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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 ┬Ál - 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?

Infectious Disease

Study Interventions

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

Study Arms

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.

extended infusion

continuous infusion

Study Status

Unknown status

Start Date: September 2010

Completed Date: July 2015

Phase: Phase 4

Type: Interventional

Design:

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

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01198925

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