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Prophylactic Treatment of Travellers' Diarrhoea With Rifaximin

Sponsor
Dr. Philipp Zanger, MD MSc DTM (Other)
Overall Status
Completed
CT.gov ID
NCT00979056
Collaborator
(none)
258
Enrollment
1
Location
2
Arms
36
Duration (Months)
7.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the study is to investigate the efficacy of the prophylactic treatment with rifaximin to prevent travellers diarrhoea.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
258 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
Prospective, Randomised, Placebo Controlled, Double Blind Monocenter Trial for the Prophylactic Treatment of Diarrhoea With Rifaximin for Travellers to South- and Southeast-Asia
Study Start Date :
Oct 1, 2009
Actual Primary Completion Date :
Mar 1, 2012
Actual Study Completion Date :
Oct 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Rifaximin

Drug: Rifaximin
400 mg per day, oral use, maximum duration 28 days
Other Names:
  • Xifaxan
  • Normix
  • ATC code A07AA11
  • Chemical Abstracts Service (CAS) 80621814

    		•
    Placebo Comparator: Lactose

    Drug: Lactose
    Coated Tablet, Oral Use

    Outcome Measures

    Primary Outcome Measures

    1. Efficacy of the prevention of travellers diarrhea with rifaximin by measurement of frequency and consistence of the stool. Diarrhea will be defined as passage of >2 unformed stools/24 hr plus one or more signs or symptoms of enteric infection. [From the first day of the travel (travel period between 6 and 28 days) to 1 week after the subject's return to Germany]

    Secondary Outcome Measures

    1. Documentation of adverse effects and tolerance of prophylaxis with rifaximin. [From the first day of the travel (travel period between 6 and 28 days) to 1 week after the subject's return to Germany]

    2. Evaluation of prevention of post infectious irritable bowel syndrome. [From the first day of the travel (travel period between 6 and 28 days) to 6 months after the subject's return to Germany]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 64 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Adults ≥ 18 and < 65 years

    • Good general condition (according to history and clinical examination)

    • Written informed consent

    • No pregnancy

    • No breast feeding

    • Efficacious contraception (e.g. oral, double-barrier) during the study and 4 weeks after termination of the study

    • No participation in other clinical trials 4 weeks before, during participation, and 4 weeks after participation in this study

    • Planned travel period between 6 and 28 days

    • Planned travel to South- and Southeast Asia

    • Planned time to arrival in South- or Southeast Asia ≤ 24 hours

    Exclusion Criteria:

    • Pregnancy

    • Breast feeding

    • Age < 18 and ≥ 65 years

    • No written informed consent

    • Chronic gastrointestinal disease and/ or immune insufficiency

    • Low general condition (according to history and clinical examination)

    • Regular medication with gastrointestinal side-effects and/or immunosuppressive medication

    • Participation in other clinical trials 4 weeks before, during and 4 weeks after termination of the study

    • No efficacious contraception

    • Planned travel period < 6 and > 28 days

    • Planned travel outside South- and Southeast Asia

    • Vaccination against cholera using DUKORAL within 12 months prior to inclusion

    • Planned time to arrival in South- or Southeast Asia > 24 hours

    • Known hypersensitivity against rifaximin or rifamycin-derivatives in general

    • Known lactose intolerance

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Institute of Tropical Medicine, University Hospital of Tübingen Tübingen Germany 72074

    Sponsors and Collaborators

    • Dr. Philipp Zanger, MD MSc DTM

    Investigators

    • Principal Investigator: Philipp G. Zanger, MD MSc DTM, Institute of Tropical Medicine, University Hospital of Tübingen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Philipp Zanger, MD MSc DTM, Oberarzt, University Hospital Tuebingen
    ClinicalTrials.gov Identifier:
    NCT00979056
    Other Study ID Numbers:
    • Rifa1
    • 2007-003986-42
    First Posted:
    Sep 17, 2009
    Last Update Posted:
    Nov 8, 2013
    Last Verified:
    Nov 1, 2013
    Keywords provided by Dr. Philipp Zanger, MD MSc DTM, Oberarzt, University Hospital Tuebingen
    Traveller's diarrhoea
    Prevention
    Additional relevant MeSH terms:
    Diarrhea
    Rifaximin

    Study Results

    No Results Posted as of Nov 8, 2013