Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2026-02-11 @ 7:00 AM
Study NCT ID:
NCT00979056
Status:
COMPLETED
Last Update Posted:
2013-11-08
First Post:
2009-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prophylactic Treatment of Travellers' Diarrhoea With Rifaximin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003967', 'term': 'Diarrhea'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078262', 'term': 'Rifaximin'}, {'id': 'D007785', 'term': 'Lactose'}], 'ancestors': [{'id': 'D012294', 'term': 'Rifamycins'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D047029', 'term': 'Lactams, Macrocyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004187', 'term': 'Disaccharides'}, {'id': 'D009844', 'term': 'Oligosaccharides'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D000073893', 'term': 'Sugars'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 258}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-07', 'studyFirstSubmitDate': '2009-09-16', 'studyFirstSubmitQcDate': '2009-09-16', 'lastUpdatePostDateStruct': {'date': '2013-11-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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.', 'timeFrame': "From the first day of the travel (travel period between 6 and 28 days) to 1 week after the subject's return to Germany"}], 'secondaryOutcomes': [{'measure': 'Documentation of adverse effects and tolerance of prophylaxis with rifaximin.', 'timeFrame': "From the first day of the travel (travel period between 6 and 28 days) to 1 week after the subject's return to Germany"}, {'measure': 'Evaluation of prevention of post infectious irritable bowel syndrome.', 'timeFrame': "From the first day of the travel (travel period between 6 and 28 days) to 6 months after the subject's return to Germany"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Traveller's diarrhoea", 'Prevention'], 'conditions': ['Diarrhoea']}, 'referencesModule': {'references': [{'pmid': '24012319', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to investigate the efficacy of the prophylactic treatment with rifaximin to prevent travellers diarrhoea.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults ≥ 18 and \\< 65 years\n* Good general condition (according to history and clinical examination)\n* Written informed consent\n* No pregnancy\n* No breast feeding\n* Efficacious contraception (e.g. oral, double-barrier) during the study and 4 weeks after termination of the study\n* No participation in other clinical trials 4 weeks before, during participation, and 4 weeks after participation in this study\n* Planned travel period between 6 and 28 days\n* Planned travel to South- and Southeast Asia\n* Planned time to arrival in South- or Southeast Asia ≤ 24 hours\n\nExclusion Criteria:\n\n* Pregnancy\n* Breast feeding\n* Age \\< 18 and ≥ 65 years\n* No written informed consent\n* Chronic gastrointestinal disease and/ or immune insufficiency\n* Low general condition (according to history and clinical examination)\n* Regular medication with gastrointestinal side-effects and/or immunosuppressive medication\n* Participation in other clinical trials 4 weeks before, during and 4 weeks after termination of the study\n* No efficacious contraception\n* Planned travel period \\< 6 and \\> 28 days\n* Planned travel outside South- and Southeast Asia\n* Vaccination against cholera using DUKORAL within 12 months prior to inclusion\n* Planned time to arrival in South- or Southeast Asia \\> 24 hours\n* Known hypersensitivity against rifaximin or rifamycin-derivatives in general\n* Known lactose intolerance'}, 'identificationModule': {'nctId': 'NCT00979056', 'briefTitle': "Prophylactic Treatment of Travellers' Diarrhoea With Rifaximin", 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'Prospective, Randomised, Placebo Controlled, Double Blind Monocenter Trial for the Prophylactic Treatment of Diarrhoea With Rifaximin for Travellers to South- and Southeast-Asia', 'orgStudyIdInfo': {'id': 'Rifa1'}, 'secondaryIdInfos': [{'id': '2007-003986-42'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rifaximin', 'interventionNames': ['Drug: Rifaximin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Lactose', 'interventionNames': ['Drug: Lactose']}], 'interventions': [{'name': 'Rifaximin', 'type': 'DRUG', 'otherNames': ['Xifaxan', 'Normix', 'ATC code A07AA11', 'Chemical Abstracts Service (CAS) 80621814'], 'description': '400 mg per day, oral use, maximum duration 28 days', 'armGroupLabels': ['Rifaximin']}, {'name': 'Lactose', 'type': 'DRUG', 'description': 'Coated Tablet, Oral Use', 'armGroupLabels': ['Lactose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72074', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'Institute of Tropical Medicine, University Hospital of Tübingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}], 'overallOfficials': [{'name': 'Philipp G. Zanger, MD MSc DTM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Tropical Medicine, University Hospital of Tübingen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Philipp Zanger, MD MSc DTM', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Oberarzt', 'investigatorFullName': 'Dr. Philipp Zanger, MD MSc DTM', 'investigatorAffiliation': 'University Hospital Tuebingen'}}}}