Clinical Trials Directory

Trials / Completed

CompletedNCT01061047

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

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
Sponsor
Poitiers University Hospital · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGErtapeneme

Timeline

First posted
2010-02-02
Last updated
2012-08-29

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT01061047. Inclusion in this directory is not an endorsement.