{ "FullStudy":{ "Rank":218216, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01511224", "OrgStudyIdInfo":{ "OrgStudyId":"NTUH-TD-B-111-001" }, "Organization":{ "OrgFullName":"National Taiwan University Hospital", "OrgClass":"OTHER" }, "BriefTitle":"A Prospective Observational Study of Patients With Drug Resistant Acinetobacter Baumannii Bacteremia", "OfficialTitle":"A Prospective Observational Study of Patients With Drug Resistant Acinetobacter Baumannii Bacteremia Treated With Antibiotics Therapy", "Acronym":"ANTI-AB" }, "StatusModule":{ "StatusVerifiedDate":"January 2012", "OverallStatus":"Unknown status", "LastKnownStatus":"Recruiting", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"August 2010" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"December 2012", "PrimaryCompletionDateType":"Anticipated" }, "CompletionDateStruct":{ "CompletionDate":"June 2013", "CompletionDateType":"Anticipated" }, "StudyFirstSubmitDate":"January 12, 2012", "StudyFirstSubmitQCDate":"January 17, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 18, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 17, 2012", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 18, 2012", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"National Taiwan University Hospital", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"Far Eastern Memorial Hospital", "CollaboratorClass":"OTHER" } ] } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"Extensively and multi-drug resistant A. baumannii (AB) represent an emerging threat in hospitals locally and worldwide. There is lack of prospective comparative clinical data to guide optimal strategy for treating such infections. Since it remains unclear how to treat bacteremia caused by AB, the present study aims to enroll patients at multiple sites with extensively drug resistant Acinetobacter species bacteremia receiving different combination therapy to assess treatment outcomes and analyze risk factors associated with mortality.", "DetailedDescription":"Patients with AB bacteremia receiving antimicrobial therapy are eligible for this multicenter study. Antimicrobial agents are decided at the discretion of the attending clinical team. Clinical data to be collected include patient demographics (age, gender, underlying diseases, Pitt Bacteremia Score [20], duration of ICU stay and hospitalization before the day of first positive blood culture, central venous catheterization), antimicrobial agents on the day of bacteremia, regimens and durations of combination therapy after enrollment, and outcomes (sequential quantification change of blood A. baumannii polymerase chain reaction [PCR], survival at day 30 after enrollment, and adverse drug reactions of antimicrobial agents). Blood sample will be collected on the day of enrollment (Day 0), Day 1, 2, 3 and 7 for PCR quantification of A. baumannii and for genospecies identification. Primary end points are the interval from study enrollment to negative blood A. baumannii PCR and blood sterilization. Secondary end points are survival at 14 and 30-day after enrollment, adverse drug reactions of antimicrobial agents, and risk factors for survival at 30-day after enrollment. Inclusion criteria: 1. Adults >16 years 2. With blood culture isolate(s) A. baumannii. 3. Informed consent gained. Exclusion criteria: 1. Second/repeat episodes of bacteremia 2. Patients who could not or did not receive antimicrobial treatment 3. Patient not admitted to hospital." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Acinetobacter Bacteraemia" ] }, "KeywordList":{ "Keyword":[ "Bloodstream infections", "Acinetobacter", "Drug resistant Acinetobacter baumannii bacteremia" ] } }, "DesignModule":{ "StudyType":"Observational", "DesignInfo":{ "DesignObservationalModelList":{ "DesignObservationalModel":[ "Cohort" ] }, "DesignTimePerspectiveList":{ "DesignTimePerspective":[ "Prospective" ] } }, "BioSpec":{ "BioSpecRetention":"Samples With DNA", "BioSpecDescription":"Blood sample will be collected on the day of enrollment (Day 0), Day 1, 2, 3 and 7 for PCR identification and quantification of Acinetobacter species." }, "EnrollmentInfo":{ "EnrollmentCount":"200", "EnrollmentType":"Anticipated" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Colistin monotherapy" },{ "ArmGroupLabel":"Colistin based combination therapy", "ArmGroupDescription":"Colistin-Tigecycline, Colistin-Carbapenem, Colistin-Rifampin, Colistin-HD Unasyn" },{ "ArmGroupLabel":"Non-colistin containing regime" },{ "ArmGroupLabel":"Glycopeptide with colistin combination" },{ "ArmGroupLabel":"Colistin with loading dose" } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Microbiological clearance from blood", "PrimaryOutcomeDescription":"Interval from positive to negative blood A. baumannii PCR and blood sterilization.", "PrimaryOutcomeTimeFrame":"Day 0,1,2,3,7" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Survival", "SecondaryOutcomeDescription":"Survival at 14, 30-day after enrollment. Survival to discharge.", "SecondaryOutcomeTimeFrame":"14, 30, in-hospital stay" },{ "SecondaryOutcomeMeasure":"Adverse drug reactions", "SecondaryOutcomeDescription":"Nephrotoxicity by RIFLE criteria", "SecondaryOutcomeTimeFrame":"Day 0,1,2,3,7,14" },{ "SecondaryOutcomeMeasure":"Subsequent infections and colonization", "SecondaryOutcomeTimeFrame":"During same admission or within 1 week of discharge" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nAdults ( >16 years)\nWith blood culture isolate(s) A. baumannii\nInformed consent gained\n\nExclusion Criteria:\n\nSecond/repeat episodes of bacteremia\nPatients who could not or did not receive antimicrobial treatment\nPatient not admitted to hospital", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"16 Years", "StdAgeList":{ "StdAge":[ "Child", "Adult", "Older Adult" ] }, "StudyPopulation":"Patients admitted on intensive care units as well as general ward with AB bacteremia receiving antimicrobial therapy are eligible for this study.", "SamplingMethod":"Non-Probability Sample" }, "ContactsLocationsModule":{ "CentralContactList":{ "CentralContact":[ { "CentralContactName":"Aristine Cheng, MBBChir", "CentralContactRole":"Contact", "CentralContactPhone":"+886 975765607", "CentralContactEMail":"aristine@hotmail.com" },{ "CentralContactName":"Hsin-Yun Sun, MD", "CentralContactRole":"Contact", "CentralContactPhone":"+886 972651122", "CentralContactEMail":"hysun13@gmail.com" } ] }, "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Hsin-Yun Sun, MD", "OverallOfficialAffiliation":"National Taiwan University Hospital", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Yunlinn NTUH Branch", "LocationStatus":"Recruiting", "LocationCity":"Douliou", "LocationCountry":"Taiwan", "LocationContactList":{ "LocationContact":[ { "LocationContactName":"Chia-Ling Yang, MD", "LocationContactRole":"Contact", "LocationContactEMail":"y01944@ms1.ylh.gov.tw" } ] } },{ "LocationFacility":"Far Eastern Memorial Hospital", "LocationStatus":"Recruiting", "LocationCity":"New Taipei", "LocationZip":"220", "LocationCountry":"Taiwan", "LocationContactList":{ "LocationContact":[ { "LocationContactName":"Aristine Cheng, MD", "LocationContactRole":"Contact", "LocationContactEMail":"aristine@hotmail.com" } ] } },{ "LocationFacility":"National Taiwan University Hospital", "LocationStatus":"Recruiting", "LocationCity":"Taipei", "LocationZip":"100", "LocationCountry":"Taiwan", "LocationContactList":{ "LocationContact":[ { "LocationContactName":"Hsin-Yun Sun, MD", "LocationContactRole":"Contact", "LocationContactPhone":"+886 97265112", "LocationContactEMail":"hysun13@gmail.com" } ] } } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000016470", "ConditionMeshTerm":"Bacteremia" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000001424", "ConditionAncestorTerm":"Bacterial Infections" },{ "ConditionAncestorId":"D000018805", "ConditionAncestorTerm":"Sepsis" },{ "ConditionAncestorId":"D000007239", "ConditionAncestorTerm":"Infection" },{ "ConditionAncestorId":"D000018746", "ConditionAncestorTerm":"Systemic Inflammatory Response Syndrome" },{ "ConditionAncestorId":"D000007249", "ConditionAncestorTerm":"Inflammation" },{ "ConditionAncestorId":"D000010335", "ConditionAncestorTerm":"Pathologic Processes" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M8866", "ConditionBrowseLeafName":"Infection", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4951", "ConditionBrowseLeafName":"Communicable Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M17460", "ConditionBrowseLeafName":"Bacteremia", "ConditionBrowseLeafAsFound":"Bacteremia", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M3303", "ConditionBrowseLeafName":"Bacterial Infections", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M19448", "ConditionBrowseLeafName":"Sepsis", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M15452", "ConditionBrowseLeafName":"Toxemia", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M14938", "ConditionBrowseLeafName":"Syndrome", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M19402", "ConditionBrowseLeafName":"Systemic Inflammatory Response Syndrome", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8876", "ConditionBrowseLeafName":"Inflammation", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC01", "ConditionBrowseBranchName":"Bacterial and Fungal Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" } ] } } } } } }