drugset / Trial / NCT00489138

Prospective, Open-label Study of Pharmacokinetics of Ertapenem in the Muscle Using Microdialysis in Mechanically Ventilated Intensive Care Unit Patients, Treated or Not by Norepinephrine

NCT00489138

Phase 4 Terminated 9 enrolled Assistance Publique Hopitaux De Marseille
RandomizedParallel-groupOpen-labelTreatment

Summary

Goal of study: To assess the tissular and plasma kinetics of ertapenem; To determine the optimal dosages in the patients according to norepinephrine administration: * to assess muscular diffusion of free form of ertapenem after administration to mechanically ventilated patients requiring such a treatment. The patients are included in the groups "with norepinephrine" or "without norepinephrine" according to their hemodynamic status. * to assess the plasma pharmacokinetics of ertapenem in mechanically ventilated patients treated or not by norepinephrine. Open-label, prospective study performed in a single ICU (16 beds) of a tertiary hospital (700 beds).

Timeline

Start
2007-04
Primary completion
2009-04
Completion
2009-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Ertapenem Small molecule 1 g Intravenous

Indications

No indication recorded.