Piperacillin-Tazobactam Continuous Versus Intermittent Infusion for Pseudomonas Aeruginosa

Condition(s) targeted: Pseudomonas Aeruginosa Infection

Intervention: Piperacillin-Tazobactam continuous infusion (Drug); Piperacillin-Tazobactam intermittent infusion (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

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.

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

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

Primary outcome: Proportion of patients with satisfactory clinical response (cure or improvement) at the end of Piperacillin-Tazobactam treatment

Secondary outcome:

Proportion of patients with clinical response (cure or improvement) at 3 days

Proportion of patients with microbiological response

Time to defervescence

Time to clinical cure

Mortality

Proportion of patients with adverse effects

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Hospital Universitario Virgen del Rocío, Seville 41013, Spain

Starting date: May 2011
Last updated: September 19, 2014