31, inclusive." },{ "SecondaryOutcomeMeasure":"The Mean Rate, Per Month, of Protocol AOM Recurrences and Relapses Within 60 Days of Enrollment", "SecondaryOutcomeDescription":"An episode of AOM occurring after Day 16 will be considered a recurrence. Subjects seen after day 10 and categorized as clinical success who return for an interim/sick visit before day 17 and are found to have AOM will be categorized as a relapse. For secondary outcome analyses, relapses are combined with recurrences.\n\nThe rate, expressed as a monthly rate, is calculated by dividing the total number of recurrences and relapses within 60 days of enrollment by the number of months of follow-up within 60 days of enrollment.", "SecondaryOutcomeTimeFrame":"Day 1 of study entry until day 60." },{ "SecondaryOutcomeMeasure":"The Mean Rate, Per Month, of Protocol AOM Recurrences and Relapses Within the Entire Respiratory Season", "SecondaryOutcomeDescription":"An episode of AOM occurring after Day 16 will be considered a recurrence. Subjects seen after day 10 and categorized as clinical success who return for an interim/sick visit before day 17 and are found to have AOM will be categorized as a relapse. For secondary outcome analyses, relapses are combined with recurrences.\n\nThe rate, expressed as a monthly rate, is calculated by dividing the total number of recurrences and relapses by the number of months of follow-up.", "SecondaryOutcomeTimeFrame":"Day 1 of study entry until day 244. The respiratory season is October 1 - May 31, inclusive." },{ "SecondaryOutcomeMeasure":"The Mean Number of Days Systemic Antibiotics Were Received During the Entire Respiratory Season", "SecondaryOutcomeDescription":"Systemic antibiotics include the study product, Amoxicillin-Clavulanate, dispensed for either 10 or 5 days and various concomitant medications, i.e. Amoxicillin, Amox/Clav, Azithromycin, Cefdinir, Cefpodoxime, Ceftriaxone, Erythromycin, Trimethoprim-Sulfamethoxazole, Omnicef, Augmentin, Azithromycin, Cefazolin, Clarythromycin and Ciprofloxacin.", "SecondaryOutcomeTimeFrame":"Day 1 of study entry until day 244. The respiratory season is October 1 - May 31, inclusive." },{ "SecondaryOutcomeMeasure":"The Mean Acute Otitis Media - Severity of Symptom (AOM-SOS) Scores Days 6 to 14", "SecondaryOutcomeDescription":"The AOM-SOS scale measures seven discrete items: tugging of ears, crying, irritability, difficulty sleeping, diminished activity, diminished appetite, and fever. The parent rated each of these symptoms in comparison with the child's usual state, as \"none,\" \"a little,\" or \"a lot,\" with corresponding scores of 0, 1, and 2, and recorded the ratings in a diary. Each set of ratings was summed to obtain an AOM-SOS score as a measure of symptom burden. Total scores range from 0 to 14, with higher scores indicating greater severity of symptoms. For instances in which the participant was declared a treatment failure, scores are included up to, but not including the day of the failure. Otherwise, scores day 6 to day 14 are included.", "SecondaryOutcomeTimeFrame":"From day 6 of administration of study product until day 14 for all episodes" },{ "SecondaryOutcomeMeasure":"The Distribution of Children for Whom Protocol-Defined Diarrhea (PDD) Was Reported and Associated With Study Product", "SecondaryOutcomeDescription":"Protocol-defined diarrhea is defined as the occurrence of three or more watery stools in 1 day or two watery stools daily for 2 consecutive days and is limited to events associated with study product.", "SecondaryOutcomeTimeFrame":"Day 1 of administration of study product until day 16 for all episodes" },{ "SecondaryOutcomeMeasure":"The Distribution of Children for Whom Diaper Dermatitis Was Reported and Associated With Study Product", "SecondaryOutcomeDescription":"Diaper dermatitis is defined as dermatitis in the diaper area calling for prescription of a topical antifungal agent and is limited to events associated with study product.", "SecondaryOutcomeTimeFrame":"Day 1 of administration of study product until day 16 for all episodes" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nAged 6 through 23 months\n\nHave evidence of AOM defined as:\n\nrecent (within 48 hours) onset of signs and symptoms as described in the Acute Otitis Media - Severity of Symptoms (AOM-SOS) Scale AND a score of ≥3 at the time of enrollment on the AOM-SOS scale\nmiddle ear effusion evidenced by the presence of at least 2 of the following:\ndecreased or absent mobility of the tympanic membrane\nyellow or white discoloration of the tympanic membrane\nopacification of the tympanic membrane\n\nAND\n\nacute inflammation evidenced by one of the following:\n1+ bulging of the tympanic membrane with either intense erythema or otalgia\n2+ or 3+ bulging of the tympanic membrane\nHas received at least 2 doses of pneumococcal conjugate vaccine\nParent has provided informed consent\n\nExclusion Criteria:\n\nToxic appearance [capillary refill >3 seconds, systolic blood pressure <60 mm Hg];\nInpatient hospitalization\nClinical or anatomical characteristics that might obscure response to treatment (tympanostomy tubes in place, cleft palate, or Down syndrome)\nSensorineural hearing loss (unilateral or bilateral)\nSerious underlying systemic problems that might obscure response to infection (cystic fibrosis, neoplasm, juvenile diabetes)\nConcomitant infection that would preclude evaluation of the response of the child's AOM to study product (pneumonia, periorbital cellulitis)\nAcute wheezing exacerbation which may require treatment with systemic corticosteroids\nKnown renal or hepatic dysfunction or insufficiency\nHistory of amoxicillin-clavulanate-associated cholestatic jaundice\nImmune dysfunction or receipt of immunosuppressive therapy; chronic gastrointestinal conditions (i.e., malabsorption, inflammatory bowel disease)\nCo-medications (systemic corticosteroids, more than one dose of systemic antimicrobial therapy within 96 hours, receipt of any investigational drug or vaccine within 30 days)\nHypersensitivity to penicillin, amoxicillin or amoxicillin-clavulanate, or phenylketonuria or known hypersensitivity to aspartame\nUnable to complete study, or no access to phone\nPreviously enrolled in this study or currently enrolled in another study", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"6 Months", "MaximumAge":"23 Months", "StdAgeList":{ "StdAge":[ "Child" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Alejandro Hoberman, MD", "OverallOfficialAffiliation":"University of Pittsburgh", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Kentucky Pediatric/Adult Research", "LocationCity":"Bardstown", "LocationState":"Kentucky", "LocationZip":"40004", "LocationCountry":"United States" },{ "LocationFacility":"Children's Hospital of Pittsburgh of UPMC", "LocationCity":"Pittsburgh", "LocationState":"Pennsylvania", "LocationZip":"15224", "LocationCountry":"United States" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"28002709", "ReferenceType":"derived", "ReferenceCitation":"Hoberman A, Paradise JL, Rockette HE, Kearney DH, Bhatnagar S, Shope TR, Martin JM, Kurs-Lasky M, Copelli SJ, Colborn DK, Block SL, Labella JJ, Lynch TG, Cohen NL, Haralam M, Pope MA, Nagg JP, Green MD, Shaikh N. Shortened Antimicrobial Treatment for Acute Otitis Media in Young Children. N Engl J Med. 2016 Dec 22;375(25):2446-2456. doi: 10.1056/NEJMoa1606043." },{ "ReferencePMID":"24911895", "ReferenceType":"derived", "ReferenceCitation":"Martin JM, Hoberman A, Paradise JL, Barbadora KA, Shaikh N, Bhatnagar S, Shope T, Block SL, Haralam MA, Kurs-Lasky M, Colborn DK, Green M. Emergence of Streptococcus pneumoniae serogroups 15 and 35 in nasopharyngeal cultures from young children with acute otitis media. Pediatr Infect Dis J. 2014 Nov;33(11):e286-90. doi: 10.1097/INF.0000000000000445." } ] } }, "IPDSharingStatementModule":{ "IPDSharing":"No" } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Amoxicillin-Clavulanate, 10 Days", "FlowGroupDescription":"Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days." },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Amoxicillin-Clavulanate, 5 Days", "FlowGroupDescription":"Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementComment":"Randomized to the treatment group.", "FlowAchievementNumSubjects":"260" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementComment":"Randomized to the treatment group.", "FlowAchievementNumSubjects":"260" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementComment":"Completed - Assessed at a final visit in Sep or at the end of the respiratory season in Apr or May.", "FlowAchievementNumSubjects":"238" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementComment":"Completed - Assessed at a final visit in Sep or at the end of the respiratory season in Apr or May.", "FlowAchievementNumSubjects":"219" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"22" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"41" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Ineligible", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"3" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"2" } ] } },{ "FlowDropWithdrawType":"Lost to Follow-up", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"10" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"19" } ] } },{ "FlowDropWithdrawType":"Withdrawal by Subject", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"9" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"20" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselinePopulationDescription":"520 children underwent randomization; 260 were randomized to the amoxicillin-clavulante 10 days group and 260 to the amoxicillin-clavulante 5 days, placebo 5 days group. 3 and 2, respectively, were found ineligible after randomization and were withdrawn by the PI. The remaining 257 and 258 participants, respectively, were the basis for analysis.", "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Amoxicillin-Clavulanate, 10 Days", "BaselineGroupDescription":"Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days." },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Amoxicillin-Clavulanate, 5 Days", "BaselineGroupDescription":"Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10." },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"257" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"258" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"515" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Customized", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"6-11 months", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"129" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"132" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"261" } ] } } ] } },{ "BaselineClassTitle":"12-17 months", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"80" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"77" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"157" } ] } } ] } },{ "BaselineClassTitle":"18-23 months", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"48" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"49" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"97" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"115" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"123" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"238" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"142" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"135" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"277" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Ethnicity (NIH/OMB)", "BaselineMeasureDescription":"Parents were asked what ethnicity they would use to describe their child.", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Hispanic or Latino", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"24" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"23" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"47" } ] } },{ "BaselineCategoryTitle":"Not Hispanic or Latino", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"233" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"235" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"468" } ] } },{ "BaselineCategoryTitle":"Unknown or Not Reported", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Race (NIH/OMB)", "BaselineMeasureDescription":"Parents were asked what race or races they would use to describe their child.", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"American Indian or Alaska Native", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":"Asian", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"7" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"5" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"12" } ] } },{ "BaselineCategoryTitle":"Native Hawaiian or Other Pacific Islander", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":"Black or African American", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"110" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"118" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"228" } ] } },{ "BaselineCategoryTitle":"White", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"116" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"110" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"226" } ] } },{ "BaselineCategoryTitle":"More than one race", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"21" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"21" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"42" } ] } },{ "BaselineCategoryTitle":"Unknown or Not Reported", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"3" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"4" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"7" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Study Site", "BaselineMeasureDescription":"Participating clinical study sites included: Children's Hospital of Pittsburgh (CHP) of University of Pittsburgh Medical Center (UPMC) Primary Care Center - Oakland, CHP of UPMC Emergency Department, Pittsburgh, Pennsylvania (PA); its affiliated University of Pittsburgh Clinical and Translational Science Institute (PittNet) Pediatric Practice-Based Research Network (PBRN) - PittNet North, East, South, City Loop, Pittsburgh, PA and Kittanning, PA; and Kentucky Pediatric/Adult Research (KPAR) and Physicians to Children and Adolescents (PTCA) Bardstown, Kentucky (KY).", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Children's Hospital of Pittsburgh (CHP)", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"163" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"163" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"326" } ] } } ] } },{ "BaselineClassTitle":"Children's Community Pediatrics", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"47" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"47" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"94" } ] } } ] } },{ "BaselineClassTitle":"Kentucky Pediatric and Adult Research", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"47" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"48" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"95" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Maternal Education", "BaselineMeasureDescription":"Parent was asked about the highest level of maternal education. High school graduate or equivalent implies the mother has graduated high school graduate or has a General Education Diploma (GED) or has attended technical school or some college or has an associates degree.", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Less than high school", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"31" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"26" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"57" } ] } } ] } },{ "BaselineClassTitle":"High school graduate or equivalent", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"150" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"169" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"319" } ] } } ] } },{ "BaselineClassTitle":"College graduate", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"76" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"62" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"138" } ] } } ] } },{ "BaselineClassTitle":"Unknown", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"1" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Type of Health Insurance", "BaselineMeasureDescription":"Type of health insurance relates to the child's insurance.", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Private", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"84" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"75" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"159" } ] } } ] } },{ "BaselineClassTitle":"Public", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"171" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"179" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"350" } ] } } ] } },{ "BaselineClassTitle":"None", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"4" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"6" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Exposure to Other Children", "BaselineMeasureDescription":"Exposed to other children is defined as a being exposed to 3 or more children for 10 or more hours per week or living in a home with at least 3 other children under the age of 18.", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Not exposed", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"109" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"105" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"214" } ] } } ] } },{ "BaselineClassTitle":"Exposed", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"148" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"153" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"301" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Acute Otitis Media Severity of Symptoms (AOM-SOS) Score", "BaselineMeasureDescription":"The AOM-SOS scale measures seven discrete items: tugging of ears, crying, irritability, difficulty sleeping, diminished activity, diminished appetite, and fever. Parents are asked to rate these symptoms in comparison with the child’s usual state, as “none,” “a little,” or “a lot,” with corresponding scores of 0, 1, and 2. Thus, total scores range from 0 to 14, with higher scores indicating greater severity of symptoms. Children must have at least a total score of 3 at enrollment to qualify for the study.", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"3-5", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"43" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"59" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"102" } ] } } ] } },{ "BaselineClassTitle":"6-8", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"75" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"70" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"145" } ] } } ] } },{ "BaselineClassTitle":"9-11", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"98" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"95" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"193" } ] } } ] } },{ "BaselineClassTitle":"12-14", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"41" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"34" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"75" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Mean AOM-SOS Score", "BaselineMeasureDescription":"The AOM-SOS scale measures seven discrete items: tugging of ears, crying, irritability, difficulty sleeping, diminished activity, diminished appetite, and fever. Parents are asked to rate these symptoms in comparison with the child’s usual state, as “none,” “a little,” or “a lot,” with corresponding scores of 0, 1, and 2. Thus, total scores range from 0 to 14, with higher scores indicating greater severity of symptoms.", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"AOM-SOS score", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"8.6", "BaselineMeasurementSpread":"2.9" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"8.2", "BaselineMeasurementSpread":"3.0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"8.4", "BaselineMeasurementSpread":"3.0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Estimated severity of illness from pain and fever history only", "BaselineMeasureDescription":"AOM episodes were categorized as “likely severe” if the parent described the child as having had “a lot” of ear tugging or “a lot” of fever during the preceding 24 hours, else the episode was categorized as \"likely nonsevere.\"", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Likely nonsevere", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"111" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"121" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"232" } ] } } ] } },{ "BaselineClassTitle":"Likely severe", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"146" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"137" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"283" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Laterality of Acute Otitis Media (AOM)", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Unilateral", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"136" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"126" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"262" } ] } } ] } },{ "BaselineClassTitle":"Bilateral", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"121" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"132" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"253" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Degree of Tympanic Membrane Bulging", "BaselineMeasureDescription":"If a child has unilateral AOM, the degree of bulging reflects the degree of bulging in the ear with AOM. If a child has bilateral AOM, the degree of bulging reflects the degree of bulging in the ear with the greater level of bulging,", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Slight", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"35" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"45" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"80" } ] } } ] } },{ "BaselineClassTitle":"Moderate", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"137" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"135" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"272" } ] } } ] } },{ "BaselineClassTitle":"Marked", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"85" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"78" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"163" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Streptococcus Pneumoniae (S pneumoniae) Sensitivity in Nasopharyngeal Cultures", "BaselineMeasureDescription":"Susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available , susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm.", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"S pneumoniae absent", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"131" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"120" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"251" } ] } } ] } },{ "BaselineClassTitle":"S pneumoniae present, susceptible", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"84" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"94" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"178" } ] } } ] } },{ "BaselineClassTitle":"S pneumoniae present, intermediate", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"20" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"28" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"48" } ] } } ] } },{ "BaselineClassTitle":"S pneumoniae present, resistant", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"21" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"16" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"37" } ] } } ] } },{ "BaselineClassTitle":"Unknown, no culture", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"1" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Haemophilus Influenzae (H influenzae) Sensitivity in Nasopharyngeal Cultures", "BaselineMeasureDescription":"Susceptible was defined as beta-lactamase-negative and E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and E test MIC >1 µg/mL.", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"H influenzae absent", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"172" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"197" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"369" } ] } } ] } },{ "BaselineClassTitle":"H influenzae present, susceptible", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"53" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"37" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"90" } ] } } ] } },{ "BaselineClassTitle":"H influenzae present, nonsusceptible", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"31" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"24" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"55" } ] } } ] } },{ "BaselineClassTitle":"Unknown, no culture", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"1" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"The Distribution of Children Categorized as Treatment Failure (TF) at or Before the Day 12-14 End-of-Treatment Visit Specific to the Index Episode of AOM", "OutcomeMeasureDescription":"Proportion of children initially diagnosed with AOM who experience treatment failure at or before the day 12-14 visit.\n\nTF is defined as substantial persistence or worsening of symptoms specifically attributable to AOM, or of otoscopic signs of AOM, after 72 hours from the time of randomization, such that additional antimicrobial therapy is deemed advisable. If a parent/legal guardian is unwilling to continue the assigned study product regimen, the participant will be categorized as TF. Should a participant be administered another systemic antibiotic while taking study medication or prior to Day 16, the participant will be considered a TF. Clinical success is defined as complete or substantial resolution of symptoms specifically attributable to AOM for 48 hours and of otoscopic signs of acute inflammation (bulging of the tympanic membrane (TM) or intense erythema), with or without persistence of middle-ear effusion, such that no additional antibiotic therapy is deemed advisable.", "OutcomeMeasurePopulationDescription":"The analysis was intent to treat (ITT). The number of participants is equal to the number of children randomized & eligible who had a clinical assessment at or before the day 12-14 visit.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"From 72 hours after randomization until day 21 of the index episode. The mean day for this visit was 13.2.", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Amoxicillin-Clavulanate, 10 Days", "OutcomeGroupDescription":"Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Amoxicillin-Clavulanate, 5 Days", "OutcomeGroupDescription":"Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"238" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"229" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Treatment failure", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"39" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"77" } ] } } ] } },{ "OutcomeClassTitle":"Treatment success", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"199" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"152" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"The null hypothesis that amoxicillin-clavulanate 5 days, placebo 5 days (reduced duration) is inferior to amoxicillin-clavulanate 10 days (standard duration) is tested against the alternative that reduced duration treatment is noninferior. Assuming failure rates of 15% and 25% in the standard and reduced duration groups, respectively, a 2-sided significance level of .05 and 10% attrition, it was calculated that 300 participants per group, would provide power of 95% for finding inferiority.", "OutcomeAnalysisNonInferiorityType":"Non-Inferiority or Equivalence", "OutcomeAnalysisNonInferiorityComment":"A noninferiority margin of 10% was used. Non-inferiority can be established by placing a confidence interval on the difference in the proportion of TFs in subjects randomized to the 10 day regimen and the proportion of TFs in subjects randomized to the 5 day regimen, and determining whether the lower 95% confidence bound is greater than -10%.", "OutcomeAnalysisParamType":"Difference between proportions", "OutcomeAnalysisParamValue":"-.172", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-.253", "OutcomeAnalysisCIUpperLimit":"-.091", "OutcomeAnalysisDispersionType":"Standard Deviation", "OutcomeAnalysisDispersionValue":".039" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"The Distribution of AOM Recurrences Categorized as Treatment Failure (TF) at or Before the Day 12-14 End-of-Treatment Visit", "OutcomeMeasureDescription":"Proportion of AOM recurrences resulting in treatment failure at or before the day 12-14 visit.\n\nTF is defined as substantial persistence or worsening of symptoms specifically attributable to AOM, or of otoscopic signs of AOM, after 72 hours from the time of the recurrence, such that additional antimicrobial therapy is deemed advisable. If a parent/legal guardian is unwilling to continue the assigned study product regimen, the participant will be categorized as TF. Should a participant be administered another systemic antibiotic while taking study medication or prior to Day 16, the participant will be considered a TF. Clinical success is defined as complete or substantial resolution of symptoms specifically attributable to AOM for 48 hours and of otoscopic signs of acute inflammation (bulging of the TM or intense erythema), with or without persistence of middle-ear effusion, such that no additional antibiotic therapy is deemed advisable.", "OutcomeMeasurePopulationDescription":"The analysis was ITT. The number of participants is equal to the number of children randomized & eligible who had a clinical assessment at or before the day 12-14 visit following an AOM recurrence.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"recurrence", "OutcomeMeasureTimeFrame":"From 72 hours after the AOM recurrence was diagnosed until day 21 of the recurrence. The mean day for this visit was 13.3.", "OutcomeMeasureTypeUnitsAnalyzed":"Recurrences", "OutcomeMeasureDenomUnitsSelected":"Recurrences", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Amoxicillin-Clavulanate, 10 Days", "OutcomeGroupDescription":"Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Amoxicillin-Clavulanate, 5 Days", "OutcomeGroupDescription":"Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"101" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"84" } ] } },{ "OutcomeDenomUnits":"Recurrences", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"133" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"102" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Treatment failure", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"25" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"29" } ] } } ] } },{ "OutcomeClassTitle":"Treatment success", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"108" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"73" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority or Equivalence", "OutcomeAnalysisNonInferiorityComment":"A noninferiority margin of 10% was used. Non-inferiority can be established by placing a confidence interval on the difference in the proportion of TFs in subjects randomized to the 10 day regimen and the proportion of TFs in subjects randomized to the 5 day regimen, and determining whether the lower 95% confidence bound is greater than -10%.", "OutcomeAnalysisParamType":"Difference between proportions", "OutcomeAnalysisParamValue":"-.096", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-.209", "OutcomeAnalysisCIUpperLimit":".016", "OutcomeAnalysisDispersionType":"Standard Deviation", "OutcomeAnalysisDispersionValue":".053" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"The Distribution of Children With a Nasopharyngeal (NP) Culture at Enrollment That is Negative for AOM Pathogens in Which the Follow-up NP Culture at Day 12-14 Yields a Nonsusceptible Pathogen", "OutcomeMeasureDescription":"AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.", "OutcomeMeasurePopulationDescription":"The analysis was ITT. The participants are randomized & eligible children having a NP culture at enrollment that is negative for both S pn and H flu and a NP culture at the day 12-14 visit which is either positive (+) for >=1 penicillin nonsusceptible pathogen OR pathogen negative (-) or + only for >=1 penicillin susceptible pathogen.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"The day 12-14 visit. The mean day for this visit was 13.3.", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Amoxicillin-Clavulanate, 10 Days", "OutcomeGroupDescription":"Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Amoxicillin-Clavulanate, 5 Days", "OutcomeGroupDescription":"Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"75" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"72" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"+ for nonsusceptible pathogen(s) day 12-14", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"15" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"11" } ] } } ] } },{ "OutcomeClassTitle":"pathogen - or + only for susceptible day 12-14", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"60" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"61" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Null hypothesis: There is no difference between the two groups in the proportion of children whose NP isolates at enrollment are negative for AOM pathogens for whom the NP culture at day 12-14 yields a nonsusceptible pathogen.", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.45", "OutcomeAnalysisStatisticalMethod":"Regression, Logistic" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"The Distribution of AOM Recurrences With a Nasopharyngeal (NP) Culture at Onset That is Negative for AOM Pathogens in Which the Follow-up NP Culture at Day 12-14 Yields a Nonsusceptible Pathogen", "OutcomeMeasureDescription":"AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.", "OutcomeMeasurePopulationDescription":"The analysis was ITT. The participants are randomized & eligible children having a NP culture at onset that is negative for both S pn and H flu and a NP culture at the day 12-14 visit which is either positive (+) for >=1 penicillin nonsusceptible pathogen OR pathogen negative (-) or + only for >=1 penicillin susceptible pathogen.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"recurrence", "OutcomeMeasureTimeFrame":"The day 12-14 visit. The mean day for this visit was 13.4.", "OutcomeMeasureTypeUnitsAnalyzed":"Recurrences", "OutcomeMeasureDenomUnitsSelected":"Recurrences", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Amoxicillin-Clavulanate, 10 Days", "OutcomeGroupDescription":"Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Amoxicillin-Clavulanate, 5 Days", "OutcomeGroupDescription":"Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"42" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"26" } ] } },{ "OutcomeDenomUnits":"Recurrences", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"46" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"32" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"+ for nonsusceptible pathogen(s) day 12-14", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"12" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"8" } ] } } ] } },{ "OutcomeClassTitle":"pathogen - or + only for susceptible day 12-14", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"34" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"24" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Null hypothesis: For AOM recurrences with a NP culture at onset that is negative for AOM pathogens, there is no difference between the two groups regarding the proportion of NP cultures at Day 12-14 that yield a nonsusceptible pathogen.", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.95", "OutcomeAnalysisStatisticalMethod":"Generalized estimating equations" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"The Distribution of Children With a Nasopharyngeal (NP) Culture at Enrollment That is Positive Only for One or More Susceptible Pathogens in Which the Follow-up NP Culture at Day 12-14 Yields a Nonsusceptible Pathogen", "OutcomeMeasureDescription":"AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.", "OutcomeMeasurePopulationDescription":"The analysis was ITT. The participants are randomized & eligible children having a NP culture at enrollment that is positive only for >=1 susceptible pathogen & a NP culture at the day 12-14 visit which is either positive (+) for >=1 penicillin nonsusceptible pathogen OR pathogen negative (-) or + only for >=1 penicillin susceptible pathogen.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"The day 12-14 visit. The mean day for this visit was 13.2.", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Amoxicillin-Clavulanate, 10 Days", "OutcomeGroupDescription":"Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Amoxicillin-Clavulanate, 5 Days", "OutcomeGroupDescription":"Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"93" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"90" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"+ for nonsusceptible pathogen(s) day 12-14", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"10" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"12" } ] } } ] } },{ "OutcomeClassTitle":"pathogen - or + only for susceptible day 12-14", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"83" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"78" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Null hypothesis: There is no difference between the two groups in the proportion of children whose NP isolates at enrollment are positive only for one or more susceptible pathogens for whom the NP culture at day 12-14 yields a nonsusceptible pathogen.", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.59", "OutcomeAnalysisStatisticalMethod":"Regression, Logistic" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"The Distribution of AOM Recurrences With a Nasopharyngeal (NP) Culture at Onset That is Positive Only for One or More Susceptible Pathogens in Which the Follow-up NP Culture at Day 12-14 Yields a Nonsusceptible Pathogen", "OutcomeMeasureDescription":"AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.", "OutcomeMeasurePopulationDescription":"The analysis was ITT. The participants are randomized & eligible children having a NP culture at onset that is positive (+) only for one or more susceptible pathogens & a NP culture at the day 12-14 visit which is either + for >=1 penicillin nonsusceptible pathogen OR pathogen negative (-) or + only for >=1 penicillin susceptible pathogen.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"recurrence", "OutcomeMeasureTimeFrame":"The day 12-14 visit. The mean day for this visit was 13.9.", "OutcomeMeasureTypeUnitsAnalyzed":"Recurrences", "OutcomeMeasureDenomUnitsSelected":"Recurrences", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Amoxicillin-Clavulanate, 10 Days", "OutcomeGroupDescription":"Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Amoxicillin-Clavulanate, 5 Days", "OutcomeGroupDescription":"Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"39" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"32" } ] } },{ "OutcomeDenomUnits":"Recurrences", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"44" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"33" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"+ for nonsusceptible pathogen(s) day 12-14", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"8" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"6" } ] } } ] } },{ "OutcomeClassTitle":"pathogen - or + only for susceptible day 12-14", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"36" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"27" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Null hypothesis: For AOM recurrences with a NP culture at onset that is positive only for one or more susceptible pathogens, there is no difference between the two groups regarding the proportion of NP cultures at Day 12-14 that yield a nonsusceptible pathogen.", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":">0.99", "OutcomeAnalysisStatisticalMethod":"Generalized estimating equations" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"The Distribution of Children With a Nasopharyngeal (NP) Culture at Enrollment That is Positive for One or More Nonsusceptible Pathogens in Which the Follow-up NP Culture at Day 12-14 Yields a Nonsusceptible Pathogen", "OutcomeMeasureDescription":"AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.", "OutcomeMeasurePopulationDescription":"The analysis was ITT. The participants are randomized & eligible children having both a NP culture at enrollment that is positive (+) for one or more nonsusceptible pathogens & a NP culture at the day 12-14 visit which is either + for >=1 penicillin nonsusceptible pathogen OR pathogen negative (-) or + only for >=1 penicillin susceptible pathogen.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"The end-of-treatment visit. The mean day for this visit was 13.6.", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Amoxicillin-Clavulanate, 10 Days", "OutcomeGroupDescription":"Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Amoxicillin-Clavulanate, 5 Days", "OutcomeGroupDescription":"Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"64" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"60" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"+ for nonsusceptible pathogen(s) day 12-14", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"34" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"28" } ] } } ] } },{ "OutcomeClassTitle":"pathogen - or + only for susceptible day 12-14", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"30" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"32" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Null hypothesis: There is no difference between the two groups in the proportion of children whose NP isolates at enrollment are positive for one or more nonsusceptible pathogens for whom the NP culture at day 12-14 yields a nonsusceptible pathogen.", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.47", "OutcomeAnalysisStatisticalMethod":"Regression, Logistic" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"The Distribution of AOM Recurrences With a Nasopharyngeal (NP) Culture at Onset That is Positive for One or More Nonsusceptible Pathogens in Which the Follow-up NP Culture at Day 12-14 Yields a Nonsusceptible Pathogen", "OutcomeMeasureDescription":"AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.", "OutcomeMeasurePopulationDescription":"The analysis was ITT. The participants are randomized & eligible children having a NP culture at onset that is positive (+) for >=1 nonsusceptible pathogen & a NP culture at the day 12-14 visit which is either + for >=1 penicillin nonsusceptible pathogen OR pathogen negative (-) or + only for >=1 penicillin susceptible pathogen.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"recurrence", "OutcomeMeasureTimeFrame":"The end-of-treatment visit. The mean day for this visit was 13.4.", "OutcomeMeasureTypeUnitsAnalyzed":"Recurrences", "OutcomeMeasureDenomUnitsSelected":"Recurrences", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Amoxicillin-Clavulanate, 10 Days", "OutcomeGroupDescription":"Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Amoxicillin-Clavulanate, 5 Days", "OutcomeGroupDescription":"Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"29" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"27" } ] } },{ "OutcomeDenomUnits":"Recurrences", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"33" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"29" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"+ for nonsusceptible pathogen(s) day 12-14", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"17" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"22" } ] } } ] } },{ "OutcomeClassTitle":"pathogen - or + only for susceptible day 12-14", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"16" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"7" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Null hypothesis: For AOM recurrences with a NP culture at onset that is positive for one or more nonsusceptible pathogens, there is no difference between the two groups regarding the proportion of NP cultures at Day 12-14 that yield a nonsusceptible pathogen.", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.05", "OutcomeAnalysisStatisticalMethod":"Generalized estimating equations" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"The Distribution of Children Whose Nasopharyngeal (NP) Isolates at Enrollment Are Pathogen Negative or Positive Only for at Least One Susceptible Pathogen Who Become Colonized With Nonsusceptible Pathogens at Any Time Over the Course of Follow-up", "OutcomeMeasureDescription":"AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.", "OutcomeMeasurePopulationDescription":"The analysis was ITT. The participants are randomized & eligible children having both a NP culture at enrollment that is either pathogen negative or positive only for >=1 susceptible pathogen and a NP culture at some time over the course of followup.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"Day 1 of study entry until day 365", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Amoxicillin-Clavulanate, 10 Days", "OutcomeGroupDescription":"Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Amoxicillin-Clavulanate, 5 Days", "OutcomeGroupDescription":"Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"181" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"177" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"+ for a nonsusceptible pathogen during followup", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"85" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"78" } ] } } ] } },{ "OutcomeClassTitle":"- for a nonsusceptible pathogen during followup", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"96" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"99" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Null hypothesis: There is no difference in the proportion of subjects whose NP isolates at enrollment are pathogen-negative or positive only for at least one susceptible pathogen who become colonized with penicillin non-susceptible pathogens at any time over the course of follow-up", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.58", "OutcomeAnalysisStatisticalMethod":"Regression, Logistic", "OutcomeAnalysisStatisticalComment":"The p-value is adjusted for the culture result at enrollment." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"The Distribution of 6 Week Follow-up, Non-Illness Visits During the Respiratory Season at Which a Nonsusceptible Pathogen is Recovered", "OutcomeMeasureDescription":"AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.", "OutcomeMeasurePopulationDescription":"The analysis was ITT. The participants are randomized & eligible children with at least one follow-up, nonillness visit, with a nasopharyngeal (NP) culture which is either positive (+) for >=1 penicillin nonsusceptible pathogens or positive (+) only for >=1 penicillin susceptible pathogens or pathogen negative (-).", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Visit", "OutcomeMeasureTimeFrame":"Day 1 of study entry until day 244. The respiratory season is October 1 - May 31, inclusive.", "OutcomeMeasureTypeUnitsAnalyzed":"Visits", "OutcomeMeasureDenomUnitsSelected":"Visits", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Amoxicillin-Clavulanate, 10 Days", "OutcomeGroupDescription":"Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Amoxicillin-Clavulanate, 5 Days", "OutcomeGroupDescription":"Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"211" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"189" } ] } },{ "OutcomeDenomUnits":"Visits", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"415" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"359" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"+ for nonsusceptible pathogen(s)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"79" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"64" } ] } } ] } },{ "OutcomeClassTitle":"pathogen - or + only for susceptible pathogen(s)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"336" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"295" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Null hypothesis: There is no difference in the proportion of 6 week follow-up, non-illness visits at which a penicillin-nonsusceptible pathogen is recovered.", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.74", "OutcomeAnalysisStatisticalMethod":"Generalized estimating equations" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"The Distribution of Children for Whom the Follow-up Nasopharyngeal (NP) Culture at the Day 12-14 Visit, Specific to the Index Episode, Yields a Nonsusceptible Streptococcus Pneumoniae (S pn) Isolate", "OutcomeMeasureDescription":"In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm.", "OutcomeMeasurePopulationDescription":"The analysis was ITT. The number of participants is equal to the number of children randomized & eligible having a NP culture at the day 12-14 visit following the index episode.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"The day 12-14 visit specific to the index episode. The mean day for this visit was 13.4.", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Amoxicillin-Clavulanate, 10 Days", "OutcomeGroupDescription":"Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Amoxicillin-Clavulanate, 5 Days", "OutcomeGroupDescription":"Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"233" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"222" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"S pn, nonsusceptible", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"23" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"26" } ] } } ] } },{ "OutcomeClassTitle":"S pn, susceptible", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"10" } ] } } ] } },{ "OutcomeClassTitle":"S pn, absent", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"205" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"186" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Null hypothesis: There is no difference between the two groups regarding the proportion of NP cultures at Day 12-14 that yield a nonsusceptible S pn isolate.", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.72", "OutcomeAnalysisStatisticalMethod":"Regression, Logistic", "OutcomeAnalysisStatisticalComment":"The p-value is adjusted for S pn susceptibility at the index episode." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"The Distribution of AOM Recurrences for Which the Follow-up Nasopharyngeal (NP) Culture at the Day 12-14 Visit Yields a Nonsusceptible Streptococcus Pneumoniae (S pn) Isolate", "OutcomeMeasureDescription":"In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm.", "OutcomeMeasurePopulationDescription":"The analysis was ITT. The number of participants is equal to the number of children randomized & eligible having a NP culture at the day 12-14 visit following an AOM recurrence.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"recurrence", "OutcomeMeasureTimeFrame":"The day 12-14 visit following a recurrence. The mean day for this visit was 13.6.", "OutcomeMeasureTypeUnitsAnalyzed":"Recurrences", "OutcomeMeasureDenomUnitsSelected":"Recurrences", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Amoxicillin-Clavulanate, 10 Days", "OutcomeGroupDescription":"Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Amoxicillin-Clavulanate, 5 Days", "OutcomeGroupDescription":"Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"100" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"82" } ] } },{ "OutcomeDenomUnits":"Recurrences", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"131" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"99" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"S pn, nonsusceptible", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"20" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"25" } ] } } ] } },{ "OutcomeClassTitle":"S pn, susceptible", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"6" } ] } } ] } },{ "OutcomeClassTitle":"S pn, absent", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"107" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"68" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.05", "OutcomeAnalysisStatisticalMethod":"Generalized estimating equations", "OutcomeAnalysisStatisticalComment":"The p-value is adjusted for S pn susceptibility at onset of the AOM recurrence." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"The Distribution of Children for Whom the Follow-up Nasopharyngeal (NP) Culture at the Day 12-14 Visit, Specific to the Index Episode, Yields a Nonsusceptible Haemophilus Influenzae (H Flu) Isolate", "OutcomeMeasureDescription":"In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.", "OutcomeMeasurePopulationDescription":"The analysis was ITT. The number of participants is equal to the number of children randomized & eligible having a NP culture at the day 12-14 visit following the index episode.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"The day 12-14 visit specific to the index episode. The mean day for this visit was 13.4.", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Amoxicillin-Clavulanate, 10 Days", "OutcomeGroupDescription":"Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Amoxicillin-Clavulanate, 5 Days", "OutcomeGroupDescription":"Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"233" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"222" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"H flu, nonsusceptible", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"38" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"28" } ] } } ] } },{ "OutcomeClassTitle":"H flu, susceptible", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"39" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"37" } ] } } ] } },{ "OutcomeClassTitle":"H flu, absent", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"156" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"157" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Null hypothesis: There is no difference between the two groups regarding the proportion of NP cultures at Day 12-14 that yield a nonsusceptible H flu isolate.", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.47", "OutcomeAnalysisStatisticalMethod":"Regression, Logistic", "OutcomeAnalysisStatisticalComment":"The p-value is adjusted for H flu susceptibility at onset of the index episode." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"The Distribution of AOM Recurrences for Which the Follow-up Nasopharyngeal (NP) Culture at the Day 12-14 Visit Yields a Nonsusceptible Haemophilus Influenzae (H Flu) Isolate", "OutcomeMeasureDescription":"In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.", "OutcomeMeasurePopulationDescription":"The analysis was ITT. The number of participants is equal to the number of children randomized & eligible having a NP culture at the day 12-14 visit following an AOM recurrence.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"recurrence", "OutcomeMeasureTimeFrame":"The day 12-14 visit following a recurrence. The mean day for this visit was 13.6.", "OutcomeMeasureTypeUnitsAnalyzed":"Recurrences", "OutcomeMeasureDenomUnitsSelected":"Recurrences", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Amoxicillin-Clavulanate, 10 Days", "OutcomeGroupDescription":"Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Amoxicillin-Clavulanate, 5 Days", "OutcomeGroupDescription":"Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"100" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"82" } ] } },{ "OutcomeDenomUnits":"Recurrences", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"131" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"99" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"H flu, nonsusceptible", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"19" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"15" } ] } } ] } },{ "OutcomeClassTitle":"H flu, susceptible", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"17" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"20" } ] } } ] } },{ "OutcomeClassTitle":"H flu, absent", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"95" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"64" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.69", "OutcomeAnalysisStatisticalMethod":"Generalized estimating equations", "OutcomeAnalysisStatisticalComment":"The p-value is adjusted for H flu susceptibility at onset of the AOM recurrence." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"The Distribution of Children With AOM Recurrences and Relapses Within 60 Days of Enrollment", "OutcomeMeasureDescription":"An episode of AOM occurring after Day 16 will be considered a recurrence. Subjects seen after day 10 and categorized as clinical success who return for an interim/sick visit before day 17 and are found to have AOM will be categorized as a relapse. For secondary outcome analyses, relapses are combined with recurrences.", "OutcomeMeasurePopulationDescription":"The analysis was ITT. The participants are randomized & eligible children having follow-up greater than or equal to day 60.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"Day 1 of study entry until day 60.", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Amoxicillin-Clavulanate, 10 Days", "OutcomeGroupDescription":"Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Amoxicillin-Clavulanate, 5 Days", "OutcomeGroupDescription":"Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"241" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"224" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"# cumulative recurrences/relapses = 0", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"173" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"173" } ] } } ] } },{ "OutcomeClassTitle":"# cumulative recurrences/relapses = 1", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"66" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"48" } ] } } ] } },{ "OutcomeClassTitle":"# cumulative recurrences/relapses = 2", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Null hypothesis: There is no difference between the two groups in the proportion of children followed greater than 60 days having at least one AOM relapse or recurrence within 60 days of enrollment.", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.16", "OutcomeAnalysisStatisticalMethod":"Regression, Logistic", "OutcomeAnalysisStatisticalComment":"The p-value is adjusted for site & the stratification variables, namely age group & exposure or nonexposure to ≥3 children for ≥10 hours per week." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"The Distribution of Children With AOM Recurrences and Relapses Within the Entire Respiratory Season", "OutcomeMeasureDescription":"An episode of AOM occurring after Day 16 will be considered a recurrence. Subjects seen after day 10 and categorized as clinical success who return for an interim/sick visit before day 17 and are found to have AOM will be categorized as a relapse. For secondary outcome analyses, relapses are combined with recurrences.", "OutcomeMeasurePopulationDescription":"The analysis was ITT. The participants are randomized & eligible children completing the study.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"Day 1 of study entry until day 244. The respiratory season is October 1 - May 31, inclusive.", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Amoxicillin-Clavulanate, 10 Days", "OutcomeGroupDescription":"Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Amoxicillin-Clavulanate, 5 Days", "OutcomeGroupDescription":"Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"238" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"219" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"# cumulative recurrences/relapses = 0", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"135" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"133" } ] } } ] } },{ "OutcomeClassTitle":"# cumulative recurrences/relapses = 1", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"61" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"59" } ] } } ] } },{ "OutcomeClassTitle":"# cumulative recurrences/relapses = 2", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"31" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"20" } ] } } ] } },{ "OutcomeClassTitle":"# cumulative recurrences/relapses = 3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"8" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"4" } ] } } ] } },{ "OutcomeClassTitle":"# cumulative recurrences/relapses = 4", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Null hypothesis: There is no difference between the two groups in the proportion of children completing the study having at least one AOM relapse or recurrence within the entire respiratory season.", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.32", "OutcomeAnalysisStatisticalMethod":"Regression, Logistic", "OutcomeAnalysisStatisticalComment":"The p-value is adjusted for site & the stratification variables, namely age group & exposure or nonexposure to ≥3 children for ≥10 hours per week." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"The Mean Rate, Per Month, of Protocol AOM Recurrences and Relapses Within 60 Days of Enrollment", "OutcomeMeasureDescription":"An episode of AOM occurring after Day 16 will be considered a recurrence. Subjects seen after day 10 and categorized as clinical success who return for an interim/sick visit before day 17 and are found to have AOM will be categorized as a relapse. For secondary outcome analyses, relapses are combined with recurrences.\n\nThe rate, expressed as a monthly rate, is calculated by dividing the total number of recurrences and relapses within 60 days of enrollment by the number of months of follow-up within 60 days of enrollment.", "OutcomeMeasurePopulationDescription":"The analysis was ITT. The participants are randomized & eligible children having follow-up beyond day 16.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"recurrences/relapses per month", "OutcomeMeasureTimeFrame":"Day 1 of study entry until day 60.", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Amoxicillin-Clavulanate, 10 Days", "OutcomeGroupDescription":"Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Amoxicillin-Clavulanate, 5 Days", "OutcomeGroupDescription":"Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"245" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"232" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.15", "OutcomeMeasurementSpread":"0.24" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.12", "OutcomeMeasurementSpread":"0.23" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Null hypothesis: There is no difference between the two groups in the rate of recurrences/relapses within 60 days of enrollment.", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.23", "OutcomeAnalysisStatisticalMethod":"Regression, Poisson", "OutcomeAnalysisStatisticalComment":"The p-value is adjusted for site & the stratification variables, namely age group & exposure or nonexposure to ≥3 children for ≥10 hours per week." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"The Mean Rate, Per Month, of Protocol AOM Recurrences and Relapses Within the Entire Respiratory Season", "OutcomeMeasureDescription":"An episode of AOM occurring after Day 16 will be considered a recurrence. Subjects seen after day 10 and categorized as clinical success who return for an interim/sick visit before day 17 and are found to have AOM will be categorized as a relapse. For secondary outcome analyses, relapses are combined with recurrences.\n\nThe rate, expressed as a monthly rate, is calculated by dividing the total number of recurrences and relapses by the number of months of follow-up.", "OutcomeMeasurePopulationDescription":"The analysis was ITT. The participants are randomized & eligible children having follow-up beyond day 16.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"recurrences/relapses per months followed", "OutcomeMeasureTimeFrame":"Day 1 of study entry until day 244. The respiratory season is October 1 - May 31, inclusive.", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Amoxicillin-Clavulanate, 10 Days", "OutcomeGroupDescription":"Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Amoxicillin-Clavulanate, 5 Days", "OutcomeGroupDescription":"Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"245" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"232" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.14", "OutcomeMeasurementSpread":"0.18" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.12", "OutcomeMeasurementSpread":"0.19" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Null hypothesis: There is no difference between the two groups in the rate of recurrences/relapses within the entire respiratory season.", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.22", "OutcomeAnalysisStatisticalMethod":"Regression, Poisson", "OutcomeAnalysisStatisticalComment":"The p-value is adjusted for site & the stratification variables, namely age group & exposure or nonexposure to ≥3 children for ≥10 hours per week." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"The Mean Number of Days Systemic Antibiotics Were Received During the Entire Respiratory Season", "OutcomeMeasureDescription":"Systemic antibiotics include the study product, Amoxicillin-Clavulanate, dispensed for either 10 or 5 days and various concomitant medications, i.e. Amoxicillin, Amox/Clav, Azithromycin, Cefdinir, Cefpodoxime, Ceftriaxone, Erythromycin, Trimethoprim-Sulfamethoxazole, Omnicef, Augmentin, Azithromycin, Cefazolin, Clarythromycin and Ciprofloxacin.", "OutcomeMeasurePopulationDescription":"The analysis was ITT. The number of participants is equal to the number of children randomized & eligible.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"days", "OutcomeMeasureTimeFrame":"Day 1 of study entry until day 244. The respiratory season is October 1 - May 31, inclusive.", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Amoxicillin-Clavulanate, 10 Days", "OutcomeGroupDescription":"Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Amoxicillin-Clavulanate, 5 Days", "OutcomeGroupDescription":"Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"257" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"258" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Study product", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"14.72", "OutcomeMeasurementSpread":"6.77" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"6.79", "OutcomeMeasurementSpread":"3.01" } ] } } ] } },{ "OutcomeClassTitle":"Other systemic antibiotic", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"6.19", "OutcomeMeasurementSpread":"9.33" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"7.98", "OutcomeMeasurementSpread":"10.94" } ] } } ] } },{ "OutcomeClassTitle":"All systemic antibiotics", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"20.91", "OutcomeMeasurementSpread":"12.70" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"14.77", "OutcomeMeasurementSpread":"12.10" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Null hypothesis: There is no difference between the two groups in the mean number of days a systemic antibiotic was received during the respiratory season.", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<.001", "OutcomeAnalysisStatisticalMethod":"Regression, Linear", "OutcomeAnalysisStatisticalComment":"The p-value is adjusted for site & the stratification variables and for length of follow-up." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"The Mean Acute Otitis Media - Severity of Symptom (AOM-SOS) Scores Days 6 to 14", "OutcomeMeasureDescription":"The AOM-SOS scale measures seven discrete items: tugging of ears, crying, irritability, difficulty sleeping, diminished activity, diminished appetite, and fever. The parent rated each of these symptoms in comparison with the child's usual state, as \"none,\" \"a little,\" or \"a lot,\" with corresponding scores of 0, 1, and 2, and recorded the ratings in a diary. Each set of ratings was summed to obtain an AOM-SOS score as a measure of symptom burden. Total scores range from 0 to 14, with higher scores indicating greater severity of symptoms. For instances in which the participant was declared a treatment failure, scores are included up to, but not including the day of the failure. Otherwise, scores day 6 to day 14 are included.", "OutcomeMeasurePopulationDescription":"The analysis was ITT. The number of participants equals the number of children with at least one AOM-SOS score from day 6 of administration of study product to day 14. The scores were based on diaries completed at home by the child's parent.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"AOM-SOS score", "OutcomeMeasureTimeFrame":"From day 6 of administration of study product until day 14 for all episodes", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Amoxicillin-Clavulanate, 10 Days", "OutcomeGroupDescription":"Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Amoxicillin-Clavulanate, 5 Days", "OutcomeGroupDescription":"Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"234" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"230" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Day 6", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.72", "OutcomeMeasurementSpread":"2.14" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.64", "OutcomeMeasurementSpread":"2.38" } ] } } ] } },{ "OutcomeClassTitle":"Day 7", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.46", "OutcomeMeasurementSpread":"2.11" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.57", "OutcomeMeasurementSpread":"2.53" } ] } } ] } },{ "OutcomeClassTitle":"Day 8", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.29", "OutcomeMeasurementSpread":"1.99" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.56", "OutcomeMeasurementSpread":"2.38" } ] } } ] } },{ "OutcomeClassTitle":"Day 9", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.29", "OutcomeMeasurementSpread":"2.10" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.41", "OutcomeMeasurementSpread":"2.22" } ] } } ] } },{ "OutcomeClassTitle":"Day 10", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.12", "OutcomeMeasurementSpread":"1.96" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.43", "OutcomeMeasurementSpread":"2.36" } ] } } ] } },{ "OutcomeClassTitle":"Day 11", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.02", "OutcomeMeasurementSpread":"1.84" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.40", "OutcomeMeasurementSpread":"2.27" } ] } } ] } },{ "OutcomeClassTitle":"Day 12", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.07", "OutcomeMeasurementSpread":"1.83" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.25", "OutcomeMeasurementSpread":"2.12" } ] } } ] } },{ "OutcomeClassTitle":"Day 13", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.15", "OutcomeMeasurementSpread":"1.97" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.40", "OutcomeMeasurementSpread":"2.47" } ] } } ] } },{ "OutcomeClassTitle":"Day 14", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.16", "OutcomeMeasurementSpread":"1.93" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.37", "OutcomeMeasurementSpread":"2.39" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Null hypothesis: There is no difference between the two groups regarding the symptom burden as measured by the respective mean scores over time.", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.07", "OutcomeAnalysisStatisticalMethod":"Generalized estimating equations", "OutcomeAnalysisStatisticalComment":"The p-value is adjusted for site & the stratification variables, episode, day of the diary and AOM-SOS score at the episode." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"The Distribution of Children for Whom Protocol-Defined Diarrhea (PDD) Was Reported and Associated With Study Product", "OutcomeMeasureDescription":"Protocol-defined diarrhea is defined as the occurrence of three or more watery stools in 1 day or two watery stools daily for 2 consecutive days and is limited to events associated with study product.", "OutcomeMeasurePopulationDescription":"The analysis was ITT. The number of participants equals the number of children randomized and eligible.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"Day 1 of administration of study product until day 16 for all episodes", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Amoxicillin-Clavulanate, 10 Days", "OutcomeGroupDescription":"Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Amoxicillin-Clavulanate, 5 Days", "OutcomeGroupDescription":"Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"257" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"258" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"PDD reported", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"78" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"75" } ] } } ] } },{ "OutcomeClassTitle":"PDD not reported", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"179" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"183" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Null hypothesis: There is no difference between the two groups in the proportion of children for whom PDD was reported.", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.70", "OutcomeAnalysisStatisticalMethod":"Regression, Logistic", "OutcomeAnalysisStatisticalComment":"The p-value is adjusted for site & the stratification variables, namely age group & exposure or nonexposure to ≥3 children for ≥10 hours per week." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"The Distribution of Children for Whom Diaper Dermatitis Was Reported and Associated With Study Product", "OutcomeMeasureDescription":"Diaper dermatitis is defined as dermatitis in the diaper area calling for prescription of a topical antifungal agent and is limited to events associated with study product.", "OutcomeMeasurePopulationDescription":"The analysis was ITT. The number of participants equals the number of children randomized and eligible.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"Day 1 of administration of study product until day 16 for all episodes", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Amoxicillin-Clavulanate, 10 Days", "OutcomeGroupDescription":"Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Amoxicillin-Clavulanate, 5 Days", "OutcomeGroupDescription":"Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"257" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"258" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Diaper dermatitis reported", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"85" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"87" } ] } } ] } },{ "OutcomeClassTitle":"Diaper dermatitis not reported", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"172" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"171" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Null hypothesis: There is no difference between the two groups in the proportion of children for whom diaper dermatitis was reported.", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.86", "OutcomeAnalysisStatisticalMethod":"Regression, Logistic", "OutcomeAnalysisStatisticalComment":"The p-value is adjusted for site & the stratification variables, namely age group & exposure or nonexposure to ≥3 children for ≥10 hours per week." } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"4", "EventsTimeFrame":"Parents were interviewed at each scheduled study visit (Day 1, Day 12-14, Day 16-30, 6 week), at the Day 4-6 phone call, at interim illness visits through May 31st, and at the final September visit to determine if their child had any adverse events.", "EventsDescription":"Staff reviewed child's medical records since their last study visit for any adverse events (AEs). A medical condition that was present at the time that the child was screened was considered baseline and not reported as an AE. If the severity of any pre-existing medical condition increased at any time during the study, it was reported as an AE.", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Amoxicillin-Clavulanate, 10 Days", "EventGroupDescription":"Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.", "EventGroupSeriousNumAffected":"3", "EventGroupSeriousNumAtRisk":"257", "EventGroupOtherNumAffected":"240", "EventGroupOtherNumAtRisk":"257" },{ "EventGroupId":"EG001", "EventGroupTitle":"Amoxicillin-Clavulanate, 5 Days", "EventGroupDescription":"Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.", "EventGroupSeriousNumAffected":"5", "EventGroupSeriousNumAtRisk":"258", "EventGroupOtherNumAffected":"242", "EventGroupOtherNumAtRisk":"258" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"Gastroenteritis", 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