Single Dose Antibiotic Treatment of Acute Watery Diarrhea, Rifaximin Versus Azithromycin, With Loperamide Adjunct

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.

NCT Number	NCT05677282
Lead Sponsor	Henry M. Jackson Foundation for the Advancement of Military Medicine Collaborators: Infectious Diseases Clinical Research Program, Uniformed Services University of the Health Sciences
Conditions	Diarrhoea;Acute, Diarrhea Travelers
Enrollment	150 participants
Start Date	2022-10-28
Primary Completion	2025-09 (estimated)
Study Completion	2025-12 (estimated)
Updated on ClinicalTrials.gov	2025-05-31