Pharmacokinetics Ertapenem Burns

Study Overview
=================
Brief Summary
-----------------
This study will examine the pharmacokinetics of ertapenem in ventilated badly (> 30% SCT) burn patients.

Official Title
-----------------
Pharmacokinetics of Ertapenem When Used in Empiric Treatment in Burn Patients. Prospective Open Label Study.

Conditions
-----------------
Burn Patients

Intervention / Treatment
-----------------
* Drug: Ertapenem


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 18 to 70 years Burned on 30 to 60% of their body surface Mechanical ventilation Hospitalized in the intensive care unit of Nantes University Hospital for less than 8 days. Which the family gave consent insured Exclusion Criteria: Patients whose family refused to sign the consent for participation. Patients allergic to beta lactam Patients with renal failure with creatinine clearance <80 ml.mn-1 Pregnant women Persons protected by the law

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ertapenem<br>The patient received two injections of ertapenem, at a dose of 1g.j-1 by intravenous injection of 30 minutes, separated by 24 h. | Drug: Ertapenem<br>* The patient received two injections of ertapenem, at a dose of 1g.j-1 by intravenous injection of 30 minutes, separated by 24 h.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of serum concentrations of total ertapenem from the second injection in order to calculate Cmax, Vz, ClP , ClR , ClNR , fe, T1/2b et AUC0 - alpha. | Current study the pharmacokinetics (Cmax, Vz, ClP , ClR , ClNR , fe, T1/2beta, AUC 0 - alpha) in a population of burn patients. | Blood samples 5 min after the end of the second injection and 1 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h after the start of the second injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time between injection and observation of a serum concentration less than the critical concentration below | Check that the injection of 1 g ertapenem achieves a serum concentration above the critical concentration of bacteria usually isolated in cases of early infection for more than 40% of the time between two injections (t / MIC> 40 %), this ratio being one of the criteria predictive of efficacy of beta-lactam antibiotics. | Blood samples 5 min after the end of the second injection and 1 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h after the start of the second injection | 
| Time needed between injections in order to obtain a concentration greater than the critical concentration below for the duration of time between two injections | Study when two injections of ertapenem serum concentrations fall below the critical concentrations of bacteria usually isolated in cases of early infection, if they become. | Blood samples 5 min after the end of the second injection and 1 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h after the start of the second injection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ertapenem, Burns, Pharmacokinetics