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

February 24, 2014 updated by: Assistance Publique Hopitaux 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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Noradrenalin infusion
Drug: Ertapenem
1g a day by drip of 30 min
No Intervention: 2
No adrenalin infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
assess the tissular and plasma kinetics of ertapenem
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Investigators

  • Principal Investigator: Ioanna BOYADJIEV, PH, Assistance Publique Hôpitaux de Marseille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

June 20, 2007

First Submitted That Met QC Criteria

June 20, 2007

First Posted (Estimate)

June 21, 2007

Study Record Updates

Last Update Posted (Estimate)

February 25, 2014

Last Update Submitted That Met QC Criteria

February 24, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006/24

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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