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
Lead SponsorFundación Pública Andaluza
StatusCompleted No Results Posted
Indication/ConditionPseudomonas Aeruginosa Infection
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.
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.
Piperacillin-Tazobactam 2gr (Loading dose DAY 1) plus Piperacillin-Tazobactam continuous infusion 8gr every 24 hours (DAY 1-14)
Piperacillin-Tazobactam intermittent infusion 4gr every 8 hours (DAY 1-14)
Piperacillin-Tazobactam 2gr (Loading dose DAY 1) plus Piperacillin-Tazobactam continuous infusion 8gr every 24 hours
Piperacillin-Tazobactam 4gr intermittent infusion 4gr every 8 hours
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