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Pharmacokinetics Ertapenem Burns

Information source: Nantes University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Burn Patients

Intervention: Ertapenem (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Nantes University Hospital

Official(s) and/or principal investigator(s):
Ronan LE FLOCH, PH, Study Chair, Affiliation: Nantes University Hospital


This study will examine the pharmacokinetics of ertapenem in ventilated badly (> 30% SCT) burn patients.

Clinical Details

Official title: Pharmacokinetics of Ertapenem When Used in Empiric Treatment in Burn Patients. Prospective Open Label Study.

Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Measurement of serum concentrations of total ertapenem from the second injection in order to calculate Cmax, Vz, ClP , ClR , ClNR , fe, T1/2b et AUC0 - alpha.

Secondary outcome:

Time between injection and observation of a serum concentration less than the critical concentration below

Time needed between injections in order to obtain a concentration greater than the critical concentration below for the duration of time between two injections


Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.


Inclusion Criteria:

- Patients aged 18 to 70 years

- Burned on 30 to 60% of their body surface

- Mechanical ventilation

- Hospitalized in the intensive care unit of Nantes University Hospital for less than 8


- Which the family gave consent

- insured

Exclusion Criteria:

- Patients whose family refused to sign the consent for participation.

- Patients allergic to beta lactam

- Patients with renal failure with creatinine clearance <80 ml. mn-1

- Pregnant women

- Persons protected by the law

Locations and Contacts

Nantes University Hospital, Nantes 44000, France
Additional Information

Starting date: January 2010
Last updated: November 2, 2012

Page last updated: August 23, 2015

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