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

Last updated: December 5, 2024
Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
Overall Status: Active - Recruiting

Phase

4

Condition

Lactose Intolerance

Stomach Discomfort

Colic

Treatment

Loperamide

Azithromycin 500 MG

Rifaximin 550 MG

Clinical Study ID

NCT05677282
IDCRP-115
  • Ages 18-60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 2loose/liquid stools in 24 hours and associated symptoms such as nausea, vomiting,abdominal cramps or tenesmus) lasting <96 hours in duration that impacts function inactivities and/or performance of primary duties. Refer to recruitment decision treebelow.

  3. Eligible for ambulatory management. (Note: Ambulatory management in this study meansthat the patient can be treated on an outpatient basis to include up to 23 hours ofmedical 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 bearranged elsewhere.

Exclusion

Exclusion Criteria:

  1. Allergy to rifamycins, macrolides, or loperamide (not including mildgastrointestinal upset).

  2. Antibiotic therapy in the 72 hours prior to presentation (excluding malariaprophylaxis with mefloquine, malarone, chloroquine/proguanil, tafenoquine, ordoxycycline).

  3. Concomitant medications with known drug-drug interactions with any of the studydrugs (includes theophylline, digoxin, warfarin, chloroquine andhydroxychloroquine).

  4. Current or history of liver disease or other serious health conditions based onreview 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 hoursprior 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 femaleparticipants will be administered a urine pregnancy test prior to enrollment.

  9. Previously screened or randomized in this study.

Study Design

Total Participants: 150
Treatment Group(s): 3
Primary Treatment: Loperamide
Phase: 4
Study Start date:
October 28, 2022
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Camp Lemonnier Djibouti

    Djibouti,
    Djibouti

    Active - Recruiting

  • JTF-Bravo, Soto Cano AB

    Comayagua,
    Honduras

    Active - Recruiting

  • British Army Training Site UK

    Nanyuki,
    Kenya

    Site Not Available

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