Pseudomonas Aeruginosa Infection
Conditions
Keywords
Pseudomonas, Piperacillin, Beta-lactams, Continuous infusion, Intermittent infusion, Pharmacokinetics
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.
Interventions
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)
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with microbiological response | 3 days | \- Microbiological response: bacteriological eradication of causative organisms |
| Time to defervescence | 14 days | \- Time to the abatement of fever |
| 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 infection |
| Mortality | 28 days | — |
| Proportion of patients with adverse effects | 14 days & 60 days | — |
| Time to clinical cure | 14 days | — |
Countries
Spain