Prophylactic Treatment of Travellers' Diarrhoea With Rifaximin

Phase 3

Completed

• Conditions: Diarrhoea
• Interventions: Drug: Rifaximin; Drug: Lactose

• Registration Number: NCT00979056
• Lead Sponsor: Dr. Philipp Zanger, MD MSc DTM

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-09-16
• Study First Submitted QC: 2009-09-16
• Study First Posted: 2009-09-17
• Study Start: 2009-10
• Primary Completion: 2012-03
• Study Completion: 2012-10
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-07
• Last Update Posted: 2013-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 258

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rifaximin	Rifaximin	-
Lactose	Lactose	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Institute of Tropical Medicine, University Hospital of Tübingen; 🇩🇪 Tübingen, Germany