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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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00489138
First Posted: June 21, 2007
Last Update Posted: February 25, 2014
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.
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
June 20, 2007
June 21, 2007
February 25, 2014
April 2007
April 2009   (Final data collection date for primary outcome measure)
assess the tissular and plasma kinetics of ertapenem [ Time Frame: 24 months ]
Not Provided
Complete list of historical versions of study NCT00489138 on ClinicalTrials.gov Archive Site
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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
Not Provided

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).

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
To Assess the Tissular and Plasma Kinetics of Ertapenem
Drug: Ertapenem
1g a day by drip of 30 min
  • Experimental: 1
    Noradrenalin infusion
    Intervention: Drug: Ertapenem
  • No Intervention: 2
    No adrenalin infusion
Boyadjiev I, Boulamery A, Simon N, Martin C, Bruguerolle B, Leone M. Penetration of ertapenem into muscle measured by in vivo microdialysis in mechanically ventilated patients. Antimicrob Agents Chemother. 2011 Jul;55(7):3573-5. doi: 10.1128/AAC.00180-11. Epub 2011 May 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
9
April 2009
April 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 years and more
  • negative pregnancy test
  • HIV/HBV, HCV negative tests
  • Mechanical ventilation with pneumonia or intraabdominal infection requiring ertapenem

Exclusion Criteria:

  • refractory septic shock requiring use of additional catecholamines
  • patients with positives tests for HIV, HBV, HCV
  • pregnant females
  • allergic insufficiency
  • hemodiafiltration
  • contraindication to microdialysis catheter set-up
  • severe arteritis of lower extremities
  • treatment with vasodilatators
  • prior history of aorto-iliac shunt
  • involvement in a clinical trial in the last three months
  • exclusion from national records
  • non affiliated to "securité sociale"
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00489138
2006/24
Not Provided
Not Provided
Not Provided
Assistance Publique Hopitaux De Marseille
Assistance Publique Hopitaux De Marseille
Not Provided
Principal Investigator: Ioanna BOYADJIEV, PH Assistance Publique Hôpitaux de Marseille
Assistance Publique Hopitaux De Marseille
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP