Trial Evaluating Chemoprophylaxis Against Travelers' Diarrhea - Prevent TD
Status:
Active, not recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
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.
Phase:
N/A
Details
Lead Sponsor:
Uniformed Services University of the Health Sciences
Collaborators:
Ministry of Defence, United Kingdom Naval Medical Research Center