Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Trial Evaluating Chemoprophylaxis Against Travelers' Diarrhea - Prevent TD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02498301
Recruitment Status : Active, not recruiting
First Posted : July 15, 2015
Last Update Posted : November 27, 2019
Sponsor:
Collaborators:
Naval Medical Research Center
Ministry of Defence, United Kingdom
Information provided by (Responsible Party):
Ramiro Gutierrez, Naval Medical Research Center

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.


Condition or disease Intervention/treatment Phase
Travelers' Diarrhea Functional Bowel Disorders Reactive Arthritis Drug: Rifaximin Drug: Placebo Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 449 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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) Among Active Duty Deployed U.S. and British Military Personnel
Actual Study Start Date : November 10, 2015
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
Drug Information available for: Rifaximin

Arm Intervention/treatment
Experimental: Rifaximin 550 mg once/day
rifaximin, 550 mg, once daily, by mouth
Drug: Rifaximin
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
Other Name: Xifaxan

Experimental: Rifaximin 550 mg twice/day
rifaximin, 550 mg, twice daily, by mouth
Drug: Rifaximin
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
Other Name: Xifaxan

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

Placebo Comparator: Placebo
Placebo pills, twice daily, by mouth
Drug: Placebo
Placebo will be administered twice daily or once daily with rifaximin depending on which experimental arm they are randomized to




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

Secondary Outcome Measures :
  1. 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

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02498301


Locations
Layout table for location information
United States, California
Naval Medical Center San Diego
San Diego, California, United States, 92134
United States, Hawaii
Tripler Army Medical Center/Schofield Barracks
Honolulu, Hawaii, United States, 96786
United States, North Carolina
Naval Hospital Camp Lejeune
Camp Lejeune, North Carolina, United States, 28547
United States, Texas
San Antonio Military Medical Center
San Antonio, Texas, United States, 78234
United States, Washington
Madigan Army Medical Center
Tacoma, Washington, United States, 98431
Kenya
British Army Training Unit Kenya
Nanyuki, Kenya
Sponsors and Collaborators
Uniformed Services University of the Health Sciences
Naval Medical Research Center
Ministry of Defence, United Kingdom
Investigators
Layout table for investigator information
Principal Investigator: Ramiro Gutierrez, MD Naval Medical Research Center

Layout table for additonal information
Responsible Party: Ramiro Gutierrez, Head, Enteric Diseases Department, Naval Medical Research Center
ClinicalTrials.gov Identifier: NCT02498301    
Other Study ID Numbers: IDCRP-080
First Posted: July 15, 2015    Key Record Dates
Last Update Posted: November 27, 2019
Last Verified: November 2019
Keywords provided by Ramiro Gutierrez, Naval Medical Research Center:
travelers' diarrhea
military
enteric illness
gastrointestinal
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis, Reactive
Dysentery
Intestinal Diseases
Diarrhea
Arthritis
Joint Diseases
Musculoskeletal Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Arthritis, Infectious
Infection
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Rifaximin
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents