Clinical Trial: Trial Evaluating Chemoprophylaxis Against Travelers' Diarrhea - Prevent TD

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomized, Placebo-Controlled, Double-Blind, Clinical Trial Evaluating Two Dose Regimens of Rifaximin (550 mg Daily or 550 mg Twice Daily) for Chemoprophylaxis Against Travelers' Diarrhea (TD) Amon

Brief 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.


Detailed Summary:

The primary efficacy outcome will be assessed by review of the symptom memory aid (TravMil diary). Subjects will follow a symptom memory aid from the onset of a disease episode and record relevant symptomatology (date/time and number of diarrheal episodes, associated symptoms such as fever, vomiting, nausea, bloody stools and cramps, severity of symptoms, functional activity). Use of antibiotics and/or Imodium (loperamide) for each episode will also be recorded). An additional memory aid to capture occurrence of solicited adverse events, use of new prescription medications, as well as adherence to study medication regimen will be utilized by subjects during deployment and returned (or re-created with study personnel if lost or incomplete) at follow-up Memory aid data will be actively sought from all subjects via required in-person follow-up.

Secondary efficacy outcomes will also largely be derived from the self-report of subjects via use of the memory aid data. Secondary safety evaluation will be performed at the end of study visit based on history obtained from the subject regarding medical treatment requiring events while deployed.

Individuals will be enrolled prior to travel/deployment. At the time of enrollment they will undergo eligibility criteria review, informed consent process, baseline assessment (demographics, medical history, others), sample collection (blood and stool), and blinded randomization into a study arm.

Episodes of diarrhea are expected to occur while on study drug. Subjects will be instructed and expected to seek care for these episodes from medical assets available to them at COD.

Subjects will be instructed to discontinue study drug if they develop diarrhea and are given antibiotic therapy. It is no
Sponsor: Uniformed Services University of the Health Sciences

Current Primary Outcome: Efficacy - Risk of travelers diarrhea during chemoprophylaxis as measured by self-report via use of a memory aid [ Time Frame: 24hr ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Efficacy as determined by use of a symptom memory aid. [ Time Frame: For a duration of prophylaxis which will be on average 3-4 weeks or a maximum of 6 weeks ]
    Proportion of subjects in each treatment group with TD, with mild diarrhea, with TD associated with isolation of a pathogen and pathogen type, total diarrhea days, work days and performance loss due to diarrhea, comparison of incidence of TD
  • Solicited adverse events as collected from the subject and using a memory aid [ Time Frame: For the duration of prophylaxis which will be on average 3-4 weeks or a maximum of 6 weeks. ]
    Solicited adverse events will be collected by use of a memory aid which will be reviewed at the last clinic visit, on average within 4 months from study enrollment.


Original Secondary Outcome: Same as current

Information By: Uniformed Services University of the Health Sciences

Dates:
Date Received: July 6, 2015
Date Started: April 2016
Date Completion: November 2017
Last Updated: June 6, 2016
Last Verified: June 2016