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

Study acronym: TrEAT_TD2
StatusRecruiting
PhasePhase 4
Started
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Record status
This record was last updated May 31, 2025 (before its estimated September 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Study sites: 3 to 4v6
  2. Primary completion date: Jun 2025 to Sep 2025
    • Study completion date: Sep 2025 to Dec 2025
    • Site details revised at 1 of 3 sites
    v5
  3. Primary completion date: Sep 2024 to Jun 2025
    • Study completion date: Dec 2024 to Sep 2025
    v4
  4. Re-verified, no change to tracked fieldsv3
  5. Primary completion date: Sep 2023 to Sep 2024v2 Show 4 more changesShow less
    • Study completion date: Dec 2023 to Dec 2024
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints revised (4)
    • Site details revised at 1 of 3 sites
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05677282
Lead Sponsor Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborators: Infectious Diseases Clinical Research Program, Uniformed Services University of the Health Sciences
Conditions
(from sponsor)		 Diarrhoea;Acute, Diarrhea Travelers
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov