Single Dose Antibiotic Treatment of Acute Watery Diarrhea, Rifaximin Versus Azithromycin, With Loperamide Adjunct
Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
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