- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01517815
Pharmacokinetic of Doripenem and Piperacillin/Tazobactam in More Than 120 kg Critically Ill Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
N=52 patients divided in 4*13 patients (13 per antibiotic and per group, overweight or non overweight).
Overweight 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.
Piperacillin/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.
Usual plasma and urine samples for urea, creatinine, electrolytes, platelets and bilirubin each 24h.
Microbiology: bacterial identification and MIC measurement with E-test
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Montpellier, France, 34295
- Saint Eloi Intensive Care Unit - Montpellier University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
General:
- Patients 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)
- Patient requiring a treatment by study's antibiotics
- Informed consent signed
- Patient must be affiliated or beneficiary of a social medical insurance
- Participation of patient to the trial must be noted in the medical file
Specific to overweight patients: Weight > 120kg
Specific to no overweight patients: Weight less than or equal to 120kg
Exclusion Criteria:
- Pregnant women
- Under age patient minor
- Patient protected by law
- Known allergy to study's antibiotics
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: No overweight patient
Patient with weight less than or equal to 120kg
|
This arm is composed of 26 no overweight patients, Antibiotic (Doripenem or Piperacillin/Tazobactam) is chosen by the intensivist in charge of the case:
Other Names:
This arm is composed of 26 overweight patients, Antibiotic (Doripenem or Piperacillin/Tazobactam) is chosen by the intensivist in charge of the case:
Other Names:
|
EXPERIMENTAL: Overweight patients
Patient with weight more than 120kg
|
This arm is composed of 26 no overweight patients, Antibiotic (Doripenem or Piperacillin/Tazobactam) is chosen by the intensivist in charge of the case:
Other Names:
This arm is composed of 26 overweight patients, Antibiotic (Doripenem or Piperacillin/Tazobactam) is chosen by the intensivist in charge of the case:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time over MIC (calculated with the E-test) in overweight and non overweight critically ill patients
Time Frame: up to Day 8
|
up to Day 8
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Boris BJ JUNG, MD, Saint Eloi Hospital - Montpellier University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Systemic Inflammatory Response Syndrome
- Inflammation
- Disease Attributes
- Shock
- Sepsis
- Shock, Septic
- Critical Illness
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Bacterial Agents
- beta-Lactamase Inhibitors
- Piperacillin
- Tazobactam
- Piperacillin, Tazobactam Drug Combination
- Doripenem
Other Study ID Numbers
- 8739 (Other Identifier: CTEP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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