Prophylactic Treatment of Travellers' Diarrhoea With Rifaximin

Diarrhoea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00979056
• Other study ID #: Rifa1
• Secondary ID: 2007-003986-42
• Status: Completed
• Phase: Phase 3
• First received: September 16, 2009
• Last updated: November 7, 2013
• Start date: October 2009
• Est. completion date: October 2012

Study information

• Verified date: November 2013
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: October 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diarrhea
• Diarrhoea

Intervention

Drug:
• Rifaximin
400 mg per day, oral use, maximum duration 28 days
• Lactose
Coated Tablet, Oral Use

Locations

Country	Name	City	State
Germany	Institute of Tropical Medicine, University Hospital of Tübingen	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Philipp Zanger, MD MSc DTM

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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( — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		From the first day of the travel (travel period between 6 and 28 days) to 1 week after the subject's return to Germany	No
Secondary	Documentation of adverse effects and tolerance of prophylaxis with rifaximin.		From the first day of the travel (travel period between 6 and 28 days) to 1 week after the subject's return to Germany	Yes
Secondary	Evaluation of prevention of post infectious irritable bowel syndrome.		From the first day of the travel (travel period between 6 and 28 days) to 6 months after the subject's return to Germany	No