Actively Recruiting
Single Dose Antibiotic Treatment of Acute Watery Diarrhea, Rifaximin Versus Azithromycin, With Loperamide Adjunct
Led by Henry M. Jackson Foundation for the Advancement of Military Medicine · Updated on 2025-05-31
150
Participants Needed
4
Research Sites
161 weeks
Total Duration
On this page
Sponsors
H
Henry M. Jackson Foundation for the Advancement of Military Medicine
Lead Sponsor
I
Infectious Diseases Clinical Research Program
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Single Dose Antibiotic Treatment of Acute Watery Diarrhea, Rifaximin Versus Azithromycin, With Loperamide Adjunct
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Active duty military between 18 and 60 years old
- Acute watery diarrhea lasting less than 96 hours with 3 or more loose stools in 24 hours or 2 loose stools plus symptoms like nausea, vomiting, cramps, or tenesmus
- Diarrhea impacts daily activities or military duties
- Eligible for outpatient treatment including up to 23 hours of observation and intravenous therapy
- Able to comply with follow-up procedures
- Will remain in the country for at least 7 days or have arranged follow-up elsewhere
You will not qualify if you...
- Allergy to rifamycins, macrolides, or loperamide (except mild stomach upset)
- Antibiotic use within 72 hours before study entry, except certain malaria prevention drugs
- Taking medications that interact with study drugs (such as theophylline, digoxin, warfarin, chloroquine, hydroxychloroquine)
- Current or past liver disease or serious health conditions as reviewed by study doctor
- Acute dysentery or fever above 100.4°F (38.1°C)
- Symptoms lasting more than 96 hours before treatment
- Use of more than 4 mg loperamide or any loperamide use over 24 hours before enrollment
- Use of bismuth subsalicylate or other non-antibiotic anti-diarrheal drugs within 48 hours before enrollment
- Positive pregnancy test at enrollment; all female participants will be tested
- Previously enrolled or randomized in this study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Camp Lemonnier Djibouti
Djibouti, Djibouti
Actively Recruiting
2
JTF-Bravo, Soto Cano AB
Comayagua, Honduras
Actively Recruiting
3
British Army Training Site UK
Nanyuki, Kenya
Actively Recruiting
4
Fort Magsaysay & Camp Aguinaldo
Santa Rosa, Nueva Ecija, Philippines
Active, Not Recruiting
Research Team
P
Principal Investigator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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