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
Summary
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 belowTime needed between injections in order to obtain a concentration greater than the critical concentration below for the duration of time between two injections
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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
days.
- 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
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