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

NCT01517815 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2016-11-29

No results posted yet for this study

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.

Conditions

  • Septic Shock

Interventions

DRUG

Doripenem or Piperacillin/Tazobactam

This arm is composed of 26 no overweight patients, Antibiotic (Doripenem or Piperacillin/Tazobactam) is chosen by the intensivist in charge of the case: * in 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. * in 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.

DRUG

Doripenem or Piperacillin/Tazobactam

This arm is composed of 26 overweight patients, Antibiotic (Doripenem or Piperacillin/Tazobactam) is chosen by the intensivist in charge of the case: * in 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. * in 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.

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Boris BJ JUNG, MD · Saint Eloi Hospital - Montpellier University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01517815 on ClinicalTrials.gov