Travelers' Diarrhea
Conditions
Keywords
Diarrhea, travelers, Acute travelers' diarrhea
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.
Interventions
DRUGRifaximin
Rifaximin 200 mg TID for 3 days OR Rifaximin 600 mg Daily for 3 days
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from beginning therapy to passage of last unformed stool | 5 days |
Secondary
| Measure | Time frame |
|---|---|
| Side effects as reported by the subjects on diaries | 5 days |
Countries
Mexico
Outcome results
None listed