Pseudomonas Aeruginosa Infection Clinical Trial
Official title:
Efficacy and Safety of Piperacillin-Tazobactam Continuous Infusion vs Intermittent Infusion for Complicated or Nosocomial Pseudomonas Aeruginosa Infection or Suspected 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.
- 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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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