Prophylactic Treatment of Travellers' Diarrhoea With Rifaximin
Information source: University Hospital Tuebingen
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diarrhoea
Intervention: Rifaximin (Drug); Lactulose (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: University Hospital Tuebingen Official(s) and/or principal investigator(s):
Philipp G. Zanger, MD DTM DEpi, Principal Investigator, Affiliation: Institute of Tropical Medicine, University Hospital of Tübingen
Overall contact:
Philipp G. Zanger, MD DTM DEpi, Phone: +49 7971 29-82365, Email: philipp.zanger@med.uni-tuebingen.de
Summary
The aim of the study is to investigate the efficacy of the prophylactic treatment with
rifaximin to prevent travellers diarrhoea.
Clinical Details
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
Study design: Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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.
Secondary outcome: Documentation of adverse effects and tolerance of prophylaxis with rifaximin.Evaluation of prevention of post infectious irritable bowel syndrome.
Eligibility
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Both.
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, condoms) during the study and 4 weeks after
termination of the study
- No participation in other clinical trials 4 weeks before, during and 4 weeks after
termination of the study
- Travel period between 6 and 28 days
- Travel to South- and Southeast Asia
- Time to arrival in the country ≤ 24 hours
Exclusion Criteria:
- Pregnancy
- Breast feeding
- Age < 18 and ≥ 65 years
- No written informed consent
- Chronic gastrointestinal disease and/ or immunoinsufficiency
- Low general condition (according to history and clinical examination)
- Regular medication with gastrointestinal side-effects and/ or immunosuppressive/ or
lactosis
- Participation in other clinical trials 4 weeks before, during and 4 weeks after
termination of the study
- No efficacious contraception
- Travel period < 6 and > 28 days
- Travel outside South- and Southeast Asia
- Vaccination against cholera using DUKORAL within 12 months prior to inclusion
- Time to arrival in the country > 24 hours
- Known hypersensitivity against rifaximin or rifamycin-derivates in general
Locations and Contacts
Philipp G. Zanger, MD DTM DEpi, Phone: +49 7971 29-82365, Email: philipp.zanger@med.uni-tuebingen.de
Institute of Tropical Medicine, University Hospital of Tübingen, Tübingen 72074, Germany
Additional Information
Starting date: September 2009
Ending date: March 2011
Last updated: September 16, 2009
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