Single Dose Antibiotic Treatment of Acute Watery Diarrhea, Rifaximin Versus Azithromycin, With Loperamide Adjunct

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-28

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diarrhoea;Acute Diarrhea Travelers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, double-blind, active-controlled, treatment trial of Travelers Diarrhea (TD) in an outpatient setting enrolling deployed United States (US) service members assigned to Joint Task Force (JTF)-Bravo, Soto Cano Air Base, Honduras and Camp Lemonnier, Djibouti (CLDJ) and United Kingdom (UK) military personnel to British Army Training Unit, Kenya (BATUK) who present for medical care with acute TD.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Rifaximin with loperamide

Group Type EXPERIMENTAL

Rifaximin 550 MG

Intervention Type DRUG

Rifaximin 550 mg as a single dose administered orally.

Loperamide

Intervention Type DRUG

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).

Azithromycin mg with loperamide

Group Type ACTIVE_COMPARATOR

Azithromycin 500 MG

Intervention Type DRUG

Azithromycin 500 mg as a single dose administered orally.

Loperamide

Intervention Type DRUG

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).

Interventions

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Rifaximin 550 MG

Rifaximin 550 mg as a single dose administered orally.

Intervention Type DRUG

Azithromycin 500 MG

Azithromycin 500 mg as a single dose administered orally.

Intervention Type 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).

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No