Prospective, randomised, placebo controlled, double blind monocenter trial for the prophylactic treatment of diarrhoea with rifaximin for travellers to South- and Southeast-Asia
- Conditions
- diarrhoea of travellers to South- and Southeast-AsiaMedDRA version: 12.0Level: LLTClassification code 10021907Term: Infectious diarrhea
- Registration Number
- EUCTR2007-003986-42-DE
- Lead Sponsor
- niversity Hospital of Tübingen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 258
-Adults = 18 und < 65 years
-Good general condition (according to history)
-Written informed consent
-No pregnancy
-No breast feeding
-Efficacious contraception (hormonal conctraception, intrauterine device, condoms
or diaphragm with spermicide) during the study and 4 weeks after termination of
the study
-No participation in other clinical trials 4 weeks before, during and 4 weeks after
termination of the study
-Travel period between 6 and 28 days
-Travel to South- and Southeast Asia
-Time to arrival in the country = 24 hours
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
-Pregnancy
-Breast feeding
-Age < 18 and = 65 years
-No written informed consent
-Chronic gastrointestinal disease and / or immunoinsufficiency
-Low general condition (according to history)
-Regular medication with gastrointestinal side-effects and / or immunosuppressive
/ or lactosis
-Participation in other clinical trials 4 weeks before, during and 4 weeks after
termination of the study
- No efficacious contraception
-Travel period < 6 and > 28 days
-Travel outside South- and Southeast Asia
- Vaccination against cholera using DUKORAL within 12 months prior to inclusion
-Time to arrival in the country > 24 hours
- nown hypersensitvity against rifaximin or rifamycine-derivatives in general
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: efficacy of the prophylactic treatment with rifaximin to prevent travellers diarrhoea;Secondary Objective: toxicity of rifaximin, prevention of post infectious irritable bowel syndrome;Primary end point(s): Efficacy of the prevention of traveller´s diarhoea (by measurement of frequency and consistence of the stool as well as other gastrointestial complaints) with rifaximin<br>Toxicity of rifaximin
- Secondary Outcome Measures
Name Time Method