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

Primary Purpose

Infectious Disease

Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
piperacillin continuous infusion
piperacillin extended infusion
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infectious Disease focused on measuring Infectious disease, piperacillin, continuous infusion, extended infusion

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Ghent

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

extended infusion

continuous infusion

Arm Description

Outcomes

Primary Outcome Measures

pharmacokinetics of piperacillin continuous infusion compared to piperacillin extended infusion
Determination of serum concentrations of piperacillin.

Secondary Outcome Measures

95% probability of target attainment (PTA95) versus MIC of different organisms.
Determination of the probability of target attainment versus MIC of different organisms.

Full Information

First Posted
September 8, 2010
Last Updated
May 4, 2018
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT01198925
Brief Title
Assessment of the Optimal Dosing of Piperacillin-tazobactam in Intensive Care Unit Patients: Extended Versus Continuous Infusion
Official Title
Assessment of the Optimal Dosing of Piperacillin-tazobactam in Intensive Care Unit Patients: Extended Versus Continuous Infusion
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
September 23, 2010 (Actual)
Primary Completion Date
November 16, 2012 (Actual)
Study Completion Date
May 3, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infectious Disease
Keywords
Infectious disease, piperacillin, continuous infusion, extended infusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
extended infusion
Arm Type
Active Comparator
Arm Title
continuous infusion
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
piperacillin continuous infusion
Intervention Description
piperacillin continuous infusion
Intervention Type
Drug
Intervention Name(s)
piperacillin extended infusion
Intervention Description
piperacillin extended infusion
Primary Outcome Measure Information:
Title
pharmacokinetics of piperacillin continuous infusion compared to piperacillin extended infusion
Description
Determination of serum concentrations of piperacillin.
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
95% probability of target attainment (PTA95) versus MIC of different organisms.
Description
Determination of the probability of target attainment versus MIC of different organisms.
Time Frame
96 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johan Decruyenaere, MD, PhD
Organizational Affiliation
University Hospital Ghent, Belgium
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
Country
Belgium

12. IPD Sharing Statement

Links:
URL
http://www.uzgent.be
Description
website University Hospital Ghent, Belgium

Learn more about this trial

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

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