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

Sponsor:

Information provided by (Responsible Party):

University Hospital, Ghent

ClinicalTrials.gov Identifier:

NCT01198925

First received: September 8, 2010

Last updated: December 4, 2014

Last verified: December 2014

History of Changes

Purpose

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 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

Resource links provided by NLM:

Drug Information available for: Piperacillin sodium Piperacillin Tazobactam

U.S. FDA Resources

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 ]
Determination of serum concentrations of piperacillin.

Secondary Outcome Measures:

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.


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

Eligibility


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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

Additional Information:

website University Hospital Ghent, Belgium This link exits the ClinicalTrials.gov site


Responsible Party:	University Hospital, Ghent
ClinicalTrials.gov Identifier:	NCT01198925 History of Changes
Other Study ID Numbers:	2010/414
Study First Received:	September 8, 2010
Last Updated:	December 4, 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

ClinicalTrials.gov processed this record on August 18, 2017

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