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RECRUITING
NCT05677282
PHASE4

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Rifaximin 550 MG

Rifaximin 550 mg as a single dose administered orally.

DRUG

Azithromycin 500 MG

Azithromycin 500 mg as a single dose administered orally.

DRUG

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