Prophylactic Treatment of Travellers' Diarrhoea With Rifaximin

NCT00979056 | Completed Phase 3

• 2 other identifiers: Rifa12007-003986-42
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diarrhoea

Keywords

Traveller's diarrhoea; Prevention

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (2)

• Documentation of adverse effects and tolerance of prophylaxis with rifaximin.

  From the first day of the travel (travel period between 6 and 28 days) to 1 week after the subject's return to Germany

• Evaluation of prevention of post infectious irritable bowel syndrome.

  From the first day of the travel (travel period between 6 and 28 days) to 6 months after the subject's return to Germany

Study Arms (2)

Rifaximin

EXPERIMENTAL

Drug: Rifaximin

Lactose

PLACEBO COMPARATOR

Drug: Lactose

Interventions

Rifaximin DRUG

400 mg per day, oral use, maximum duration 28 days

Also known as: Xifaxan, Normix, ATC code A07AA11, Chemical Abstracts Service (CAS) 80621814

Rifaximin

Lactose DRUG

Coated Tablet, Oral Use

Lactose

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• Planned time to arrival in South- or Southeast Asia \> 24 hours
• Known hypersensitivity against rifaximin or rifamycin-derivatives in general
• Known lactose intolerance

Sponsors & Collaborators

• Dr. Philipp Zanger, MD MSc DTM: lead

Study Sites (1)

Institute of Tropical Medicine, University Hospital of Tübingen

Tübingen, 72074, Germany

Location

Related Publications (1)

• 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.

  PMID: 24012319 RESULT

MeSH Terms

Conditions

Diarrhea

Interventions

Rifaximin; Lactose

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Philipp G. Zanger, MD MSc DTM

  Institute of Tropical Medicine, University Hospital of Tübingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Oberarzt

Study Record Dates

• First Submitted: September 16, 2009
• First Posted: September 17, 2009
• Study Start: October 1, 2009
• Primary Completion: March 1, 2012
• Study Completion: October 1, 2012
• Last Updated: November 8, 2013

Record last verified: 2013-11

Locations

DE (1)