Prophylactic Treatment of Travellers' Diarrhoea With Rifaximin

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dr. Philipp Zanger, MD MSc DTM
• Treatments: Rifamycins; Rifaximin

Criteria

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