NCT02981316已完成1 期
Treatment of Recurrent Clostridium Difficile Infection With RBX7455: A Dose-ranging, Prospective, Single Center, Open Label Phase I Trial
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Time to recurrence of Clostridium Difficile Infection (CDI)
研究概览
简要总结
The purpose of this study is to demonstrate the efficacy and safety of RBX7455 for the treatment of recurrent CDI in subjects who have had at least one recurrence after a primary episode (i.e., at least two episodes) and have completed at least two rounds of standard-of-care oral antibiotic therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Time to recurrence of Clostridium Difficile Infection (CDI)
时间窗: approximately 8 weeks
Number of patients experiencing adverse events
时间窗: approximately 6 months
次要结局
未报告次要终点
研究者
研究点 (2)
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