Assessment of the Optimal Dosing of Piperacillin-tazobactam in Intensive Care Unit Patients: Extended Versus Continuous Infusion
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|ClinicalTrials.gov Identifier: NCT01198925|
Recruitment Status : Completed
First Posted : September 10, 2010
Last Update Posted : May 11, 2018
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)|
|Actual Enrollment :||14 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|
|Actual Study Start Date :||September 23, 2010|
|Actual Primary Completion Date :||November 16, 2012|
|Actual Study Completion Date :||May 3, 2018|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01198925
|University Hospital Ghent|
|Principal Investigator:||Johan Decruyenaere, MD, PhD||University Hospital Ghent, Belgium|