Piperacillin-Tazobactam Continuous Versus Intermittent Infusion for Pseudomonas Aeruginosa

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

PHASE3

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2014-08-31

Brief Summary

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The main objective is to verify that the administration of piperacillin / tazobactam administered by continuous infusion to treat complicated infections or with known or suspected nosocomial isolation of Pseudomonas aeruginosa is superior in efficacy to a 30% higher dose administered in conventional short infusion.

The secondary objectives were compared between the following variables:

* Microbiological response at 3 days of starting treatment
* Time to microbiological cure
* Clinical response at 3 days of starting treatment
* Time to achieve defervescence
* To examine the relationship between pharmacokinetic variables and parameters of efficacy and safety
* To test the hypothesis that continuous infusion maintains adequate plasma drug levels compared with levels achieved with intermittent administration.
* Cost-effectiveness analysis
* Occurrence of adverse effects

To this end, we designed a multicenter, randomized, controlled, double blind, comparing both forms of administration in patients with complicated or nosocomial infection with or without isolation of Pseudomonas aeruginosa.

Patients who are candidates for inclusion are classified according to APACHE II and to have or not isolation of Pseudomonas aeruginosa. Subsequently be randomized to receive piperacillin-tazobactam by continuous infusion or short. Primary endpoint was measured as the ultimate effectiveness of treatment and other variables such as high efficiency, safety, pharmacokinetic and pharmacoeconomic.

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Detailed Description

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Conditions

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Pseudomonas Aeruginosa Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Piperacillin continuous infusion

Piperacillin-Tazobactam 2gr (Loading dose DAY 1) plus Piperacillin-Tazobactam continuous infusion 8gr every 24 hours

Group Type EXPERIMENTAL

Piperacillin-Tazobactam continuous infusion

Intervention Type DRUG

Piperacillin-Tazobactam 2gr (Loading dose DAY 1) plus Piperacillin-Tazobactam continuous infusion 8gr every 24 hours (DAY 1-14)

Piperacillin intermittent infusion

Piperacillin-Tazobactam 4gr intermittent infusion 4gr every 8 hours

Group Type ACTIVE_COMPARATOR

Piperacillin-Tazobactam intermittent infusion

Intervention Type DRUG

Piperacillin-Tazobactam intermittent infusion 4gr every 8 hours (DAY 1-14)

Interventions

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Piperacillin-Tazobactam continuous infusion

Piperacillin-Tazobactam 2gr (Loading dose DAY 1) plus Piperacillin-Tazobactam continuous infusion 8gr every 24 hours (DAY 1-14)

Intervention Type DRUG

Piperacillin-Tazobactam intermittent infusion

Piperacillin-Tazobactam intermittent infusion 4gr every 8 hours (DAY 1-14)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Complicated or Nosocomial Pseudomonas Aeruginosa Infection or Suspected Infection
* \> 18 years and \> 40 kg
* Negative pregnancy test for women within fertile period
* Informed consent signature

Exclusion Criteria

* Life expectancy \< 72 hr
* Central Nervous System (CNS) infection
* Ventilator-associated pneumonia
* Severe Neutropenia (\<500 cells/ml)
* Acinetobacter baumannii or extended spectrum beta lactamase (ESBL) suspected infection
* Cystic fibrosis
* Shock
* Creatinine clearance \< 20 ml/min
* Dialysis or hemoperfusion

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No