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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
Rifaximin 550 mg as a single dose administered orally.
Azithromycin 500 mg as a single dose administered orally.
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).
Camp Lemonnier Djibouti
Djibouti, Djibouti
RECRUITINGJTF-Bravo, Soto Cano AB
Comayagua, Honduras
RECRUITINGBritish Army Training Site UK
Nanyuki, Kenya
RECRUITINGFort Magsaysay & Camp Aguinaldo
Santa Rosa, Nueva Ecija, Philippines
ACTIVE_NOT_RECRUITINGTherapeutic efficacy of single-dose rifaximin (550 mg) with loperamide in treating acute watery diarrhea compared to single-dose azithromycin (500 mg) with loperamide.
Time to last unformed stool (TLUS), in hours, is calculated from the time of antibiotic dose to last unformed (diarrheal) stool (TLUS).
Time frame: Up to 1 week (up to 168 hours)
Proportion of participants no longer meeting TD illness criteria at 24 hours
The clinical efficacy cure rate at 24h is the proportion of participants at the 24h follow up after the initial treatment who met the end point of not meeting TD illness.
Time frame: 24 hours
Proportion of participants no longer meeting TD illness criteria at 72 hours
For the clinical efficacy cure rate at 72h is the proportions of participants who met the end point 1. no report of unformed/diarrheal/loose/liquid stool (LLS) that meet TD illness \>24h after initial treatment and 2. TD-associated symptoms present at 24h were not reported as moderate or greater
Time frame: 72 hours
Proportion of participants with recurrence of TD illness after previous resolution of TD illness
TD recurrence at 7d follow up if participants meet TD illness and had the previous cure resolution at 24h or 72h
Time frame: 7 days
Proportions of serious adverse events (SAE) at 21 days
Proportions of serious adverse events (SAE)
Time frame: 21 days
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