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Prophylactic Treatment of Travellers' Diarrhoea With Rifaximin

Primary Purpose

Diarrhoea

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Rifaximin
Lactose
Sponsored by
Dr. Philipp Zanger, MD MSc DTM
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diarrhoea focused on measuring Traveller's diarrhoea, Prevention

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Institute of Tropical Medicine, University Hospital of Tübingen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Rifaximin

Lactose

Arm Description

Outcomes

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.

Secondary Outcome Measures

Documentation of adverse effects and tolerance of prophylaxis with rifaximin.
Evaluation of prevention of post infectious irritable bowel syndrome.

Full Information

First Posted
September 16, 2009
Last Updated
November 7, 2013
Sponsor
Dr. Philipp Zanger, MD MSc DTM
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1. Study Identification

Unique Protocol Identification Number
NCT00979056
Brief Title
Prophylactic Treatment of Travellers' Diarrhoea With Rifaximin
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 Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Philipp Zanger, MD MSc DTM

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the study is to investigate the efficacy of the prophylactic treatment with rifaximin to prevent travellers diarrhoea.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhoea
Keywords
Traveller's diarrhoea, Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
258 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rifaximin
Arm Type
Experimental
Arm Title
Lactose
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Rifaximin
Other Intervention Name(s)
Xifaxan, Normix, ATC code A07AA11, Chemical Abstracts Service (CAS) 80621814
Intervention Description
400 mg per day, oral use, maximum duration 28 days
Intervention Type
Drug
Intervention Name(s)
Lactose
Intervention Description
Coated Tablet, Oral Use
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philipp G. Zanger, MD MSc DTM
Organizational Affiliation
Institute of Tropical Medicine, University Hospital of Tübingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Tropical Medicine, University Hospital of Tübingen
City
Tübingen
ZIP/Postal Code
72074
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
24012319
Citation
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.
Results Reference
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Prophylactic Treatment of Travellers' Diarrhoea With Rifaximin

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