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

Healthy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01061047
• Other study ID #: ERTAMUSCLE
• Status: Completed
• Phase: Phase 1
• First received: January 29, 2010
• Last updated: August 28, 2012

Study information

• Verified date: January 2010
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Ertapeneme

Locations

Country	Name	City	State
France	Poitiers University Hospital - 2 rue de la Milétrie - Réanimation chirugicale	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France,