Prophylactic Treatment of Travellers' Diarrhoea With Rifaximin
NCT ID: NCT00979056
Last Updated: 2013-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
258 participants
INTERVENTIONAL
2009-10-31
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Rifaximin
Rifaximin
400 mg per day, oral use, maximum duration 28 days
Lactose
Lactose
Coated Tablet, Oral Use
Interventions
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Rifaximin
400 mg per day, oral use, maximum duration 28 days
Lactose
Coated Tablet, Oral Use
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
64 Years
ALL
Yes
Sponsors
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Dr. Philipp Zanger, MD MSc DTM
OTHER
Responsible Party
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Dr. Philipp Zanger, MD MSc DTM
Oberarzt
Principal Investigators
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Philipp G. Zanger, MD MSc DTM
Role: PRINCIPAL_INVESTIGATOR
Institute of Tropical Medicine, University Hospital of Tübingen
Locations
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Institute of Tropical Medicine, University Hospital of Tübingen
Tübingen, , Germany
Countries
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References
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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.
Other Identifiers
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2007-003986-42
Identifier Type: -
Identifier Source: secondary_id
Rifa1
Identifier Type: -
Identifier Source: org_study_id