Status:
COMPLETED
Prophylactic Treatment of Travellers' Diarrhoea With Rifaximin
Lead Sponsor:
Dr. Philipp Zanger, MD MSc DTM
Conditions:
Diarrhoea
Eligibility:
All Genders
18-64 years
Phase:
PHASE3
Brief Summary
The aim of the study is to investigate the efficacy of the prophylactic treatment with rifaximin to prevent travellers diarrhoea.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
258 Patients enrolled
Trial Details
Trial ID
NCT00979056
Start Date
October 1 2009
End Date
October 1 2012
Last Update
November 8 2013
Active Locations (1)
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1
Institute of Tropical Medicine, University Hospital of Tübingen
Tübingen, Germany, 72074