Pharmacokinetics Ertapenem Burns

Sponsor

Nantes University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01497990

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Burn Patients	Drug: Ertapenem	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Sep 1, 2011

Actual Study Completion Date :

Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.

Arm

Intervention/Treatment

Experimental: 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.

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.

Outcome Measures

Primary Outcome Measures

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. [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]
Current study the pharmacokinetics (Cmax, Vz, ClP , ClR , ClNR , fe, T1/2beta, AUC 0 - alpha) in a population of burn patients.

Secondary Outcome Measures

Time between injection and observation of a serum concentration less than the critical concentration below [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]
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.
Time needed between injections in order to obtain a concentration greater than the critical concentration below for the duration of time between two injections [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]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nantes University Hospital	Nantes		France	44000

Sponsors and Collaborators

Nantes University Hospital

Investigators

Study Chair: Ronan LE FLOCH, PH, Nantes University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nantes University Hospital

ClinicalTrials.gov Identifier:

NCT01497990

Other Study ID Numbers:

09/3-W

First Posted:

Dec 23, 2011

Last Update Posted:

Nov 4, 2012

Last Verified:

Nov 1, 2012

Keywords provided by Nantes University Hospital

Burns

Ertapenem

Pharmacokinetics

Additional relevant MeSH terms:

Burns

Ertapenem

Study Results

No Results Posted as of Nov 4, 2012