Back to resultsSingle Daily Dose Rifaximin for the Treatment of Travelers' Diarrhea (Rifaximin 600)
Primary Purpose
Travelers' Diarrhea
Status
Withdrawn
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
Rifaximin
Sponsored by
About this trial
This is an interventional treatment trial for Travelers' Diarrhea focused on measuring Diarrhea, travelers, Acute travelers' diarrhea
Eligibility Criteria
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
Sites / Locations
- Enteric Disease Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
This is the approved treatment regimen for travelers' diarrhea (600 mg)
This is the same dose as the standard dose, given once daily (200 mg)
Outcomes
Primary Outcome Measures
Time from beginning therapy to passage of last unformed stool
Secondary Outcome Measures
Side effects as reported by the subjects on diaries
Full Information
NCT ID
NCT00875875
First Posted
April 3, 2009
Last Updated
June 8, 2015
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT00875875
Brief Title
Single Daily Dose Rifaximin for the Treatment of Travelers' Diarrhea
Acronym
Rifaximin 600
Official Title
Single Daily Dose Rifaximin vs. Standard Thrice Daily Dosing for the 3-Day Treatment of Travelers' Diarrhea
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Withdrawn
Why Stopped
No study population in Mexico (H1N1). Study withdrawn from IRB consideration.
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study will compare durations of diarrhea among subjects who report to clinic for treatment and who receive either:
standard rifaximin therapy at a dose of 200 mg three times a day for 3 days, OR
a single 600 mg dose of rifaximin daily for 3 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Travelers' Diarrhea
Keywords
Diarrhea, travelers, Acute travelers' diarrhea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
This is the approved treatment regimen for travelers' diarrhea (600 mg)
Arm Title
2
Arm Type
Active Comparator
Arm Description
This is the same dose as the standard dose, given once daily (200 mg)
Intervention Type
Drug
Intervention Name(s)
Rifaximin
Other Intervention Name(s)
Xifaxin
Intervention Description
Rifaximin 200 mg TID for 3 days OR Rifaximin 600 mg Daily for 3 days
Primary Outcome Measure Information:
Title
Time from beginning therapy to passage of last unformed stool
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Side effects as reported by the subjects on diaries
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles D Ericsson, MD
Organizational Affiliation
University of Texas Medical School at Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Enteric Disease Clinic
City
Guadalajara
State/Province
Jalisco
Country
Mexico
12. IPD Sharing Statement
Learn more about this trial
Single Daily Dose Rifaximin for the Treatment of Travelers' Diarrhea
We'll reach out to this number within 24 hrs