NCT01061047

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 2, 2010

Completed
Last Updated

August 29, 2012

Status Verified

January 1, 2010

First QC Date

January 29, 2010

Last Update Submit

August 28, 2012

Conditions

Healthy

Keywords

patients infected with a bacteria sensible to ertapeneme

Interventions

ErtapenemeDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: from 18 to 80 years
  • Patients with infection due to ertapenem susceptible bacteria.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Poitiers, 86021, France

Location

Study Design

Study Type
interventional
Phase
phase 1
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 29, 2010

First Posted

February 2, 2010

Last Updated

August 29, 2012

Record last verified: 2010-01

Locations

FR(1)