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
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.
Clinical Details
Study design: N/A
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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
|
