Prophylactic Treatment of Travellers' Diarrhoea With Rifaximin

Dr. Philipp Zanger, MD MSc DTM

Status and phase

Completed

Phase 3

Conditions

Diarrhoea

Treatments

Drug: Rifaximin

Drug: Lactose

Study type

Interventional

Funder types

Other

Identifiers

2007-003986-42

Rifa1

Details and patient eligibility

About

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

Enrollment

258 patients

Sex

All

Ages

18 to 64 years old

Volunteers

Accepts Healthy Volunteers

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