Assessment of the Optimal Dosing of Piperacillin-tazobactam in Intensive Care Unit Patients: Extended Versus Continuous Infusion
|ClinicalTrials.gov Identifier: NCT01198925|
Recruitment Status : Unknown
Verified December 2014 by University Hospital, Ghent.
Recruitment status was: Recruiting
First Posted : September 10, 2010
Last Update Posted : December 5, 2014
Piperacillin-tazobactam is an acylureido-penicillin-beta-lactamase inhibitor combination and is frequently used in the empirical treatment of hospital-acquired infections because of its antipseudomonal activity. Similar to other beta-lactam antibiotics, piperacillin-tazobactam exhibits time-dependent killing and the T > MIC appears to be the best outcome predictor. Because a majority of infections are treated empirically, it is necessary to achieve a T > MIC equal to 50% of the dosing interval (50% T > MIC) against the most likely pathogens, including those with only moderate susceptibility The aim of this study is to compare the same dose of piperacillin/tazobactam administered by an extended infusion versus a continuous infusion. A pharmacokinetic study will be performed in patients treated by extended (loading dose 4 G/30 min followed by 4 X 4 G /3h) and continuous infusion (loading dose 4 G/30 min followed by 16G /24h).
A population pharmacokinetic analysis with Monte Carlo simulations will be used to determine 95% probability of target attainment (PTA95) versus MIC
|Condition or disease||Intervention/treatment||Phase|
|Infectious Disease||Drug: piperacillin continuous infusion Drug: piperacillin extended infusion||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessment of the Optimal Dosing of Piperacillin-tazobactam in Intensive Care Unit Patients: Extended Versus Continuous Infusion|
|Study Start Date :||September 2010|
|Estimated Primary Completion Date :||July 2015|
|Estimated Study Completion Date :||July 2015|
|Active Comparator: extended infusion||
Drug: piperacillin extended infusion
piperacillin extended infusion
|Experimental: continuous infusion||
Drug: piperacillin continuous infusion
piperacillin continuous infusion
- pharmacokinetics of piperacillin continuous infusion compared to piperacillin extended infusion [ Time Frame: 6 hours ]Determination of serum concentrations of piperacillin.
- 95% probability of target attainment (PTA95) versus MIC of different organisms. [ Time Frame: 96 hours ]Determination of the probability of target attainment versus MIC of different organisms.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01198925
|Contact: Johan Decruyenaere, MD, PhDfirstname.lastname@example.org|
|University Hospital Ghent||Recruiting|
|Principal Investigator: Johan Decruyenaere, MD, PhD|
|Principal Investigator:||Johan Decruyenaere, MD, PhD||University Hospital Ghent, Belgium|