Prophylactic Treatment of Travellers' Diarrhoea With Rifaximin - Full Text View

Sponsor:	Dr. Philipp Zanger, MD MSc DTM
Information provided by (Responsible Party):	Dr. Philipp Zanger, MD MSc DTM, University Hospital Tuebingen
ClinicalTrials.gov Identifier:	NCT00979056

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:

MedlinePlus related topics: Diarrhea

Drug Information available for: Rifaximin

U.S. FDA Resources

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
Estimated 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

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

No publications provided

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:	March 19, 2012
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 May 24, 2012