Piperacillin-Tazobactam Continuous Versus Intermittent Infusion for Pseudomonas Aeruginosa — PiperTazo  

Pseudomonas Aeruginosa Infection Clinical Trial

Official title: Efficacy and Safety of Piperacillin-Tazobactam Continuous Infusion vs Intermittent Infusion for Complicated or Nosocomial Pseudomonas Aeruginosa Infection or Suspected Infection

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pseudomonas Aeruginosa Infection
• Pseudomonas Infections

• NCT number: NCT01577368
• Study type: Interventional
• Source: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Status: Completed
• Phase: Phase 3
• Start date: May 2011
• Completion date: August 2014