Screening to Prophylax Against Clostridium Difficile Infection
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,294
- 试验地点
- 1
- 主要终点
- The Incidence of CDI in Inpatients Receiving Vancomycin Prophylaxis vs. Placebo Who Are on High-risk Antibiotics and Are Colonized With Toxigenic C. Difficile.
研究概览
简要总结
The goal of this study is to evaluate whether using vancomycin orally can prevent CDI in patients who are colonized with C. difficile who are admitted to the hospital and need antibiotics for another infection.
详细描述
Screening to Prophylax against CDI (SToP CDI) is a prospective, single-center, double-blinded, randomized, placebo-controlled study of the effectiveness of vancomycin vs. placebo for preventing CDI in patients colonized with toxigenic C. difficile and receiving high-risk antibiotics. The investigators plan to screen 2500 patients to randomize 200.
Consented patients will have a stool sample collected and tested for presence of toxigenic C. difficile by polymerase chain reaction (PCR) test. Patients who test negative will simply be followed for development, severity and outcome of CDI. Patients who test positive (are colonized with C. difficile) will be randomized to one of two arms:
Arm 1: Patients receive 125 mg vancomycin by mouth (PO) every 6 hours as prophylaxis against C. difficile for the duration of their antibiotic treatment +3 days.
Arm 2: Patients receive placebo by mouth (PO) every 6 hours for the duration of their antibiotic treatment +3 days.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Expected duration of admission sufficient to complete screening and enrollment
- •Able to give informed consent
- •Initiated on one of the following antibiotics within the prior 72 hours with an expected duration of at least 72 hours from enrollment: clindamycin, ampicillin, ampicillin/sulbactam, amoxicillin, amoxicillin/clavulanate, moxifloxacin, levofloxacin, piperacillin/tazobactam, or any cephalosporin
- •Maximum expected duration of antibiotics 8 weeks
- •Able to take oral study medications
- •Able to provide a stool sample during hospitalization or within 3 days of discharge
- •Reasonably expected to be able to complete follow up
排除标准
- •Chron's disease, ulcerative colitis, celiac disease, or other chronic diarrheal illness
- •CDI within prior 90 days
- •Currently on metronidazole, oral vancomycin, rifaximin, fidaxomicin, or any other antibiotic active against C. difficile
- •Current diarrhea
- •Current ileostomy, colostomy or other form of surgically disconnected gut such that oral therapy would not be expected to reach the entire lumen of the gut
- •Pregnancy or breast feeding (determined prior to randomization)
- •Travel to an area of endemic diarrheal illness within the last 30 days
- •Life expectancy of less than 60 days
- •Known allergy to vancomycin
- •Participation with other research trials that could impact the results of this trial within the last 30 days
- •Previously enrolled in this study
研究组 & 干预措施
Placebo
Placebo every 6 hours. A placebo will look like the drug being studied, but have no active ingredients, in this case it will be fruit punch with vitamins added to mimic the taste of vancomycin.
干预措施: Placebo (Other)
vancomycin
Vancomycin 125 mg by mouth every 6 hours
干预措施: Vancomycin (Drug)
结局指标
主要结局
The Incidence of CDI in Inpatients Receiving Vancomycin Prophylaxis vs. Placebo Who Are on High-risk Antibiotics and Are Colonized With Toxigenic C. Difficile.
时间窗: 12 weeks after treatment
Number of participants with CDI in this subgroup of patients as assessed by clinical presentation, polymerase chain reaction (PCR) testing of stool, and EIA test for production of toxins. Patients are considered to have CDI if they have a positive PCR test, a positive toxin enzyme immunoassay (EIA) test, and clinical symptoms compatible with CDI. This outcome is only applicable to the two randomized arms.
次要结局
- The Severity of CDI in Patients Receiving Vancomycin Prophylaxis vs. Placebo.(12 weeks after treatment)
- The Outcome of CDI in Patients Receiving Vancomycin Prophylaxis vs. Placebo.(12 weeks after treatment)
- The Prevalence of Toxigenic C. Difficile Colonization Among the Inpatient Population Treated With High-risk Antibiotics Based on C. Difficile PCR.(12 weeks after treatment)
- The Incidence of CDI in Patients Initiated on High Risk Antibiotics Who Are Not Colonized With Toxigenic C. Difficile.(12 weeks after antibiotics)
研究者
Matthew Sims, MD, PhD
Director Infectious Disease Research, Beaumont Health; Professor of Internal Medicine and Foundational Medical Studies, OUWB School of Medicine
William Beaumont Hospitals