Efficacy and Safety of Piperacillin-Tazobactam Continuous Infusion vs Intermittent Infusion for Complicated or Nosocomial Pseudomonas Aeruginosa Infection or Suspected Infection
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Proportion of patients with satisfactory clinical response (cure or improvement) at the end of Piperacillin-Tazobactam treatment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Creatinine clearance < 20 ml/min
- •Dialysis or hemoperfusion
研究组 & 干预措施
Piperacillin continuous infusion
Piperacillin-Tazobactam 2gr (Loading dose DAY 1) plus Piperacillin-Tazobactam continuous infusion 8gr every 24 hours
干预措施: Piperacillin-Tazobactam continuous infusion (Drug)
Piperacillin intermittent infusion
Piperacillin-Tazobactam 4gr intermittent infusion 4gr every 8 hours
干预措施: Piperacillin-Tazobactam intermittent infusion (Drug)
结局指标
主要结局
Proportion of patients with satisfactory clinical response (cure or improvement) at the end of Piperacillin-Tazobactam treatment
时间窗: 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
次要结局
- Time to clinical cure(14 days)
- Proportion of patients with adverse effects(14 days & 60 days)
- Mortality(28 days)
- Proportion of patients with clinical response (cure or improvement) at 3 days(3 days)
- Proportion of patients with microbiological response(3 days)
- Time to defervescence(14 days)