{
  "FullStudy":{
    "Rank":217712,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01517815",
          "OrgStudyIdInfo":{
            "OrgStudyId":"8739"
          },
          "Organization":{
            "OrgFullName":"University Hospital, Montpellier",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Pharmacokinetic of Doripenem and Piperacillin/Tazobactam in More Than 120 kg Critically Ill Patients",
          "OfficialTitle":"Pharmacokinetic of Doripenem and Piperacillin/Tazobactam in More Than 120 kg Critically Ill Patients"
        },
        "StatusModule":{
          "StatusVerifiedDate":"November 2013",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"February 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"June 2013",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"June 2013",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 11, 2012",
          "StudyFirstSubmitQCDate":"January 24, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 25, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"November 28, 2016",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"November 29, 2016",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"University Hospital, Montpellier",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"Overweight patients are susceptible to develop acute complications when they are admitted in an Intensive Care Unit (ICU). Severe infection can be associated with cardiovascular failure ('shock\") and is associated with 35-50% mortality. One of the key issue to cure infection is to administer antibiotics. However, under dosing antibiotic is one of the main reason that explain treatment failure. There are very few data concerning particularities of antibiotic dosing in critically ill, overweight, patients. The aim of the present study is to describe the pharmacokinetic of two main antibiotics (doripenem and piperacillin/Tazobactam) in both overweight and non overweight critically ill patients presenting a septic shock. The investigators hypothesis is that usual dose for those antibiotic may be accurate in non overweight patients but is not in overweight patients.",
          "DetailedDescription":"N=52 patients divided in 4*13 patients (13 per antibiotic and per group, overweight or non overweight).\n\nOverweight is defined by a weight over 120kg. Antibiotic chosen by the intensivist in charge of the case. Doripenem 1g/8h with a 4h IV infusion whatever the patient's weight. Piperacillin/Tazobactam 4g IV (1h) and then 16g/24h IV continuously whatever the patient's weight.\n\nPiperacillin/Tazobactam plasma dosage: after the first dose and then every 12h. Doripenem plasma dosage: after the first dose and then twice a day, at peak and residual value.\n\nUsual plasma and urine samples for urea, creatinine, electrolytes, platelets and bilirubin each 24h.\n\nMicrobiology: bacterial identification and MIC measurement with E-test"
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Septic Shock"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Septic shock",
              "overweight",
              "critically ill",
              "pharmacokinetic",
              "doripenem",
              "piperacillin-tazobactam"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Non-Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"50",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"No overweight patient",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Patient with weight less than or equal to 120kg",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Doripenem or Piperacillin/Tazobactam"
                  ]
                }
              },{
                "ArmGroupLabel":"Overweight patients",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Patient with weight more than 120kg",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Doripenem or Piperacillin/Tazobactam"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"Doripenem or Piperacillin/Tazobactam",
                "InterventionDescription":"This arm is composed of 26 no overweight patients, Antibiotic (Doripenem or Piperacillin/Tazobactam) is chosen by the intensivist in charge of the case:\n\nin 13 no overweight patients, Pipéracilline/tazobactam will be administered in 4g IV (1h) and then 16g/24h IV continuously. Piperacillin/Tazobactam plasma dosage: after the first dose and then every 12h.\nin 13 patients no overweight: doripénème will be administered in 1g/8h with a 4h IV infusion. Doripenem plasma dosage: after the first dose and then twice a day, at peak and residual value.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "No overweight patient"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "no overweight patients pharmacokinetics"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"Doripenem or Piperacillin/Tazobactam",
                "InterventionDescription":"This arm is composed of 26 overweight patients, Antibiotic (Doripenem or Piperacillin/Tazobactam) is chosen by the intensivist in charge of the case:\n\nin 13 overweight patients, Pipéracilline/tazobactam will be administered in 4g IV (1h) and then 16g/24h IV continuously. Piperacillin/Tazobactam plasma dosage: after the first dose and then every 12h.\nin 13 patients overweight: doripénème will be administered in 1g/8h with a 4h IV infusion. Doripenem plasma dosage: after the first dose and then twice a day, at peak and residual value.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Overweight patients"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "overweight patients pharmacokinetics"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Time over MIC (calculated with the E-test) in overweight and non overweight critically ill patients",
                "PrimaryOutcomeTimeFrame":"up to Day 8"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nGeneral:\n\nPatients in severe sepsis or septic shock defined by Bone criteria (proved or very suspected infection with organ impairment and/or need of vasopressive agent to keep a mean arterial pressure more than 65mmHg)\nPatient requiring a treatment by study's antibiotics\nInformed consent signed\nPatient must be affiliated or beneficiary of a social medical insurance\nParticipation of patient to the trial must be noted in the medical file\n\nSpecific to overweight patients: Weight > 120kg\n\nSpecific to no overweight patients: Weight less than or equal to 120kg\n\nExclusion Criteria:\n\nPregnant women\nUnder age patient minor\nPatient protected by law\nKnown allergy to study's antibiotics",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Boris BJ JUNG, MD",
                "OverallOfficialAffiliation":"Saint Eloi Hospital - Montpellier University Hospital",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Saint Eloi Intensive Care Unit - Montpellier University Hospital",
                "LocationCity":"Montpellier",
                "LocationZip":"34295",
                "LocationCountry":"France"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000078142",
                "InterventionMeshTerm":"Tazobactam"
              },{
                "InterventionMeshId":"D000010878",
                "InterventionMeshTerm":"Piperacillin"
              },{
                "InterventionMeshId":"D000077725",
                "InterventionMeshTerm":"Piperacillin, Tazobactam Drug Combination"
              },{
                "InterventionMeshId":"D000077726",
                "InterventionMeshTerm":"Doripenem"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000000900",
                "InterventionAncestorTerm":"Anti-Bacterial Agents"
              },{
                "InterventionAncestorId":"D000000890",
                "InterventionAncestorTerm":"Anti-Infective Agents"
              },{
                "InterventionAncestorId":"D000065093",
                "InterventionAncestorTerm":"beta-Lactamase Inhibitors"
              },{
                "InterventionAncestorId":"D000004791",
                "InterventionAncestorTerm":"Enzyme Inhibitors"
              },{
                "InterventionAncestorId":"D000045504",
                "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M1938",
                "InterventionBrowseLeafName":"Tazobactam",
                "InterventionBrowseLeafAsFound":"Tazobactam",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M12355",
                "InterventionBrowseLeafName":"Piperacillin",
                "InterventionBrowseLeafAsFound":"Piperacillin",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M1886",
                "InterventionBrowseLeafName":"Doripenem",
                "InterventionBrowseLeafAsFound":"Doripenem",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M1885",
                "InterventionBrowseLeafName":"Piperacillin, Tazobactam Drug Combination",
                "InterventionBrowseLeafAsFound":"Piperacillin/Tazobactam",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M2803",
                "InterventionBrowseLeafName":"Anti-Bacterial Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M2795",
                "InterventionBrowseLeafName":"Anti-Infective Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M29037",
                "InterventionBrowseLeafName":"beta-Lactamase Inhibitors",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"Infe",
                "InterventionBrowseBranchName":"Anti-Infective Agents"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              }
            ]
          }
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000012772",
                "ConditionMeshTerm":"Shock, Septic"
              },{
                "ConditionMeshId":"D000016638",
                "ConditionMeshTerm":"Critical Illness"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000012769",
                "ConditionAncestorTerm":"Shock"
              },{
                "ConditionAncestorId":"D000010335",
                "ConditionAncestorTerm":"Pathologic Processes"
              },{
                "ConditionAncestorId":"D000020969",
                "ConditionAncestorTerm":"Disease Attributes"
              },{
                "ConditionAncestorId":"D000018805",
                "ConditionAncestorTerm":"Sepsis"
              },{
                "ConditionAncestorId":"D000007239",
                "ConditionAncestorTerm":"Infection"
              },{
                "ConditionAncestorId":"D000018746",
                "ConditionAncestorTerm":"Systemic Inflammatory Response Syndrome"
              },{
                "ConditionAncestorId":"D000007249",
                "ConditionAncestorTerm":"Inflammation"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M17593",
                "ConditionBrowseLeafName":"Critical Illness",
                "ConditionBrowseLeafAsFound":"Critically Ill",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M14160",
                "ConditionBrowseLeafName":"Shock",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M14163",
                "ConditionBrowseLeafName":"Shock, Septic",
                "ConditionBrowseLeafAsFound":"Septic Shock",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M24773",
                "ConditionBrowseLeafName":"Overweight",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M21284",
                "ConditionBrowseLeafName":"Disease Attributes",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M19448",
                "ConditionBrowseLeafName":"Sepsis",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M15452",
                "ConditionBrowseLeafName":"Toxemia",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M8866",
                "ConditionBrowseLeafName":"Infection",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M4951",
                "ConditionBrowseLeafName":"Communicable Diseases",
                "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":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC01",
                "ConditionBrowseBranchName":"Bacterial and Fungal Diseases"
              }
            ]
          }
        }
      }
    }
  }
}