Prophylactic Treatment of Travellers' Diarrhoea With Rifaximin

November 7, 2013 updated by: Dr. Philipp Zanger, MD MSc DTM

Prospective, Randomised, Placebo Controlled, Double Blind Monocenter Trial for the Prophylactic Treatment of Diarrhoea With Rifaximin for Travellers to South- and Southeast-Asia

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

258

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Tübingen, Germany, 72074
        • Institute of Tropical Medicine, University Hospital of Tübingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 62 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rifaximin
Drug: Rifaximin
400 mg per day, oral use, maximum duration 28 days
Other Names:
  • Xifaxan
  • Normix
  • ATC code A07AA11
  • Chemical Abstracts Service (CAS) 80621814
Placebo Comparator: Lactose
Drug: Lactose
Coated Tablet, Oral Use

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: From the first day of the travel (travel period between 6 and 28 days) to 1 week after the subject's return to Germany
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

Outcome Measure
Time Frame
Documentation of adverse effects and tolerance of prophylaxis with rifaximin.
Time Frame: From the first day of the travel (travel period between 6 and 28 days) to 1 week after the subject's return to Germany
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.
Time Frame: From the first day of the travel (travel period between 6 and 28 days) to 6 months after the subject's return to Germany
From the first day of the travel (travel period between 6 and 28 days) to 6 months after the subject's return to Germany

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Philipp Zanger, MD MSc DTM

Investigators

  • Principal Investigator: Philipp G. Zanger, MD MSc DTM, Institute of Tropical Medicine, University Hospital of Tübingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

September 16, 2009

First Submitted That Met QC Criteria

September 16, 2009

First Posted (Estimate)

September 17, 2009

Study Record Updates

Last Update Posted (Estimate)

November 8, 2013

Last Update Submitted That Met QC Criteria

November 7, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rifa1
  • 2007-003986-42

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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