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
| Type | Name | Description |
|---|---|---|
| DRUG | Ertapeneme |
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.