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NCT02498301 · ClinicalTrials.gov registry record · NA
Trial Evaluating Chemoprophylaxis Against Travelers' Diarrhea - Prevent TD
A NA study, sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine.
- Completed
- Registry status
- NA
- Development phase
- 449
- Enrollment target
NCT02498301: Completed NA study, sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine.
NCT02498301 is a NA study that has completed, run by Henry M. Jackson Foundation for the Advancement of Military Medicine. The registered enrollment target is 449 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02498301, a NA study, has completed, sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 449 participants
- Enrollment target
Study Summary
The purpose of this study is to develop evidence on the relative efficacy of 2 rifaximin chemoprophylaxis regimens for the prevention of Travelers' Diarrhea (TD) in a deployed setting. An additional purpose is to explore the effect of chemoprophylaxis on microbial flora and antimicrobial resistance, and obtain parameter estimates to inform a cost-effectiveness model of chemoprophylaxis in prevention of TD. Information from this study will be used to develop management guidelines for the prevention of TD among deployed (United States (US) and United Kingdom (UK) military personnel. The study will be a multi-site, randomized, placebo-controlled, double-blind, clinical trial among deployed military personnel. The study will test 2 TD chemoprophylaxis regimens (once daily versus twice daily) of the same antibiotic, rifaximin, compared to a placebo. For the proposed chemoprophylaxis study described herein, cohorts of military personnel (US and UK) deploying/traveling overseas will be recruited prior to travel to participate and will undergo enrollment procedures as outlined in study appendices. Subjects who are eligible and agree to participate will be randomized to receive one of 3 regimens: (1) rifaximin 550 mg daily; (2) rifaximin 550 mg twice a day; or (3) placebo, to be taken while deployed. Chemoprophylaxis will be maintained for duration of travel or a predetermined period of up to 6 weeks and at least 2 weeks, which may include a period of up to 5 days of use after return to COO for deployments less than 6 weeks in duration. Clinical and laboratory data will be obtained before, during if available and after deployment/chemoprophylaxis.
Interventions
- DRUG Placebo
- DRUG Rifaximin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 449 participants |
| Start Date | 2015-11-10 |
| Est. Completion | 2019-12-31 |
| Phase | NA |
What the finished NCT02498301 record still lists
NCT02498301 is an interventional study that assigns participants to a tested intervention. The registered 449 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02498301 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02498301 about?
NCT02498301 is a clinical study titled "Trial Evaluating Chemoprophylaxis Against Travelers' Diarrhea - Prevent TD". The purpose of this study is to develop evidence on the relative efficacy of 2 rifaximin chemoprophylaxis regimens for the prevention of Travelers' Diarrhea (TD) in a deployed setting. An additional purpose is to explore the effect of chemoprophylaxis on microbial flora and antimicrobial resistance,...
What is the current status of trial NCT02498301?
This trial is currently completed. It is a NA study. The enrollment target is 449 participants. The study started on 2015-11-10. Estimated completion is 2019-12-31.
What interventions are being tested in trial NCT02498301?
The interventions under investigation include: Placebo (DRUG), Rifaximin (DRUG).
Who is sponsoring clinical trial NCT02498301?
This trial is sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine, which has 60 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02498301's enrollment target sits among peer trials
449 233rd of 2000 higher than 1,768 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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