Assessment of the Optimal Dosing of Piperacillin-tazobactam in Intensive Care Unit Patients: Extended Versus Continuous Infusion

Phase 4

Completed

• Conditions: Infectious Disease
• Interventions: Drug: piperacillin extended infusion; Drug: piperacillin continuous infusion

• Registration Number: NCT01198925
• Lead Sponsor: University Hospital, Ghent

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-08
• Study First Submitted QC: 2010-09-08
• Study First Posted: 2010-09-10
• Study Start: 2010-09-23
• Primary Completion: 2012-11-16
• Status Verified: 2018-05
• Study Completion: 2018-05-03
• Last Update Submitted: 2018-05-04
• Last Update Posted: 2018-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
extended infusion	piperacillin extended infusion	-
continuous infusion	piperacillin continuous infusion	-

Primary Outcome Measures

Name	Time	Method
pharmacokinetics of piperacillin continuous infusion compared to piperacillin extended infusion	6 hours	Determination of serum concentrations of piperacillin.

Secondary Outcome Measures

Name	Time	Method
95% probability of target attainment (PTA95) versus MIC of different organisms.	96 hours	Determination of the probability of target attainment versus MIC of different organisms.

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, Belgium