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

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ClinicalTrials.gov Identifier: NCT01198925
Recruitment Status : Unknown
Verified December 2014 by University Hospital, Ghent.
Recruitment status was:  Recruiting
First Posted : September 10, 2010
Last Update Posted : December 5, 2014
Sponsor:
Information provided by (Responsible Party):
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


Condition or disease Intervention/treatment Phase
Infectious Disease Drug: piperacillin continuous infusion Drug: piperacillin extended infusion Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of the Optimal Dosing of Piperacillin-tazobactam in Intensive Care Unit Patients: Extended Versus Continuous Infusion
Study Start Date : September 2010
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: extended infusion Drug: piperacillin extended infusion
piperacillin extended infusion
Experimental: continuous infusion Drug: piperacillin continuous infusion
piperacillin continuous infusion



Primary Outcome Measures :
  1. pharmacokinetics of piperacillin continuous infusion compared to piperacillin extended infusion [ Time Frame: 6 hours ]
    Determination of serum concentrations of piperacillin.


Secondary Outcome Measures :
  1. 95% probability of target attainment (PTA95) versus MIC of different organisms. [ Time Frame: 96 hours ]
    Determination of the probability of target attainment versus MIC of different organisms.



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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01198925


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

Locations
Belgium
University Hospital Ghent Recruiting
Ghent, Belgium
Principal Investigator: Johan Decruyenaere, MD, PhD         
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Johan Decruyenaere, MD, PhD University Hospital Ghent, Belgium

Additional Information:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01198925     History of Changes
Other Study ID Numbers: 2010/414
First Posted: September 10, 2010    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014

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

Additional relevant MeSH terms:
Communicable Diseases
Infection
Tazobactam
Piperacillin
Piperacillin, tazobactam drug combination
Penicillanic Acid
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action