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:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT00489138
First received: June 20, 2007
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
To Assess the Tissular and Plasma Kinetics of Ertapenem
Drug: Ertapenem
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • assess the tissular and plasma kinetics of ertapenem [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: April 2007
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Noradrenalin infusion
Drug: Ertapenem
1g a day by drip of 30 min
No Intervention: 2
No adrenalin infusion

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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"
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00489138

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

No publications provided by Assistance Publique Hopitaux De Marseille

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT00489138     History of Changes
Other Study ID Numbers: 2006/24
Study First Received: June 20, 2007
Last Updated: February 24, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Ertapenem
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014