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Rifaximin 600: Single Daily Dose Rifaximin for the Treatment of Travelers' Diarrhea

Sponsor
The University of Texas Health Science Center, Houston (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00875875
Collaborator
(none)
0
Enrollment
1
Location
2
Arms

Study Details

Study Description

Brief Summary

The study will compare durations of diarrhea among subjects who report to clinic for treatment and who receive either:

  1. standard rifaximin therapy at a dose of 200 mg three times a day for 3 days, OR

  2. a single 600 mg dose of rifaximin daily for 3 days.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Single Daily Dose Rifaximin vs. Standard Thrice Daily Dosing for the 3-Day Treatment of Travelers' Diarrhea
Study Start Date :
Jun 1, 2009
Actual Primary Completion Date :
Jun 1, 2009
Anticipated Study Completion Date :
Jun 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

This is the approved treatment regimen for travelers' diarrhea (600 mg)

Drug: Rifaximin
Rifaximin 200 mg TID for 3 days OR Rifaximin 600 mg Daily for 3 days
Other Names:
  • Xifaxin

    		•
    Active Comparator: 2

    This is the same dose as the standard dose, given once daily (200 mg)

    Drug: Rifaximin
    Rifaximin 200 mg TID for 3 days OR Rifaximin 600 mg Daily for 3 days
    Other Names:
  • Xifaxin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time from beginning therapy to passage of last unformed stool [5 days]

    Secondary Outcome Measures

    1. Side effects as reported by the subjects on diaries [5 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    Exclusion Criteria:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Enteric Disease Clinic Guadalajara Jalisco Mexico

    Sponsors and Collaborators

    • The University of Texas Health Science Center, Houston

    Investigators

    • Principal Investigator: Charles D Ericsson, MD, University of Texas Medical School at Houston

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Charles D Ericsson, ◦Professor and Dr. and Mrs. Carl V. Vartian Professor in Infectious Diseases, The University of Texas Health Science Center, Houston
    ClinicalTrials.gov Identifier:
    NCT00875875
    Other Study ID Numbers:
    • Ericsson-001
    First Posted:
    Apr 6, 2009
    Last Update Posted:
    Jun 10, 2015
    Last Verified:
    Jun 1, 2015
    Keywords provided by Charles D Ericsson, ◦Professor and Dr. and Mrs. Carl V. Vartian Professor in Infectious Diseases, The University of Texas Health Science Center, Houston
    Diarrhea, travelers
    Acute travelers' diarrhea
    Additional relevant MeSH terms:
    Dysentery
    Diarrhea
    Rifaximin

    Study Results

    No Results Posted as of Jun 10, 2015