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

September 16, 2009
November 7, 2013
October 2009
March 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00979056 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Prophylactic Treatment of Travellers' Diarrhoea With Rifaximin
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Diarrhoea
  • Drug: Rifaximin
    400 mg per day, oral use, maximum duration 28 days
    Other Names:
    • Xifaxan
    • Normix
    • ATC code A07AA11
    • Chemical Abstracts Service (CAS) 80621814
  • Drug: Lactose
    Coated Tablet, Oral Use
  • Experimental: Rifaximin
    Intervention: Drug: Rifaximin
  • Placebo Comparator: Lactose
    Intervention: Drug: Lactose
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(11):946-54. doi: 10.1016/S1473-3099(13)70221-4. Epub 2013 Sep 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
258
October 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 64 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00979056
Rifa1, 2007-003986-42
No
Dr. Philipp Zanger, MD MSc DTM, University Hospital Tuebingen
Dr. Philipp Zanger, MD MSc DTM
Not Provided
Principal Investigator: Philipp G. Zanger, MD MSc DTM Institute of Tropical Medicine, University Hospital of Tübingen
University Hospital Tuebingen
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP