NCT01577368

Piperacillin-Tazobactam Continuous Versus Intermittent Infusion for Pseudomonas Aeruginosa

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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)

Timeline

• Start date: 2011-05-01
• Primary completion: 2014-01-01
• Completion: 2014-08-01
• First posted: 2012-04-13
• Last updated: 2014-09-22

Locations

1 site across 1 country: Spain