Pharmacokinetics Ertapenem Burns

Phase 4

Completed

• Conditions: Burn Patients
• Interventions: Drug: Ertapenem

• Registration Number: NCT01497990
• Lead Sponsor: Nantes University Hospital

Brief Summary

This study will examine the pharmacokinetics of ertapenem in ventilated badly (\> 30% SCT) burn patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Study First Submitted: 2011-12-15
• Study First Submitted QC: 2011-12-22
• Study First Posted: 2011-12-23
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-02
• Last Update Posted: 2012-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ertapenem	Ertapenem	The patient received two injections of ertapenem, at a dose of 1g.j-1 by intravenous injection of 30 minutes, separated by 24 h.

Primary Outcome Measures

Name	Time	Method
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.	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	Current study the pharmacokinetics (Cmax, Vz, ClP , ClR , ClNR , fe, T1/2beta, AUC 0 - alpha) in a population of burn patients.

Secondary Outcome Measures

Name	Time	Method
Time between injection and observation of a serum concentration less than the critical concentration below	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	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.
Time needed between injections in order to obtain a concentration greater than the critical concentration below for the duration of time between two injections	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	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.

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, France