Traveler's Diarrhea Clinical Trial
Official title:
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Rifamycin SV MMX for the Treatment of Traveler's Diarrhea
The purpose of this study is to determine whether Rifamycin SV MMX is a safe and effective treatment for Traveler's Diarrhea.
This is a multicenter, randomized, double-blind, placebo-controlled efficacy and safety study
conducted in patients traveling to developing regions with a known high incidence of TD.
Eligibility will be based on a symptom complex that is highly indicative of enteric acute
bacterial infection without indication of systemic infection.
Approximately 262 patients will be enrolled in the study and randomized at a 3:1 ratio to
receive Rifamycin SV MMX® 400 mg or placebo orally twice daily for 3 days (72 hours).
Treatment will be initiated on the day of Screening (Visit 1, Day 1), within 72 hours of
onset of diarrhea. Daily doses of study drug will be taken at breakfast time and dinner time
with a glass of liquid.
Safety and efficacy will be assessed.
Blood samples for routine safety tests (chemistry and hematology) will be collected at Visit
1 and at Visit 3 and sent to a local laboratory for analysis and reporting to the
Investigator for safety monitoring. Urine samples for routine urinalysis (dipstick only) will
be collected at Visits 1 and 3, and the results will be used by the Investigator for safety
monitoring.
If a patient's diarrhea and/or signs or symptoms of enteric infection worsen in a 24 hour
interval of time during the treatment period or if the enteric illness fails to improve after
24 hours or more of therapy, the patient may receive Rescue Therapy. Rescue Therapy will be
prescribed by the Investigator using local standard empiric therapy and/or guided by pathogen
identification.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
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