Piperacillin-Tazobactam Continuous Versus Intermittent Infusion for Pseudomonas Aeruginosa

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Collaborators: Complejo Hospitalario de Especialidades Juan Ramón Jimenez; Hospital General de Cataluña; Hospital Infanta Sofia; Hospital Son Espases; Hospital Son Llatzer; Hospital Universitario Ntra. Sra. de La Candelaria; Hospital Universitario Virgen Macarena; Hospitales Universitarios Virgen del Rocío; Ministerio de Sanidad y Política social; University Hospital Virgen de las Nieves
• Treatments: Penicillanic Acid; Piperacillin; Piperacillin, Tazobactam Drug Combination; Tazobactam

Criteria

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