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

P

Poitiers University Hospital

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Ertapeneme

Study type

Interventional

Funder types

Other

Identifiers

NCT01061047
ERTAMUSCLE

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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