A Randomised Placebo Controlled Trial of "Follow on" Rifaximin for the Prevention of Relapse of Clostridium Associated Diarrhoea
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 1
- 主要终点
- Difference in % relapse between Rifaximin and placebo at 12 weeks
研究概览
简要总结
Clostridium difficile associated diarrhoea is an important cause of morbidity in patients treated with antibiotics, especially in hospital. Clinical relapse occurs after up to 30% of initially successful treatments for colitis. Preliminary reports suggest that Rifaximin, a poorly absorbed antibiotic used to treat travellers diarrhoea can prevent relapse. We plan to carry out a randomised placebo controlled trial to test the hypothesis that Rifaximin given in a reducing dose over 4 weeks after successful treatment will reduce the relapse rate.
详细描述
Aims i) To examine efficacy of a follow-on course of Rifaximin given after a successful initial course of standard treatment, in the prevention of relapse in C. difficile associated diarrhoea (CDAD).
ii) To examine changes in faecal microbiota in patients given Rifaximin vs. Placebo.
Treatment 4 weeks treatment with Rifaximin or Placebo tablets. Tapering dose starting with 2 x 200mg tablets three times a day (total = 1.2g per day) for the 1st 2 weeks, reduced to 1 x 200mg tablet three times a day (total = 0.6g per day) for the 2nd 2 weeks.
Primary endpoint: The difference in % relapse between Rifaximin and placebo at 12 weeks
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
研究组 & 干预措施
Placebo
Identical looking tablet
干预措施: Placebo (Drug)
Rifaximin , Xifaxanta™
2 weeks of Rifaximin 400mg thrice daily then 2 weeks of Rifaximin 200mg thrice daily Modified Xifaxanta™ (rifaximin film-coated tablet) manufactured by Alfa Wasermann (AW),
干预措施: Rifaximin (Drug)
结局指标
主要结局
Difference in % relapse between Rifaximin and placebo at 12 weeks
时间窗: 12 weeks
The difference in % relapse between Rifaximin and placebo at 12 weeks
次要结局
- Proportion relapsed, re-hospitalisation and bowel symptoms(12 weeks - 6 months)