Rifaximin for Prevention of Travellers' Diarrhea
- Registration Number
- NCT00742469
- Lead Sponsor
- Bausch Health Americas, Inc.
- Brief Summary
The purpose of this study is to determine if 600 mg of rifaximin, taken once a day for 14 days by healthy subjects, is safe and effective for the prevention of travellers' diarrhea compared to placebo.
- Detailed Description
To determine if 600 mg of rifaximin, taken once a day for 14 days by healthy subjects, is safe and effective for the prevention of travellers' diarrhea compared to placebo.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 210
Inclusion Criteria
- travelling to Mexico within 72 hours of enrollment
- read and understand English
- in good health
Exclusion Criteria
- acute diarrhea within previous 7 days
- taken FQs (any drug in this class), macrolide, azalide, or trimethoprim-sulfamethoxazole within 7 days or enrollment or anytime during study.
- taken antidiarrheal medication within 24 hours of enrollment or anytime during study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Rifaximin Rifaximin 2 Placebo Placebo
- Primary Outcome Measures
Name Time Method Cumulative Occurrence of Travellers' Diarrhea (TD) for Rifaximin 600 mg QD Compared to Placebo Over 14 Days of Treatment 14 days The efficacy of 14 days of rifaximin 600 mg once daily (QD) compared with placebo when taken by healthy subjects to prevent travelers' diarrhea (TD) resulting from all causes.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of San Diego
🇲🇽Guadalajara, Jalisco, Mexico