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Pharmacokinetics Ertapenem Burns

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01497990
First received: December 15, 2011
Last updated: November 2, 2012
Last verified: November 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Burn Patients
 Drug: Ertapenem
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacokinetics of Ertapenem When Used in Empiric Treatment in Burn Patients. Prospective Open Label Study.

Resource links provided by NLM:

MedlinePlus related topics: Burns
U.S. FDA Resources

Further study details as provided by Nantes University Hospital:

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. [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 8
Study Start Date: January 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01497990

Locations
France
Nantes University Hospital
Nantes, France, 44000
Sponsors and Collaborators
Nantes University Hospital
Investigators
Study Chair: Ronan LE FLOCH, PH Nantes University Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01497990     History of Changes
Other Study ID Numbers: 09/3-W
Study First Received: December 15, 2011
Last Updated: November 2, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Nantes University Hospital:
Burns
Ertapenem
Pharmacokinetics

Additional relevant MeSH terms:
Burns
Wounds and Injuries
Ertapenem
Anti-Bacterial Agents
 Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013