Piperacillin-Tazobactam Continuous Versus Intermittent Infusion for Pseudomonas Aeruginosa
- Conditions
- Pseudomonas Aeruginosa Infection
- Interventions
- Registration Number
- NCT01577368
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Piperacillin continuous infusion Piperacillin-Tazobactam continuous infusion Piperacillin-Tazobactam 2gr (Loading dose DAY 1) plus Piperacillin-Tazobactam continuous infusion 8gr every 24 hours Piperacillin intermittent infusion Piperacillin-Tazobactam intermittent infusion Piperacillin-Tazobactam 4gr intermittent infusion 4gr every 8 hours
- Primary Outcome Measures
Name Time Method Proportion of patients with satisfactory clinical response (cure or improvement) at the end of Piperacillin-Tazobactam treatment 14 days * Clinical cure: complete resolution of all signs and symptoms of infection
* Clinical improvement: resolution or improvement of most signs and symptoms of infection
- Secondary Outcome Measures
Name Time Method Mortality 28 days Proportion of patients with clinical response (cure or improvement) at 3 days 3 days * Clinical cure: complete resolution of all signs and symptoms of infection
* Clinical improvement: resolution or improvement of most signs and symptoms of infectionProportion of patients with microbiological response 3 days - Microbiological response: bacteriological eradication of causative organisms
Proportion of patients with adverse effects 14 days & 60 days Time to defervescence 14 days - Time to the abatement of fever
Time to clinical cure 14 days
Trial Locations
- Locations (1)
Hospital Universitario Virgen del Rocío
🇪🇸Seville, Spain