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