NCT00875875撤回4 期
Single Daily Dose Rifaximin vs. Standard Thrice Daily Dosing for the 3-Day Treatment of Travelers' Diarrhea
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Time from beginning therapy to passage of last unformed stool
研究概览
简要总结
The study will compare durations of diarrhea among subjects who report to clinic for treatment and who receive either:
- standard rifaximin therapy at a dose of 200 mg three times a day for 3 days, OR
- a single 600 mg dose of rifaximin daily for 3 days.
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
- Single (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
- •passage of 3 or more unformed stools in 24 hours plus an additional symptom of enteric disease such as abdominal cramps, nausea, vomiting, or fever; and investigator verification that an unformed stool has been submitted.
- •is > 18 years of age
- •has diarrhea (at least three unformed stools in 24 hrs) plus at least one additional sign or symptom of enteric illness
- •has acute diarrhea less than 1 week's duration
- •willingness to provide a diarrhea stool sample
- •willingness to keep a daily diary for 5 days
- •signed informed consent
排除标准
- •fever or bloody diarrhea
- •has taken predictably effective antibiotics in the past week (e.g. quinolones, TMP/SMX, azalide or doxycycline)
- •is pregnant now, likely to become pregnant, or breast-feeding
- •has duration of diarrhea of greater than 1 weeks
- •is allergic to Rifampin or Rifaximin
- •has a history of significant underlying enteric, pulmonary, cardiac, renal disease, or any CNS disorder
- •is more than moderately dehydrated
研究组 & 干预措施
1
Active Comparator
This is the approved treatment regimen for travelers' diarrhea (600 mg)
干预措施: Rifaximin (Drug)
2
Active Comparator
This is the same dose as the standard dose, given once daily (200 mg)
干预措施: Rifaximin (Drug)
结局指标
主要结局
Time from beginning therapy to passage of last unformed stool
时间窗: 5 days
次要结局
- Side effects as reported by the subjects on diaries(5 days)
研究者
Charles D Ericsson
◦Professor and Dr. and Mrs. Carl V. Vartian Professor in Infectious Diseases
The University of Texas Health Science Center, Houston
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Rifaximin, Loperamide and the Combination to Treat Travelers' DiarrheaTravelers' DiarrheaNCT00292344The University of Texas Health Science Center, Houston316
已完成
1 期
Study Evaluating The Tolerability Of Multiple Doses Of HKI-272Healthy SubjectsNCT00757809Puma Biotechnology, Inc.50
已完成
2 期
Placebo Controlled Study of 3 Doses of Rifaximin-EIR Tablet to Treat Moderate, Active Crohn's DiseaseCrohn's DiseaseNCT00528073Alfasigma S.p.A.410
Unknown
4 期
Effects of Continuous Treatment With Rifaximin and Probiotics on the Gut Microbiota of Patients With IBS-DIBS - Irritable Bowel SyndromeGut MicrobiotaNCT04074421Second Affiliated Hospital, School of Medicine, Zhejiang University240
已完成
2 期
Study to Assess the Efficacy and Safety of Rifaximin Administered BID in the Treatment of Patients With Diarrhea-Associated Irritable Bowel SyndromeIrritable Bowel SyndromeNCT00269412Bausch Health Americas, Inc.525