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Single Dose Antibiotic Treatment of Acute Watery Diarrhea, Rifaximin Versus Azithromycin, With Loperamide Adjunct
Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
Summary
The purpose of this study is to compare a single dose of rifaximin with loperamide to the current standard approach of single dose azithromycin with loperamide for the treatment of acute watery traveler's diarrhea (TD). The study requires 1) taking a single dose antibiotic plus loperamide to treat TD, 2) providing blood and stool samples at different time points to evaluate infection and immune responses, 3) completing a daily symptom diary following treatment, 4) being seen by the study doctor to monitor illness and recovery, and 5) completing a brief electronic questionnaire at 3 months. Participants will be randomly assigned to one of the two treatment groups. The two groups are 1) rifaximin 550 mg as a single dose with loperamide 4 mg initially followed by 2 mg after each unformed stool or 2) azithromycin 500 mg as a single dose with loperamide 4 mg initially followed by 2 mg after each unformed stool. Both groups will take the antibiotic dose and 4 mg of loperamide.
Official title: A Randomized Controlled Trial Evaluating Single-dose Rifaximin Versus Azithromycin With Loperamide Adjunct for Treatment of Acute Watery Diarrhea
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2022-10-28
Completion Date
2025-12
Last Updated
2025-05-31
Healthy Volunteers
No
Conditions
Interventions
Rifaximin 550 MG
Rifaximin 550 mg as a single dose administered orally.
Azithromycin 500 MG
Azithromycin 500 mg as a single dose administered orally.
Loperamide
4 mg loperamide administered orally with study antibiotic (rifaximin or azithromycin). Additional loperamide to use as needed, but not to exceed 16 mg/day for 2 days as per licensed use (one 2 mg capsule after each looses stool).
Locations (4)
Camp Lemonnier Djibouti
Djibouti, Djibouti
JTF-Bravo, Soto Cano AB
Comayagua, Honduras
British Army Training Site UK
Nanyuki, Kenya
Fort Magsaysay & Camp Aguinaldo
Santa Rosa, Nueva Ecija, Philippines