跳至主要内容
临床试验/NCT05389904
NCT05389904招募中不适用

A Pre-emptive Prevention Bundle for Patients at High Risk for Hospital-onset Clostridioides Difficile

Brigham and Women's Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年7月25日最近更新:
适应症
干预措施

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

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

Active Comparator

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

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Meghan A. Baker, M.D

Associate Hospital Epidemiologist

Brigham and Women's Hospital

研究点 (1)

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