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
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00489138|
Recruitment Status : Terminated
First Posted : June 21, 2007
Last Update Posted : February 25, 2014
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).
|Condition or disease||Intervention/treatment||Phase|
|To Assess the Tissular and Plasma Kinetics of Ertapenem||Drug: Ertapenem||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||April 2007|
|Primary Completion Date :||April 2009|
|Study Completion Date :||April 2009|
1g a day by drip of 30 min
No Intervention: 2
No adrenalin infusion
- assess the tissular and plasma kinetics of ertapenem [ Time Frame: 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00489138
|Département d'Anesthésie-Réanimation - CHU NORD|
|Marseille, France, 13915|
|Principal Investigator:||Ioanna BOYADJIEV, PH||Assistance Publique Hôpitaux de Marseille|