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

To Assess the Tissular and Plasma Kinetics of Ertapenem Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00489138
• Other study ID #: 2006/24
• Status: Terminated
• Phase: Phase 4
• First received: June 20, 2007
• Last updated: February 24, 2014
• Start date: April 2007
• Est. completion date: April 2009

Study information

• Verified date: February 2014
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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"

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• To Assess the Tissular and Plasma Kinetics of Ertapenem

Intervention

Drug:
• Ertapenem
1g a day by drip of 30 min

Locations

Country	Name	City	State
France	Département d'Anesthésie-Réanimation - CHU NORD	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assess the tissular and plasma kinetics of ertapenem		24 months	No