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Comparison of Ertapenem Distribution in the Muscle of Six Healthy Volunteers and Six Critically Ill Patients by Microdialysis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01061047
First Posted: February 2, 2010
Last Update Posted: August 29, 2012
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.
Information provided by:
Poitiers University Hospital
  Purpose

Ertapenem is an antibiotic that is highly bound to plasma protein (> 95%). The effects of this high protein binding on tissue distribution of antibiotics have been few evaluated yet.

In this study, two groups of subjects will be compared: 6 healthy volunteers and 6 critically ill patients (patients with infection due to an Ertapenem susceptible bacteria). Indeed, these 2 populations show changes in binding capacity of drugs to plasma proteins due to a decrease of protidaemia and of the affinity of drugs to transport proteins.

It seems therefore important to clarify the consequences of a modification in protein binding on distribution of antibiotics. That's why we have decided to characterize tissue distribution of ertapenem in healthy volunteers and critically ill patients by assessing: free and total concentrations in plasma and free concentrations in muscle by microdialysis.


Condition Intervention Phase
Healthy Drug: Ertapeneme Phase 1

Study Type: Interventional

Further study details as provided by Poitiers University Hospital:

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age: from 18 to 80 years
  • Patients with infection due to ertapenem susceptible bacteria.

Exclusion Criteria:

  • Patients who received ertapenem within 7 days prior to inclusion
  • Known allergy to ertapenem or any excipients
  • Neutropenia < 500/mm3
  • Hemoglobin concentration < 9g/dl
  • Renal failure (creatinin clearance < 30ml/min/1.73m²)
  • Decompensated heart failure
  • Patients receiving vasopressor (adrenalin, noradrenalin), > 0.5µg/kg/min
  • Known hypersensitivity to Elma®
  • Positive pregnancy test or currently lactating
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01061047


Locations
France
Poitiers University Hospital - 2 rue de la Milétrie - Réanimation chirugicale
Poitiers, France, 86021
Sponsors and Collaborators
Poitiers University Hospital
  More Information

ClinicalTrials.gov Identifier: NCT01061047     History of Changes
Other Study ID Numbers: ERTAMUSCLE
First Submitted: January 29, 2010
First Posted: February 2, 2010
Last Update Posted: August 29, 2012
Last Verified: January 2010

Keywords provided by Poitiers University Hospital:
patients infected with a bacteria sensible to ertapeneme