Prevention of Travelers' Diarrhea in Subjects Traveling Outside the U.S.

Study Overview
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Brief Summary
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The primary objective of this study is to assess the safety and tolerability of rifaximin 600 mg (3 x 200-mg tablets) once daily compared with placebo when taken for 14 days by healthy subjects to prevent travelers' diarrhea (TD) from all causes.

Detailed Description
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Travelers' diarrhea (TD) is the most common illness in travelers to the developing world, occurring in 60% or more of international travelers to high-risk areas. It can be quite debilitating for the usual 2 to 4 days of the illness and may lead to disruption of travel plans. Findings from recent studies have indicated that the chronic post-travel illness may prove to be of greater clinical and public health significance than the acute illness. Specifically, persistent diarrhea has been reported in 2% to 10% of travelers developing diarrhea. Moreover, bacterial enterocolitis, including that associated with TD, leads to post-infectious irritable bowel syndrome in 4% to 31% of patients.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety of Rifaximin for the Prevention of Travelers' Diarrhea in Subjects Traveling Outside the United States

Conditions
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Diarrhea

Intervention / Treatment
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* Drug: Rifaximin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is in good health (as determined by medical history) Subject is planning on traveling anywhere outside the US (except Canada) for at least 5 and no more than 14 days Subject is scheduled to depart on their planned trip no later than 14 days and no earlier than 4 days after having blood drawn for clinical laboratory assessments and urine collected for a pregnancy test (females of childbearing potential only) Exclusion Criteria: Subject has hypersensitivity or allergy to rifaximin or rifampin Subject has known or suspected alcohol abuse or illicit drug use within 1 year of enrollment Subject participated in an investigational drug or device study within the 30 days prior to enrollment Subject received rifaximin in a previous clinical study Subject received any systemic or gastrointestinal-specific antibiotic within 7 days of the first dose of study drug Subject received antidiarrheal medication (eg, loperamide, lactobacillus, BSS, Kaopectate®) within 24 hours of the first dose of study drug

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rifaximin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint in this study is the assessment of safety and tolerability of rifaximin 600 mg QD compared to placebo. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A secondary endpoints of this study include assessment of the differences between the 2 treatment groups based upon the proportion of subjects with TD during the 14-day Treatment Period. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Travelers' Diarrhea, Xifaxan, Rifaximin, Escherichia coli, E coli, EAEC, Enteroaggregative E coli, ETEC, Enterotoxigenic E coli