Comparison of Ertapenem Distribution in the Muscle of Six Healthy Volunteers and Six Critically Ill Patients by Microdialysis
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Poitiers University Hospital
- Locations
- 1
Study Overview
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.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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