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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-23

Study Completion Date

2018-05-03

Brief Summary

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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

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Detailed Description

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Conditions

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Infectious Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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extended infusion

Group Type ACTIVE_COMPARATOR

piperacillin extended infusion

Intervention Type DRUG

piperacillin extended infusion

continuous infusion

Group Type EXPERIMENTAL

piperacillin continuous infusion

Intervention Type DRUG

piperacillin continuous infusion

Interventions

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piperacillin continuous infusion

Intervention Type DRUG

piperacillin extended infusion

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No