Pharmacokinetics Ertapenem Burns

Burn Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01497990
• Other study ID #: 09/3-W
• Status: Completed
• Phase: Phase 4
• First received: December 15, 2011
• Last updated: November 2, 2012
• Start date: January 2010
• Est. completion date: September 2011

Study information

• Verified date: November 2012
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Burn Patients
• Burns

Intervention

Drug:
• Ertapenem
The patient received two injections of ertapenem, at a dose of 1g.j-1 by intravenous injection of 30 minutes, separated by 24 h.

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Current study the pharmacokinetics (Cmax, Vz, ClP , ClR , ClNR , fe, T1/2beta, AUC 0 - alpha) in a population of burn patients.	Blood samples 5 min after the end of the second injection and 1 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h after the start of the second injection	No
Secondary	Time between injection and observation of a serum concentration less than the critical concentration below	Check that the injection of 1 g ertapenem achieves a serum concentration above the critical concentration of bacteria usually isolated in cases of early infection for more than 40% of the time between two injections (t / MIC> 40 %), this ratio being one of the criteria predictive of efficacy of beta-lactam antibiotics.	Blood samples 5 min after the end of the second injection and 1 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h after the start of the second injection	No
Secondary	Time needed between injections in order to obtain a concentration greater than the critical concentration below for the duration of time between two injections	Study when two injections of ertapenem serum concentrations fall below the critical concentrations of bacteria usually isolated in cases of early infection, if they become.	Blood samples 5 min after the end of the second injection and 1 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h after the start of the second injection	No