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

Information source: University Hospital, Ghent
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infectious Disease

Intervention: piperacillin continuous infusion (Drug); piperacillin extended infusion (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University Hospital, Ghent

Official(s) and/or principal investigator(s):
Johan Decruyenaere, MD, PhD, Principal Investigator, Affiliation: University Hospital Ghent, Belgium

Overall contact:
Johan Decruyenaere, MD, PhD, Email: johan.decruyenaere@ugent.be

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Johan Decruyenaere, MD, PhD, Email: johan.decruyenaere@ugent.be

University Hospital Ghent, Ghent, Belgium; Recruiting
Johan Decruyenaere, MD, PhD, Principal Investigator
Additional Information

website University Hospital Ghent, Belgium

Starting date: September 2010
Last updated: December 4, 2014

Page last updated: August 23, 2015

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