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

Information source: Poitiers University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Ertapeneme (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Poitiers University Hospital


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.

Clinical Details

Study design: N/A


Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.


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

Locations and Contacts

Poitiers University Hospital - 2 rue de la Milétrie - Réanimation chirugicale, Poitiers 86021, France
Additional Information

Last updated: August 28, 2012

Page last updated: August 23, 2015

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