Trial Evaluating Chemoprophylaxis Against Travelers' Diarrhea - Prevent TD

NCT02498301 | Completed

• 1 other identifier: IDCRP-080
• Study Type: interventional
• Target: 449
• Locations: 2 countries
• Sites: 6

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.

Conditions

Travelers' Diarrhea; Functional Bowel Disorders; Reactive Arthritis

Keywords

travelers' diarrhea; military; enteric illness; gastrointestinal

Outcome Measures

Primary Outcomes (1)

• Efficacy - Risk of travelers diarrhea during chemoprophylaxis as measured by self-report via use of a memory aid

  24hr

Secondary Outcomes (2)

• Efficacy as determined by use of a symptom memory aid.

  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

  For the duration of prophylaxis which will be on average 3-4 weeks or a maximum of 6 weeks.

Study Arms (3)

Rifaximin 550 mg once/day

EXPERIMENTAL

rifaximin, 550 mg, once daily, by mouth

Drug: Rifaximin

Rifaximin 550 mg twice/day

EXPERIMENTAL

rifaximin, 550 mg, twice daily, by mouth

Drug: Rifaximin; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Placebo pills, twice daily, by mouth

Drug: Placebo

Interventions

Rifaximin DRUG

Rifaximin will be provided to subjects either daily with placebo, or twice daily depending on which of the two experimental arms they are randomized to

Also known as: Xifaxan

Rifaximin 550 mg once/day; Rifaximin 550 mg twice/day

Placebo DRUG

Placebo will be administered twice daily or once daily with rifaximin depending on which experimental arm they are randomized to

Placebo; Rifaximin 550 mg twice/day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• An Institutional Review Board (IRB) / Ethics Committee (EC)-approved informed consent form is signed and dated.
• Subject is at least 18 years of age
• Subject's duration of prophylaxis will be least 2 weeks.
• 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).
• 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.
• (For US Personnel Only). Have consented to participate in TravMil protocol.

You may not qualify if:

• Subject received any systemic or gastrointestinal antibiotic in the 7 days prior to enrollment (except anti-malarial prophylaxis agents).
• Subject has hypersensitivity or allergy to rifaximin or rifampicin.
• Subject has acute diarrhea within 7 days prior to enrollment
• 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
• Subject is currently taking or plans to take during deployment at least one of the following medications: theophylline or warfarin (Coumadin).

Sponsors & Collaborators

• Henry M. Jackson Foundation for the Advancement of Military Medicine: lead
• Naval Medical Research Center: collaborator
• Ministry of Defence, United Kingdom: collaborator

Study Sites (6)

Naval Medical Center San Diego

San Diego, California, 92134, United States

Location

Tripler Army Medical Center/Schofield Barracks

Honolulu, Hawaii, 96786, United States

Location

Naval Hospital Camp Lejeune

Marine Corps Base Camp Lejeune, North Carolina, 28547, United States

Location

San Antonio Military Medical Center

San Antonio, Texas, 78234, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

British Army Training Unit Kenya

Nanyuki, Kenya

Location

MeSH Terms

Conditions

Arthritis, Reactive

Interventions

Rifaximin

Condition Hierarchy (Ancestors)

Arthritis, Infectious; Infections; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Ramiro Gutierrez, MD

  Naval Medical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2015
• First Posted: July 15, 2015
• Study Start: November 10, 2015
• Primary Completion: July 1, 2019
• Study Completion: December 31, 2019
• Last Updated: February 15, 2023

Record last verified: 2021-11

Locations

US (5); KE (1)