A Pre-emptive Prevention Bundle for Patients at High Risk for Hospital-onset Clostridioides Difficile
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Risk of C. difficile infection among patients colonized with C. difficile comparing the intervention to the control group
研究概览
简要总结
Clostridioides difficile (C. difficile) is the most common healthcare-associated pathogen, causing >500,000 infections and >29,000 deaths per year in the US. Traditional approaches to reduce hospital-onset CDI focus on identifying, isolating, and treating symptomatic patients to prevent transmission to other patients. Recent genomic epidemiology studies, however, suggest that most hospital-onset CDI cases are attributable to asymptomatic carriers who either progress from colonization to active infection themselves or transmit C. difficile to other patients while asymptomatic. This trial will evaluate an intervention to pre-emptively identify asymptomatic C. difficile carriers and then implement a patient-tailored prevention package to protect the carrier from progression to active infection and to prevent transmission from the carrier to other patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Patients admitted to ICU or Oncology units and identified to carry C. Difficile via VRE swab
排除标准
- •Patients not identified as carriers of C. difficile and patients not admitted to ICU or oncology units
研究组 & 干预措施
Patients colonized with toxigenic C. difficile who do not receive the prevention bundle
Patients colonized with toxigenic C. difficile, identified by testing routinely collected swabs for vancomycin-resistant enterococcus screening, who receive standard of care
干预措施: Arm 1: Routine care (Other)
Patients colonized with toxigenic C. difficile who receive the prevention bundle
Patients colonized with toxigenic C. difficile, identified by testing routinely collected swabs for vancomycin-resistant enterococcus screening, who receive a preemptive prevention bundle for C. difficile including enhanced room cleaning, C. difficile precautions, pharmacist review and optimization of antibiotics and antacids, and consideration of vancomycin prophylaxis.
干预措施: Arm 2: Preemptive C. difficile infection prevention bundle (Other)
结局指标
主要结局
Risk of C. difficile infection among patients colonized with C. difficile comparing the intervention to the control group
时间窗: 24 months
Incidence rate ratio of CDI in colonized patients who received the intervention bundle versus who did not receive the intervention bundle
次要结局
未报告次要终点
研究者
Meghan A. Baker, M.D
Associate Hospital Epidemiologist
Brigham and Women's Hospital
