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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014