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 December 2014 by University Hospital, Ghent
Sponsor:
University Hospital, Ghent
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
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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 Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: 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:
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 ] [ Designated as safety issue: No ]Determination of serum concentrations of piperacillin.
Secondary Outcome Measures:
- 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.
| 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) |
| Genders Eligible for Study: | Both |
| 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
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:
| 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 |
| Health Authority: | Belgium: Ethics Committee Belgium: Federal Agency for Medicinal Products and Health Products |
Keywords provided by University Hospital, Ghent:
|
Infectious disease piperacillin continuous infusion extended infusion |
Additional relevant MeSH terms:
|
Communicable Diseases Infection Piperacillin, tazobactam drug combination Penicillanic Acid Piperacillin Tazobactam |
Anti-Bacterial Agents Anti-Infective Agents Beta-Lactamase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 26, 2016