NCT01208922已完成3 期
A Randomised, Double-blind, Double-dummy, Multi-centre, Comparative Parallel-group Study to Evaluate the Efficacy and Safety of Oral Daily Rifamycin SV-MMX® 400 mg b.i.d. vs. Ciprofloxacin 500 mg b.i.d. in the Treatment of Acute Infectious Diarrhoea in Travellers
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 835
- 试验地点
- 19
- 主要终点
- Time to Last Unformed Stool (TLUS)
研究概览
简要总结
The purpose of this study is to prove the non-inferiority of Rifamycin SV-MMX® versus Ciprofloxacin for the treatment of adults with traveller's diarrhoea.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent,
- •Men or women between 18 and 85 years of age,
- •History of arriving from their country of residence in the industrialized part of the world within the past 4 weeks,
- •Presenting with acute infectious diarrhoea (defined as at least 3 unformed, watery or soft stools accompanied by symptoms within 24 hours preceding randomisation with duration of illness ≤ 72 hours),
- •Presence of one or more signs or symptoms of enteric infection (moderate to severe gas/flatulence, nausea, vomiting, abdominal cramps or pain, rectal tenesmus, fecal urgency),
- •Women of childbearing potential had to apply during the entire duration of the study a highly effective method of birth control
排除标准
- •Residency in any country with high incidence rate of TD within the past 6 months,
- •Fever (defined as a body (oral) temperature >100.4°F or 38.0°C; antipyretic medication should not have been administered in the 6 hours prior to this assessment),
- •Known or suspected infection with non-bacterial pathogen,
- •Presence of diarrhoea of >72 hours duration,
- •Presence of grossly bloody stool,
- •Presence of moderate or severe dehydration (i.e. symptoms of hypovolemia such as orthostatic hypotension, dizziness or wrinkling of skin),
- •History of inflammatory bowel disease or celiac disease,
研究组 & 干预措施
Group A
Experimental
Rifamycin SV-MMX® 200 mg tablets
干预措施: Rifamycin SV-MMX® (Drug)
Group B
Active Comparator
Ciprofloxacin 500 mg capsules
干预措施: Ciprofloxacin (Drug)
结局指标
主要结局
Time to Last Unformed Stool (TLUS)
时间窗: 5 days
Time to Last Unformed Stool (TLUS), defined as the interval in hours between the first dose of study drug and the last unformed stool passed, after which clinical cure was declared.
次要结局
- Number of Patients With Clinical Cure(5 days)
研究者
研究点 (19)
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