Viewing Study NCT00489138



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Last Modification Date: 2024-10-26 @ 9:33 AM
Study NCT ID: NCT00489138
Status: TERMINATED
Last Update Posted: 2014-02-25
First Post: 2007-06-20

Brief Title: 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
Sponsor: Assistance Publique Hopitaux De Marseille
Organization: Assistance Publique Hopitaux De Marseille

Study Overview

Official Title: None
Status: TERMINATED
Status Verified Date: 2014-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None