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

NCT01517815 | Completed

• 1 other identifier: 8739
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  up to Day 8

Study Arms (2)

No overweight patient

EXPERIMENTAL

Patient with weight less than or equal to 120kg

Drug: Doripenem or Piperacillin/Tazobactam

Overweight patients

EXPERIMENTAL

Patient with weight more than 120kg

Drug: Doripenem or Piperacillin/Tazobactam

Interventions

Doripenem or Piperacillin/Tazobactam 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.

Also known as: no overweight patients pharmacokinetics

No overweight patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant women
• Under age patient minor
• Patient protected by law
• Known allergy to study's antibiotics

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Saint Eloi Intensive Care Unit - Montpellier University Hospital

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Shock, Septic; Overweight; Critical Illness

Interventions

Doripenem; Piperacillin; Tazobactam

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Penicillanic Acid; Sulfones

Study Officials

• Boris BJ JUNG, MD

  Saint Eloi Hospital - Montpellier University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2012
• First Posted: January 25, 2012
• Study Start: February 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: November 29, 2016

Record last verified: 2013-11

Locations

FR (1)