Clinical trial NCT00979056: Prophylactic Treatment of Travellers' Diarrhoea With Rifaximin
Official title: Prospective, Randomised, Placebo Controlled, Double Blind Monocenter Trial for the Prophylactic Treatment of Diarrhoea With Rifaximin for Travellers to South- and Southeast-Asia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diarrhoea
Keywords: Traveller's diarrhoea
Prevention
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2009-09-17
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Documentation of adverse effects and tolerance of prophylaxis with rifaximin.
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
measure: Evaluation of prevention of post infectious irritable bowel syndrome.
timeFrame: From the first day of the travel (travel period between 6 and 28 days) to 6 months after the subject's return to Germany
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Institute of Tropical Medicine, University Hospital of Tübingen
Study officials:
affiliation: Institute of Tropical Medicine, University Hospital of Tübingen
name: Philipp G. Zanger, MD MSc DTM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zanger P, Nurjadi D, Gabor J, Gaile M, Kremsner PG. Effectiveness of rifaximin in prevention of diarrhoea in individuals travelling to south and southeast Asia: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Infect Dis. 2013 Nov;13(11):946-54. doi: 10.1016/S1473-3099(13)70221-4. Epub 2013 Sep 4.