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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Keywords

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patients infected with a bacteria sensible to ertapeneme

Interventions

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Ertapeneme

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Locations

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

Poitiers, , France

Site Status

Countries

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France

Other Identifiers

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ERTAMUSCLE

Identifier Type: -

Identifier Source: org_study_id