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Pharmacokinetic of Doripenem and Piperacillin/Tazobactam in More Than 120 kg Critically Ill Patients

Information source: University Hospital, Montpellier
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Septic Shock

Intervention: Doripenem or Piperacillin/Tazobactam (Drug); Doripenem or Piperacillin/Tazobactam (Drug)

Phase: N/A

Status: Completed

Sponsored by: University Hospital, Montpellier

Official(s) and/or principal investigator(s):
Boris BJ JUNG, MD, Principal Investigator, Affiliation: Saint Eloi Hospital - Montpellier University Hospital


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.

Clinical Details

Official title: Pharmacokinetic of Doripenem and Piperacillin/Tazobactam in More Than 120 kg Critically Ill Patients

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Time over MIC (calculated with the E-test) in overweight and non overweight critically ill patients

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


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Saint Eloi Intensive Care Unit - Montpellier University Hospital, Montpellier 34295, France
Additional Information

Starting date: February 2012
Last updated: November 5, 2013

Page last updated: August 23, 2015

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