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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:
Information provided by:
Poitiers University Hospital
ClinicalTrials.gov Identifier:
NCT01061047
First received: January 29, 2010
Last updated: August 28, 2012
Last verified: January 2010
History of Changes
  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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01061047

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

No publications provided

ClinicalTrials.gov Identifier: NCT01061047     History of Changes
Other Study ID Numbers: ERTAMUSCLE
Study First Received: January 29, 2010
Last Updated: August 28, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on May 16, 2013