Piperacillin-Tazobactam Continuous Versus Intermittent Infusion for Pseudomonas Aeruginosa

Summary

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.

Conditions

• Pseudomonas Aeruginosa Infection

Interventions

DRUG

Piperacillin-Tazobactam continuous infusion

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

DRUG

Piperacillin-Tazobactam intermittent infusion

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

Sponsors & Collaborators

• Ministerio de Sanidad y Política social

  collaborator UNKNOWN

• Hospitales Universitarios Virgen del Rocío

  collaborator OTHER

• Hospital Universitario Virgen Macarena

  collaborator OTHER

• Hospital Son Espases

  collaborator OTHER

• Hospital Son Llatzer

  collaborator OTHER

• Complejo Hospitalario de Especialidades Juan Ramón Jimenez

  collaborator OTHER

• University Hospital Virgen de las Nieves

  collaborator OTHER

• Hospital General de Cataluña

  collaborator UNKNOWN

• Hospital Infanta Sofia

  collaborator OTHER

• Hospital Universitario Ntra. Sra. de La Candelaria

  collaborator UNKNOWN

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-05-31

Primary Completion

2014-01-31

Completion

2014-08-31

Countries

• Spain

Study Locations