Title

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
  • Phase

    Phase 3
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Intervention/Treatment

    piperacillin tazobactam ...
  • Study Participants

    76
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.
Study Started
May 31
2011
Primary Completion
Jan 31
2014
Study Completion
Aug 31
2014
Last Update
Sep 22
2014
Estimate

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)

Piperacillin continuous infusion Experimental

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

Piperacillin intermittent infusion Active Comparator

Piperacillin-Tazobactam 4gr intermittent infusion 4gr every 8 hours

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
No Results Posted