Skip to content

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01061047
Enrollment
Unknown
Registered
2010-02-02
Start date
Unknown
Completion date
Unknown
Last updated
2012-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

patients infected with a bacteria sensible to ertapeneme

Brief 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.

Interventions

DRUGErtapeneme

Sponsors

Poitiers University Hospital
Lead SponsorOTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026