Single Daily Dose Rifaximin for the Treatment of Travelers' Diarrhea

• Status: Withdrawn
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Treatments: Rifamycins; Rifaximin

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