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

NCT ID: NCT01517815

Last Updated: 2016-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2013-06-30

Brief 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.

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

Conditions

Septic Shock

Keywords

Septic shock; overweight; critically ill; pharmacokinetic; doripenem; piperacillin-tazobactam

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

No overweight patient

Patient with weight less than or equal to 120kg

Group Type: EXPERIMENTAL

Doripenem or Piperacillin/Tazobactam

Intervention Type: DRUG

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.

Overweight patients

Patient with weight more than 120kg

Group Type: EXPERIMENTAL

Doripenem or Piperacillin/Tazobactam

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

no overweight patients pharmacokinetics; overweight patients pharmacokinetics

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boris BJ JUNG, MD

Role: PRINCIPAL_INVESTIGATOR

Saint Eloi Hospital - Montpellier University Hospital

Locations

Saint Eloi Intensive Care Unit - Montpellier University Hospital

Montpellier, , France

Countries

France

Other Identifiers

8739

Identifier Type: -

Identifier Source: org_study_id