Pharmacokinetic of Doripenem and Piperacillin/Tazobactam in More Than 120 kg Critically Ill Patients
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Septic Shock |
Drug: Doripenem or Piperacillin/Tazobactam |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pharmacokinetic of Doripenem and Piperacillin/Tazobactam in More Than 120 kg Critically Ill Patients |
- Time over MIC (calculated with the E-test) in overweight and non overweight critically ill patients [ Time Frame: up to Day 8 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: No overweight patient
Patient with weight less than or equal to 120kg
|
Drug: Doripenem or Piperacillin/Tazobactam
This arm is composed of 20 no overweight patients, Antibiotic (Doripenem or Piperacillin/Tazobactam) is chosen by the intensivist in charge of the case:
Other Name: no overweight patients pharmacokinetics
|
|
Experimental: Overweight patients
Patient with weight more than 120kg
|
Drug: Doripenem or Piperacillin/Tazobactam
This arm is composed of 20 overweight patients, Antibiotic (Doripenem or Piperacillin/Tazobactam) is chosen by the intensivist in charge of the case:
Other Name: overweight patients pharmacokinetics
|
Detailed Description:
N=40 patients divided in 4*10 patients (10 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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 treament 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
Spécific to overweight patients: Weight > 120kg
Spécific to no overweight patients: Weight less than or equal to 120kg
Exclusion Criteria:
- Pregnant women
- Under age patient mineur
- Patient protected by law
- Known allergie to study's antibiotics
Contacts and Locations| Contact: Boris BJ JUNG, MD | +33 4 67 33 72 71 | b-jung@chu-montpellier.fr |
| France | |
| Saint Eloi Intensive Care Unit - Montpellier University Hospital | Recruiting |
| Montpellier, France, 34295 | |
| Contact: Boris BJ JUNG, MD +33 4 67 33 72 71 b-jung@chu-montpellier.fr | |
| Principal Investigator: | Boris BJ JUNG, MD | Saint Eloi Hospital - Montpellier University Hospital |
More Information
No publications provided
| Responsible Party: | University Hospital, Montpellier |
| ClinicalTrials.gov Identifier: | NCT01517815 History of Changes |
| Other Study ID Numbers: | UF 8739 |
| Study First Received: | January 11, 2012 |
| Last Updated: | May 14, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: Committee for the Protection of Personnes |
Keywords provided by University Hospital, Montpellier:
|
Septic shock overweight critically ill |
pharmacokinetic doripenem piperacillin-tazobactam |
Additional relevant MeSH terms:
|
Critical Illness Shock Shock, Septic Disease Attributes Pathologic Processes Sepsis Infection Systemic Inflammatory Response Syndrome Inflammation Piperacillin |
Penicillanic Acid Piperacillin-tazobactam combination product Tazobactam Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013