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Completed

NCT Number: NCT01497990

Pharmacokinetics Ertapenem Burns

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

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Key information

Conditions

Burn Patients Burns Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Nantes University Hospital

Nantes, 44000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ertapenem

Drug

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

Primary outcomes

  1. 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

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

Secondary outcomes

  1. 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

    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.

  2. 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

    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.

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 23, 2011
Registry last updated
Nov 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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