Rifaximin Versus Placebo in the Prevention of Travelers' Diarrhea

May 8, 2006 updated by: DuPont, Hurbert L., MD

A Randomized, Double-Blind, Single Center, Comparative Dose Ranging Study of Rifaximin Vs. Placebo in the Prevention of Travelers' Diarrhea Due to Enteropathogenic Bacteria

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 of three doses at mealtime (when they are exposed to diarrhea-causing bacteria), 200 mg once a day, 200 mg twice a day or 200 mg three times a day versus a placebo starting on arrival (within the first 72 hours) to Mexico and continuing for two weeks with diaries of symptoms recorded for three weeks. Adverse events in the subjects were followed for five weeks. If mild diarrhea (1 or 2 unformed stools/24 hours plus an enteric symptom) or diarrheal illness (>2 unformed stools/24 hours plus an enteric symptom) developed, subjects provided a stool sample to determine cause of illness. Forty subjects provided stool samples after 7 days and 14 days treatment to see if their intestinal bacterial flora had developed resistance to rifaximin and to see the level of drug achieved. Stool samples from these forty subjects were studied for enteric pathogens to look for asymptomatic infection during the period of prophylaxis. The stool samples collected were initially processed in our enteric laboratories in Guadalajara, Mexico. Specialized tests such as studies of toxigenicity for enterotoxigenic E. coli and enteroadherence for enteroaggregative E. coli were done in Houston.

Study Type

Interventional

Enrollment

220

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico
        • Universidad Autonoma de Guadalajara

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Occurrence of diarrhea, defined as passage of >2 unformed stools/24 hr plus one or more signs or symptoms of enteric infection

Secondary Outcome Measures

Outcome Measure
Occurrence of mild diarrhea (1 or 2 unformed stools/24 hr plus a sign or symptom)
Treatment failure (not well in five days)
Occurrence of moderate to severe abdominal pain/cramps or intestinal gas related symptoms

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DuPont, Hurbert L., MD

Collaborators

The University of Texas Health Science Center, Houston
Bausch Health Americas, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Study Completion

September 1, 2003

Study Registration Dates

First Submitted

December 7, 2004

First Submitted That Met QC Criteria

December 7, 2004

First Posted (Estimate)

December 8, 2004

Study Record Updates

Last Update Posted (Estimate)

May 9, 2006

Last Update Submitted That Met QC Criteria

May 8, 2006

Last Verified

December 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR 03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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