Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02498301
The ClinicalTrials.gov registry entry for NCT02498301 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 449 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Henry M. Jackson Foundation for the Advancement of Military Medicine, which has 60 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02498301 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.