Comparing rifaximin and azithromycin for treating traveler's diarrhea
A Randomized Controlled Trial Evaluating Single-dose Rifaximin Versus Azithromycin With Loperamide Adjunct for Treatment of Acute Watery Diarrhea
This study is testing whether a single dose of rifaximin works better than azithromycin for treating traveler's diarrhea when combined with loperamide.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Henry M. Jackson Foundation for the Advancement of Military Medicine Academic / other |
| Locations | 4 sites (Djibouti and 3 other locations) |
| Trial ID | NCT05677282 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of a single dose of rifaximin with loperamide against the standard treatment of azithromycin with loperamide for acute watery traveler's diarrhea. Participants will be randomly assigned to receive either treatment and will provide blood and stool samples to assess infection and immune responses. They will also maintain a daily symptom diary and undergo follow-up evaluations by study doctors. The goal is to determine which antibiotic provides better outcomes for patients suffering from this condition.
Who should consider this trial
Good fit: Ideal candidates are active duty military personnel aged 18-60 experiencing acute watery diarrhea.
Not a fit: Patients with allergies to rifamycins, macrolides, or loperamide, or those who have received antibiotic therapy in the past 72 hours may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients suffering from acute watery diarrhea.
How similar studies have performed: Other studies have shown varying success with antibiotic treatments for traveler's diarrhea, but this specific comparison of rifaximin and azithromycin is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Active duty military, 18-60 years old 2. Presence of acute watery diarrhea (3 or more loose/liquid stools in 24 hours or 2 loose/liquid stools in 24 hours and associated symptoms such as nausea, vomiting, abdominal cramps or tenesmus) lasting \<96 hours in duration that impacts function in activities and/or performance of primary duties. Refer to recruitment decision tree below. 3. Eligible for ambulatory management. (Note: Ambulatory management in this study means that the patient can be treated on an outpatient basis to include up to 23 hours of medical observation and IV therapies.) 4. Able to comply with follow-up procedures. 5. Will remain in country for at least 7 days or an assurance that follow-up can be arranged elsewhere. Exclusion Criteria: 1. Allergy to rifamycins, macrolides, or loperamide (not including mild gastrointestinal upset). 2. Antibiotic therapy in the 72 hours prior to presentation (excluding malaria prophylaxis with mefloquine, malarone, chloroquine/proguanil, tafenoquine, or doxycycline). 3. Concomitant medications with known drug-drug interactions with any of the study drugs (includes theophylline, digoxin, warfarin, chloroquine and hydroxychloroquine). 4. Current or history of liver disease or other serious health conditions based on review by study physician. 5. Acute dysentery and/or febrile illness (temperature \> 100.4°F \[38.1°C\]). 6. Presence of symptoms \>96 hours prior to initiating treatment. 7. Use of \>4 mg loperamide or use of any amount of loperamide for greater than 24 hours prior to enrollment. Prior use of bismuth subsalicylate or other anti-diarrheal, non-antibiotic therapy in the 48 hours prior to enrollment. 8. Positive pregnancy test at presentation (unknown effects with rifaximin). All female participants will be administered a urine pregnancy test prior to enrollment. 9. Previously screened or randomized in this study.
Where this trial is running
Djibouti and 3 other locations
- Camp Lemonnier Djibouti — Djibouti, Djibouti (Recruiting)
- JTF-Bravo, Soto Cano AB — Comayagua, Honduras (Recruiting)
- British Army Training Site UK — Nanyuki, Kenya (Recruiting)
- Fort Magsaysay & Camp Aguinaldo — Santa Rosa, Nueva Ecija, Philippines (Active_not_recruiting)
Study contacts
- Study coordinator: Principal Investigator
- Email: dtribble@idcrp.org
- Phone: 240-855-6584
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.