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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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 25, 2014