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

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.

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Key information

Conditions

Healthy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Poitiers University Hospital - 2 rue de la Milétrie - Réanimation chirugicale

Poitiers, 86021, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ertapeneme

Drug

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Important dates

First posted: Feb 2, 2010
Registry last updated: Aug 29, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed