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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

Information source: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: To Assess the Tissular and Plasma Kinetics of Ertapenem

Intervention: Ertapenem (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Assistance Publique Hopitaux De Marseille

Official(s) and/or principal investigator(s):
Ioanna BOYADJIEV, PH, Principal Investigator, Affiliation: Assistance Publique Hôpitaux de Marseille


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).

Clinical Details

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

Primary outcome: assess the tissular and plasma kinetics of ertapenem


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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"

Locations and Contacts

Département d'Anesthésie-Réanimation - CHU NORD, Marseille 13915, France
Additional Information

Starting date: April 2007
Last updated: February 24, 2014

Page last updated: August 23, 2015

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