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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014