Prophylactic Treatment of Travellers' Diarrhoea With Rifaximin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Philipp Zanger, MD MSc DTM, University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00979056
First received: September 16, 2009
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Diarrhoea
Drug: Rifaximin
Drug: Lactose
Phase 3

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

Resource links provided by NLM:


Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 258
Study Start Date: October 2009
Study Completion Date: October 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00979056

Locations
Germany
Institute of Tropical Medicine, University Hospital of Tübingen
Tübingen, Germany, 72074
Sponsors and Collaborators
Dr. Philipp Zanger, MD MSc DTM
Investigators
Principal Investigator: Philipp G. Zanger, MD MSc DTM Institute of Tropical Medicine, University Hospital of Tübingen
  More Information

Publications:
Responsible Party: Dr. Philipp Zanger, MD MSc DTM, Oberarzt, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT00979056     History of Changes
Other Study ID Numbers: Rifa1, 2007-003986-42
Study First Received: September 16, 2009
Last Updated: November 7, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Tuebingen:
Traveller's diarrhoea
Prevention

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Rifaximin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents

ClinicalTrials.gov processed this record on April 14, 2014