Skip to main content
OpenTrials
Completed

NCT Number: NCT01198925

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Infectious Disease Communicable Diseases Disease Attributes Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Ghent

Ghent, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

piperacillin continuous infusion

Drug

piperacillin continuous infusion

piperacillin extended infusion

Drug

piperacillin extended infusion

Primary outcomes

  1. pharmacokinetics of piperacillin continuous infusion compared to piperacillin extended infusion

    Time frame: 6 hours

    Determination of serum concentrations of piperacillin.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2018
First posted
Sep 10, 2010
Registry last updated
May 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.