Prophylactic Treatment of Travellers' Diarrhoea With Rifaximin (NCT00979056) | Clinical Trial Compass
CompletedPhase 3
Prophylactic Treatment of Travellers' Diarrhoea With Rifaximin
Germany258 participantsStarted 2009-10
Plain-language summary
The aim of the study is to investigate the efficacy of the prophylactic treatment with rifaximin to prevent travellers diarrhoea.
Who can participate
Age range18 Years – 64 Years
SexALL
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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
What they're measuring
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.
Timeframe: From the first day of the travel (travel period between 6 and 28 days) to 1 week after the subject's return to Germany