Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00979056
Other study ID # Rifa1
Secondary ID 2007-003986-42
Status Completed
Phase Phase 3
First received September 16, 2009
Last updated November 7, 2013
Start date October 2009
Est. completion date October 2012

Study information

Verified date November 2013
Source University Hospital Tuebingen
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 258
Est. completion date October 2012
Est. primary completion date March 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 64 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Rifaximin
400 mg per day, oral use, maximum duration 28 days
Lactose
Coated Tablet, Oral Use

Locations

Country Name City State
Germany Institute of Tropical Medicine, University Hospital of Tübingen Tübingen

Sponsors (1)

Lead Sponsor Collaborator
Dr. Philipp Zanger, MD MSc DTM

Country where clinical trial is conducted

Germany, 

References & 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( — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 Yes
Secondary 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 No
See also
  Status Clinical Trial Phase
Completed NCT01214785 - Cluster Randomised Trial of Improved Sanitation in Rural Orissa, India N/A
Recruiting NCT05073003 - A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants Phase 1/Phase 2
Completed NCT01969214 - Safety and Efficacy of IQP-MM-101 in Reducing Symptoms of Diarrhoea N/A
Completed NCT01202383 - Double-blinded Trial of Household-based Chlorination in India Phase 3
Completed NCT01087892 - Probiotics in Preventing Antibiotic Associated Diarrhoea Including Clostridium Difficile Infection N/A
Completed NCT02072629 - HCU: Can VHVs Trained in ICCM Improve Care for Children N/A
Completed NCT00408356 - Immunological and Clinical Responses to Zinc in Children With Diarrhoea Phase 3
Completed NCT01517230 - Can Mass Media Campaigns Reduce Child Mortality N/A
Completed NCT02858609 - Improving the Diagnosis of Diarrhoea in Emergency Rooms N/A
Completed NCT01306383 - Solar Disinfection (SODIS) of Drinking Water for Use in Developing Countries or in Emergency Situations N/A
Completed NCT00352716 - Effectiveness of Smecta in the Treatment of Acute Diarrhoea in Children Phase 3
Active, not recruiting NCT02606526 - Early Versus Late BCG Vaccination in HIV-1 Exposed Infants in Uganda in Uganda Phase 3
Completed NCT00352989 - Effectiveness of Smecta in Combination With Oral Rehydration in the Treatment of Acute Watery Diarrhoea in Infants and Children Phase 3
Completed NCT00324285 - Oral Rehydration SolutionContaining Amylase Resistant Starch in Severely Malnourished Children. Phase 3
Recruiting NCT02144168 - The Effect of Enteral Nutrition Supplemented With Prebiotics on Colonic Microbiota in the Critically Ill Patients N/A
Withdrawn NCT01491659 - A Study to Evaluate the Effect and Safety of Idoform Plus on Bowel Side Effects in Healthy Subjects Treated With Amoxicillin/ Clavulanate Phase 4
Completed NCT02797353 - Strengthening Maternal Neonatal and Child Health Services in a Rural District of Pakistan N/A
Completed NCT01557673 - Effects of Bolus and Continuous Nasogastric Feeding on Small Bowel Water Content and Blood Flow Phase 1/Phase 2
Completed NCT00823056 - The Effect of Probiotics on Infections in Toddlers Phase 3
Completed NCT01154803 - Effectiveness of Nutritional Supplementation in Preventing Malnutrition in Children With Infection N/A