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

Sponsor:	University Hospital Tuebingen
Information provided by:	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: Lactulose	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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 Giardia Infections

Drug Information available for: Rifaximin Lactulose

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 ]

Estimated Enrollment:	258
Study Start Date:	October 2009
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Rifaximin: Experimental	Drug: Rifaximin 400 mg per day, oral use, maximum duration 28 days
Lactulose: Placebo Comparator	Drug: Lactulose 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, 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 immune insufficiency
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00979056

Contacts

Contact: Philipp G. Zanger, MD DTM DEpi

+49 7971 29-82365

Locations

Germany
Institute of Tropical Medicine, University Hospital of Tübingen	Recruiting
Tübingen, Germany, 72074
Contact: Philipp G. Zanger, MD DTM DEpi +49 7071 29-82365 philipp.zanger@med.uni-tuebingen.de
Principal Investigator: Philipp G. Zanger, MD DTM DEpi

Sponsors and Collaborators

University Hospital Tuebingen

Investigators

Principal Investigator:

Philipp G. Zanger, MD DTM DEpi

Institute of Tropical Medicine, University Hospital of Tübingen

More Information

No publications provided

Responsible Party:	University Hospital Tuebingen ( MD Philipp Günter Zanger )
Study ID Numbers:	Rifa1, 2007-003986-42
Study First Received:	September 16, 2009
Last Updated:	November 12, 2009
ClinicalTrials.gov Identifier:	NCT00979056 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:

Anti-Infective Agents
Signs and Symptoms
Diarrhea
Signs and Symptoms, Digestive
Therapeutic Uses

Gastrointestinal Agents
Rifaximin
Pharmacologic Actions
Lactulose

ClinicalTrials.gov processed this record on February 08, 2010