Efficacy of Oral Vancomycin Prophylaxis for Prevention of Recurrent Clostridium Difficile Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 2
- 主要终点
- Recurrent Clostridium Difficile Infection (CDI)
研究概览
简要总结
This study evaluates the efficacy of prophylaxis with oral vancomycin for preventing recurrent Clostridium difficile Infection (CDI) in patients who have experienced at least one CDI episode in the last 180 days and are receiving antibiotics for a non CDI condition. Participants will be randomized to receive either placebo or oral vancomycin in addition to their prescribed antibiotic therapy.
详细描述
Many patients who have a CDI experience recurrent or relapsing symptoms. The investigators are studying whether vancomycin in low doses will help prevent further CDI episodes and how this therapy impacts patients' gastrointestinal microbiome and composition.
Patients with a history of past CDI who are receiving antibiotics for a non-CDI condition will be invited to participate. Approximately half of the participants will receive a low-dose capsule of vancomycin and half will receive a placebo. Participants will continue taking the vancomycin/placebo for 5 days after their prescribed antibiotics end.
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
- Double (Participant, 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
- •Willing to provide informed consent.
- •Willing to comply with all study procedures and be available for the duration of the study.
- •Documented diagnosis of at least one CDI within the last 180 days with treatment completed.
- •Currently receiving systemic antibiotics for a non-CDI condition with anticipated duration of no more than 2 weeks.
- •Females of childbearing potential must have a negative pregnancy test prior to randomization and agree to use adequate contraception prior to randomization, for the duration of the study, and for 4 weeks following study completion.
- •Have received no more than 72 hours of non-CDI antibiotics.
排除标准
- •History of hypersensitivity or allergy to oral vancomycin.
- •Current use of oral vancomycin
- •Patients on concurrent treatment with metronidazole or tetracycline monotherapy for any indication
- •Patients diagnosed with inflammatory bowel disorder (Crohn's disease), or bacterial gastrointestinal infection cause by agents other than C. difficile (e.g. Salmonella sp.), toxic megacolon and/or known small bowel ileus.
- •Dysphagia (inability to swallow capsules) or unwilling to swallow capsules.
- •Major gastrointestinal surgery within 3 months of enrollment (does not include appendectomy or cholecystectomy).
- •Any history of total colectomy or bariatric surgery.
- •Unable or unwilling to fulfill study requirements.
- •Expected life expectancy < 6 months.
- •Patients enrolled in another clinical trial with investigational drugs within 30 days prior to randomization.
- •Women who are pregnant or breast-feeding.
- •Any patient deemed not suitable for study participation at the discretion of the study investigator.
- •Diarrhea (3 or more loose stools in a 24 hour period) at enrollment.
研究组 & 干预措施
Vancomycin
125 mg, oral capsule by mouth, once daily, for the duration of standard-of-care antibiotic therapy plus 5 days
干预措施: Vancomycin (Drug)
Placebo
125 mg placebo capsule by mouth, once daily, for the duration of standard-of-care antibiotic therapy plus 5 days
干预措施: Placebo (Drug)
结局指标
主要结局
Recurrent Clostridium Difficile Infection (CDI)
时间窗: 8 weeks
Determine whether CDI recurrence is decreased in patients taking oral vancomycin as prophylactic therapy in addition to standard-of-care antibiotics that patients are taking for non-CDI reasons.
次要结局
- Gut Microbiome Composition(8 weeks)
- Vancomycin-resistant Enterococcus (VRE) Colonization in Stool Samples of Patients Receiving Vancomycin vs. Patients Receiving Placebo(8 weeks)
- Determine Whether Clostridium Difficile Positivity on Any Stool Sample is a Predictor of CDI Recurrence.(8 weeks)