Status:
COMPLETED
Rifaximin Versus Placebo in the Prevention of Travelers' Diarrhea
Lead Sponsor:
DuPont, Hurbert L., MD
Collaborating Sponsors:
Bausch Health Americas, Inc.
The University of Texas Health Science Center, Houston
Conditions:
Diarrhea
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the effectiveness of poorly absorbed rifaximin in the prevention of travelers' diarrhea among U.S. college students in Mexico for five weeks.
Detailed Description
This is an investigator-initiated proposal wherein 220 male and female subjects \>17 years of age from industrialized regions were randomized to receive a poorly absorbed antibiotic, rifaximin, in one...
Eligibility Criteria
Inclusion
- An Investigational Review Board approved, written informed consent is appropriately witnessed, signed and dated prior to any study-related activities
- Male or female subjects 18 years of age or older
- Able to read and understand English
- Enrolled and started on prophylaxis within 72 hours of arrival in Mexico
- If the subject is female, only women with non-childbearing potential or those who are not pregnant will be eligible. Urine pregnancy tests will be performed on those women who question their pregnancy status. Women on the study are required to employ a reliable method of contraception while taking medication. Forms of acceptable contraception include:
- Double barrier method of contraception.
- Oral birth control pills for at least two cycles before enrollment and continuing during therapy - subjects will be told they should use a barrier contraception method during the study as well.
- Norplant inserted at least one month before enrollment.
- An intrauterine device inserted by a qualified clinician.
- Medroxyprogesterone acetate for a minimum of one month before study and administered for one month following study completion.
- An approved birth control patch for at least two cycles before enrollment and continuing during therapy. OR
- Complete abstinence from intercourse for the two weeks of medication.
Exclusion
- Acute diarrhea (criteria for travelers' diarrhea above) within the past week
- Diarrhea developing within 24 hours of study enrollment
- In Mexico for more than 72 hours
- Receipt of one of the following classes of drugs: fluoroquinolone (any drug in class), macrolide or azalide or trimethoprim-sulfamethoxazole within the past week or during the three week study
- Receipt of other medication to decrease the occurrence of diarrhea (e.g. bismuth subsalicylate or lactobacillus preparations)
- For females, pregnancy or breast feeding during the three week study
- Receipt of antidiarrheal medication (loperamide, bismuth subsalicylate, kaopectate) within 24 hours of enrollment
- Hypersensitivity to rifaximin
- Unstable medical condition including chronic renal failure and insulin dependent diabetes.
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
End Date :
September 1 2003
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00098384
Start Date
June 1 2003
End Date
September 1 2003
Last Update
May 9 2006
Active Locations (1)
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1
Universidad Autonoma de Guadalajara
Guadalajara, Jalisco, Mexico