Trial Evaluating Chemoprophylaxis Against Travelers' Diarrhea - Prevent TD

• Register: ClinicalTrials.gov
• Last refreshed on: 27 February 2023
• Main ID: NCT02498301
• Date of registration: 06/07/2015
• Prospective Registration: Yes
• Primary sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
• Public title: Trial Evaluating Chemoprophylaxis Against Travelers' Diarrhea - Prevent TD
• Scientific 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) Among Active Duty Deployed U.S. and British Military Personnel
• Date of first enrolment: November 10, 2015
• Target sample size: 449
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02498301
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Kenya, United States

Contacts

• Name: Ramiro Gutierrez, MD
• Affiliation: Naval Medical Research Center

Key inclusion & exclusion criteria

Inclusion Criteria:

1. An Institutional Review Board (IRB) / Ethics Committee (EC)-approved informed consent
form is signed and dated.

2. Subject is at least 18 years of age

3. Subject's duration of prophylaxis will be least 2 weeks.

4. Subject is capable of and willing to comply with all study procedures and available
for the end of study visits and sample collection at COO (within 6 months from start
of prophylaxis).

5. Women: Non-nursing and negative urine/serum pregnancy test with understanding (through
informed consent process) to avoid pregnancy while on study drug. Sole reliance on
oral contraceptives (OCPs) for birth control will not be recommended (see section
6.3.2.1.) Should an individual have a documented surgical sterilization in her medical
record, a pregnancy test will not be required. If a volunteer becomes pregnant during
the study, the principal investigator will notify the study research monitor and the
IRBs. The pregnancy outcome will be followed per IRB and other regulatory requirements
for US and UK personnel.

6. (For US Personnel Only). Have consented to participate in TravMil protocol.

Exclusion Criteria:

1. Subject received any systemic or gastrointestinal antibiotic in the 7 days prior to
enrollment (except anti-malarial prophylaxis agents).

2. Subject has hypersensitivity or allergy to rifaximin or rifampicin.

3. Subject has acute diarrhea within 7 days prior to enrollment

4. Subject has a concomitant disease or condition that could interfere with, or for which
treatment could interfere with, the conduct of the study, or could in the opinion of
the investigator increase the risk of AEs during the subject's participation in the
study

5. Subject is currently taking or plans to take during deployment at least one of the
following medications: theophylline or warfarin (Coumadin).



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Functional Bowel Disorders

Reactive Arthritis

Travelers' Diarrhea

Intervention(s)

Drug: Placebo

Drug: Rifaximin

Primary Outcome(s)

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

Secondary Outcome(s)

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]

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.]

Secondary ID(s)

IDCRP-080

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ministry of Defence, United Kingdom

Naval Medical Research Center