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NCT01061047
Comparison of Ertapenem Distribution in the Muscle of Six Healthy Volunteers and Six Critically Ill Patients by Microdialysis
Phase 1 trial testing Ertapeneme in Healthy. Completed.
Quick facts
| Lead sponsor | Poitiers University Hospital |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Sites | 1 location across France |
Drugs / interventions tested
- Ertapeneme — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Poitiers University Hospital
Who can join
Adults 18 to 80, any sex, with Healthy. Healthy volunteers can join.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01061047
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01061047 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Poitiers University Hospital
- Last refreshed: 28 August 2012
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01061047.
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