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. Identifier: NCT00489138
Recruitment Status : Terminated
First Posted : June 21, 2007
Last Update Posted : February 25, 2014
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

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).

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : April 2007
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Noradrenalin infusion
Drug: Ertapenem
1g a day by drip of 30 min

No Intervention: 2
No adrenalin infusion

Primary Outcome Measures :
  1. assess the tissular and plasma kinetics of ertapenem [ Time Frame: 24 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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"

Information from the National Library of Medicine

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 identifier (NCT number): NCT00489138

Département d'Anesthésie-Réanimation - CHU NORD
Marseille, France, 13915
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Principal Investigator: Ioanna BOYADJIEV, PH Assistance Publique Hôpitaux de Marseille

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Assistance Publique Hopitaux De Marseille Identifier: NCT00489138     History of Changes
Other Study ID Numbers: 2006/24
First Posted: June 21, 2007    Key Record Dates
Last Update Posted: February 25, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
Anti-Bacterial Agents
Anti-Infective Agents