A Phase 4 interventional study of Ertapenem in Burn Patients, sponsored by Nantes University Hospital. Completed at 1 site in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Nantes University Hospital · Phase 4, Interventional, and Treatment
This study will examine the pharmacokinetics of ertapenem in ventilated badly (> 30% SCT) burn patients.
719 studies on the registry are indexed under Burns; 145 are open to participants now.
This study's enrollment of 8 is below the median of 40 across 524 interventional studies indexed under Burns.
Browse Burns studies →Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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.
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
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.
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
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.
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
This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.
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Nantes University Hospital