NCT03671967招募中4 期
Piperacillin Tazobactam Versus Meropenem for Treatment of Bloodstream Infections Caused by Cephalosporin-resistant Enterobacteriaceae- a Non-inferiority Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 1,084
- 试验地点
- 14
- 主要终点
- All-cause mortality
研究概览
简要总结
Data regarding optimal treatment for extended-spectrum beta-lactamase (ESBL) producing Enterobacteriaceae blood-stream infection are lacking. Observational studies show conflicting results when comparing treatment with combination beta-lactam-beta-lactamase inhibitor and carbapenems. The investigators aim to evaluate the effect of definitive treatment with meropenem vs. piperacillin-tazobactam on the outcome of patients with bacteremia due to cephalosporin-non-susceptible Enterobacteriaceae. The investigators hypothesize that piperacillin-tazobactam is non-inferior to meropenem.
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
- None
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
- •Adults (age ≥ 18 years)
- •New onset BSI due to E. coli or Klebsiella spp. in one or more blood cultures associated with evidence of infection.
- •The microorganism will have to be non-susceptible to third generation cephalosporins (ceftriaxone and ceftazidime) and susceptible to both PTZ and meropenem (see microbiological methods).
- •Both community and hospital-acquired bacteremias will be included.
- •We will permit the inclusion of bacteremias due to E. coli or Klebsiella spp. with concomitant growth in blood of skin commensals considered as contaminants.
排除标准
- •More than 72 hr. elapsed since initial blood culture taken, regardless of the time covering antibiotics were started (up to 72 hrs.).
- •Polymicrobial bacteremia. Polymicrobial bacteremia will be defined as either growth of two or more different species of microorganisms in the same blood culture, or growth of different species in two or more separate blood cultures within the same episode.
- •Patients with prior bacteremia or infection that have not completed antimicrobial therapy for the previous infectious episode.
- •Patients with septic shock at the time of enrollment and randomization, defined as at least 2 measurements of systolic blood pressure < 90 mmHg and/or use of vasopressors (dopamine>15μg/kg/min, adrenalin>0.1μg/kg/min, noradrenalin>0.1μg/kg/min, vasopressin any dose) in the 12 hours prior to randomization. In the absence of the use of vasopressors, a systolic blood pressure <90 would need to represent a deviation for the patient's known normal blood pressure.
- •BSI due to specific infections known at the time of randomization:
- •Endocarditis / endovascular infections
- •Osteomyelitis (not resected)
- •Central nervous system infections
- •Allergy to any of the study drugs confirmed by history taken by the investigator
- •Previous enrollment in this trial
- •Concurrent participation in another interventional clinical trial
- •Imminent death (researcher's assessment of expected death within 48 hrs. of recruitment)
研究组 & 干预措施
piperacillin tazobactam
Experimental
干预措施: Piperacillin/tazobactam (Drug)
meropenem
Active Comparator
干预措施: Meropenem (Drug)
结局指标
主要结局
All-cause mortality
时间窗: 30 days from randomization
Treatment failure
时间窗: 7 days from randomization
death OR fever \> 38°C in the last 48 hours OR lack of resolution of symptoms attributed to the focus of infection OR Sequential Failure Organ Assessment (SOFA) score increasing OR positive blood cultures by the time point assessed
次要结局
- All-cause mortality(14 and 90 days from randomization)
- Clinically or microbiologically documented infection other than Gram-negative bacteremia(90 days from randomization)
- Treatment failure(14 days and 30 days from randomization)
- Microbiological failure(7 days and 14 days from randomization)
- Recurrent positive blood cultures (relapse)(30 days and 90 days from randomization)
- Clostridium difficile associated diarrhea(90 days from randomization)
- Total antibiotic days(30 days and 90 days from randomization)
- Adverse events(30 days from randomization)
- Number of hospital re-admissions(90 days from randomization)
- Development of resistance(90 days from randomization)
- Carriage of carbapenemase-producing Enterobacteriaceae (CPE) and non-CPE carbapenem-resistant Enterobacteriaceae in-hospital(90 days from randomization)
- Total in-hospital days(30 days and 90 days from randomization)
研究者
研究点 (14)
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