Infectious Disease | Assessment of the Optimal Dosing of Piperacillin-tazobactam in Intensive Care Unit Patients: Extended Versus Continuous Infusion
Infectious Disease research study
What is the primary objective of this study?
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
Who is eligible to participate?
Inclusion Criteria: - Adult patients (> 18 years) admitted on the intensive care unit (surgical and medical surgery). - Starting a treatment with piperacillin/tazobactam - Signed informed consent - Hematocrit >= 21% - Available arterial line Exclusion Criteria: - age <18 or >75 years - patient's weight <50 or >100 kg - renal insufficiency (estimated clearance < 50 ML /MIN) - haemodialysis - WBC < 1000 103 µl - estimated survival <5 days - meningitis or other proven infections of the CNS - IgE-mediated allergy to penicillins - pregnancy - patients having participated in another study <30 days before inclusion in the present study - retrospectively, marked deterioration of the renal function during the study period - retrospectively, treatment < 96 h
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:piperacillin continuous infusionpiperacillin continuous infusion
Drug:piperacillin extended infusionpiperacillin extended infusion
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: September 2010
Completed Date: July 2015
Phase: Phase 4
Primary Outcome: pharmacokinetics of piperacillin continuous infusion compared to piperacillin extended infusion
Secondary Outcome: 95% probability of target attainment (PTA95) versus MIC of different organisms.
Study sponsors, principal investigator, and references
Principal Investigator: Johan Decruyenaere, MD, PhD
Lead Sponsor: University Hospital, Ghent