Assessment of the Optimal Dosing of Piperacillin-tazobactam in Intensive Care Unit Patients: Extended Versus Continuous Infusion
Information source: University Hospital, Ghent
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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 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
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
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