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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University Hospital, Ghent
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01198925
First received: September 8, 2010
Last updated: February 1, 2013
Last verified: February 2013

September 8, 2010
February 1, 2013
September 2010
July 2013   (final data collection date for primary outcome measure)
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.
To evaluate pharmacokinetics of piperacillin continuous infusion compared to piperacillin extended infusion [ Time Frame: 96 hours ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01198925 on ClinicalTrials.gov Archive Site
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.
Determine 95% probability of target attainment (PTA95) versus MIC of different organisms. [ Time Frame: 96 hours ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Assessment of the Optimal Dosing of Piperacillin-tazobactam in Intensive Care Unit Patients: Extended Versus Continuous Infusion
Assessment of the Optimal Dosing of Piperacillin-tazobactam in Intensive Care Unit Patients: Extended Versus Continuous Infusion

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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Infectious Disease
  • Drug: piperacillin continuous infusion
    piperacillin continuous infusion
  • Drug: piperacillin extended infusion
    piperacillin extended infusion
  • Active Comparator: extended infusion
    Intervention: Drug: piperacillin extended infusion
  • Experimental: continuous infusion
    Intervention: Drug: piperacillin continuous infusion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
July 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Johan Decruyenaere, MD, PhD johan.decruyenaere@ugent.be
Belgium
 
NCT01198925
2010/414
No
University Hospital, Ghent
University Hospital, Ghent
Not Provided
Principal Investigator: Johan Decruyenaere, MD, PhD University Hospital Ghent, Belgium
University Hospital, Ghent
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP