NCT00979056已完成3 期
Prospective, Randomised, Placebo Controlled, Double Blind Monocenter Trial for the Prophylactic Treatment of Diarrhoea With Rifaximin for Travellers to South- and Southeast-Asia
Dr. Philipp Zanger, MD MSc DTM1 个研究点 分布在 1 个国家目标入组 258 人开始时间: 2009年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 258
- 试验地点
- 1
- 主要终点
- Efficacy of the prevention of travellers diarrhea with rifaximin by measurement of frequency and consistence of the stool. Diarrhea will be defined as passage of >2 unformed stools/24 hr plus one or more signs or symptoms of enteric infection.
研究概览
简要总结
The aim of the study is to investigate the efficacy of the prophylactic treatment with rifaximin to prevent travellers diarrhoea.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults ≥ 18 and < 65 years
- •Good general condition (according to history and clinical examination)
- •Written informed consent
- •No pregnancy
- •No breast feeding
- •Efficacious contraception (e.g. oral, double-barrier) during the study and 4 weeks after termination of the study
- •No participation in other clinical trials 4 weeks before, during participation, and 4 weeks after participation in this study
- •Planned travel period between 6 and 28 days
- •Planned travel to South- and Southeast Asia
- •Planned time to arrival in South- or Southeast Asia ≤ 24 hours
排除标准
- •Pregnancy
- •Breast feeding
- •Age < 18 and ≥ 65 years
- •No written informed consent
- •Chronic gastrointestinal disease and/ or immune insufficiency
- •Low general condition (according to history and clinical examination)
- •Regular medication with gastrointestinal side-effects and/or immunosuppressive medication
- •Participation in other clinical trials 4 weeks before, during and 4 weeks after termination of the study
- •No efficacious contraception
- •Planned travel period < 6 and > 28 days
- •Planned travel outside South- and Southeast Asia
- •Vaccination against cholera using DUKORAL within 12 months prior to inclusion
- •Planned time to arrival in South- or Southeast Asia > 24 hours
- •Known hypersensitivity against rifaximin or rifamycin-derivatives in general
- •Known lactose intolerance
研究组 & 干预措施
Rifaximin
Experimental
干预措施: Rifaximin (Drug)
Lactose
Placebo Comparator
干预措施: Lactose (Drug)
结局指标
主要结局
Efficacy of the prevention of travellers diarrhea with rifaximin by measurement of frequency and consistence of the stool. Diarrhea will be defined as passage of >2 unformed stools/24 hr plus one or more signs or symptoms of enteric infection.
时间窗: From the first day of the travel (travel period between 6 and 28 days) to 1 week after the subject's return to Germany
次要结局
- Documentation of adverse effects and tolerance of prophylaxis with rifaximin.(From the first day of the travel (travel period between 6 and 28 days) to 1 week after the subject's return to Germany)
- Evaluation of prevention of post infectious irritable bowel syndrome.(From the first day of the travel (travel period between 6 and 28 days) to 6 months after the subject's return to Germany)
研究者
Dr. Philipp Zanger, MD MSc DTM
Oberarzt
University Hospital Tuebingen
研究点 (1)
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