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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by University Hospital, Ghent.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
University Hospital, Ghent Identifier:
First received: September 8, 2010
Last updated: December 4, 2014
Last verified: December 2014

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

Condition Intervention Phase
Infectious Disease
Drug: piperacillin continuous infusion
Drug: piperacillin extended infusion
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessment of the Optimal Dosing of Piperacillin-tazobactam in Intensive Care Unit Patients: Extended Versus Continuous Infusion

Resource links provided by NLM:

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • pharmacokinetics of piperacillin continuous infusion compared to piperacillin extended infusion [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    Determination of serum concentrations of piperacillin.

Secondary Outcome Measures:
  • 95% probability of target attainment (PTA95) versus MIC of different organisms. [ Time Frame: 96 hours ] [ Designated as safety issue: No ]
    Determination of the probability of target attainment versus MIC of different organisms.

Estimated Enrollment: 30
Study Start Date: September 2010
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: extended infusion Drug: piperacillin extended infusion
piperacillin extended infusion
Experimental: continuous infusion Drug: piperacillin continuous infusion
piperacillin continuous infusion


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01198925

University Hospital Ghent
Ghent, Belgium
Sponsors and Collaborators
University Hospital, Ghent
Principal Investigator: Johan Decruyenaere, MD, PhD University Hospital Ghent, Belgium
  More Information

Additional Information:
Responsible Party: University Hospital, Ghent Identifier: NCT01198925     History of Changes
Other Study ID Numbers: 2010/414 
Study First Received: September 8, 2010
Last Updated: December 4, 2014
Health Authority: Belgium: Ethics Committee
Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by University Hospital, Ghent:
Infectious disease
continuous infusion
extended infusion

Additional relevant MeSH terms:
Communicable Diseases
Piperacillin, tazobactam drug combination
Penicillanic Acid
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on January 18, 2017