Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2025-12-25 @ 8:05 PM
Study NCT ID:
NCT02092935
Status:
COMPLETED
Last Update Posted:
2016-10-20
First Post:
2014-03-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of SMT19969 Compared With Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhoea (CDAD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003015', 'term': 'Clostridium Infections'}], 'ancestors': [{'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000601750', 'term': 'ridinilazole'}, {'id': 'D014640', 'term': 'Vancomycin'}], 'ancestors': [{'id': 'D006020', 'term': 'Glycopeptides'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'dispFirstSubmitDate': '2016-10-13', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-19', 'studyFirstSubmitDate': '2014-03-18', 'dispFirstSubmitQcDate': '2016-10-13', 'studyFirstSubmitQcDate': '2014-03-19', 'dispFirstPostDateStruct': {'date': '2016-10-17', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'To assess the qualitative and quantitative effect of SMT19969 and Vancomycin on the bowel flora of subjects', 'timeFrame': '40 days', 'description': 'Using microbiology, sequencing, metagenomic and bioinformatics techniques.'}], 'primaryOutcomes': [{'measure': 'Evaluate the clinical outcome by assessment of sustained clinical response', 'timeFrame': '30 days post End of Therapy', 'description': 'Sustained clinical response is defined as clinical cure at the Test of Cure Visit (Day 12) and no recurrence of CDAD within 30 days of End of Therapy'}], 'secondaryOutcomes': [{'measure': 'Plasma and faecal concentrations of SMT19969', 'timeFrame': '40 Days', 'description': 'Using laboratory analysis'}, {'measure': 'To assess the safety and tolerability of SMT19969 compared with vancomycin', 'timeFrame': '40 days', 'description': 'Assessment of the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported within the study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CDAD', 'Clostridium Difficile'], 'conditions': ['Clostridium Difficile Infection']}, 'referencesModule': {'references': [{'pmid': '29718329', 'type': 'DERIVED', 'citation': 'Snydman DR, McDermott LA, Thorpe CM, Chang J, Wick J, Walk ST, Vickers RJ. Antimicrobial susceptibility and ribotypes of Clostridium difficile isolates from a Phase 2 clinical trial of ridinilazole (SMT19969) and vancomycin. J Antimicrob Chemother. 2018 Aug 1;73(8):2078-2084. doi: 10.1093/jac/dky135.'}, {'pmid': '28461207', 'type': 'DERIVED', 'citation': 'Vickers RJ, Tillotson GS, Nathan R, Hazan S, Pullman J, Lucasti C, Deck K, Yacyshyn B, Maliakkal B, Pesant Y, Tejura B, Roblin D, Gerding DN, Wilcox MH; CoDIFy study group. Efficacy and safety of ridinilazole compared with vancomycin for the treatment of Clostridium difficile infection: a phase 2, randomised, double-blind, active-controlled, non-inferiority study. Lancet Infect Dis. 2017 Jul;17(7):735-744. doi: 10.1016/S1473-3099(17)30235-9. Epub 2017 Apr 28.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to evaluate the safety and effectiveness of a new oral antibiotic called SMT19969 in treating C. difficile Infection (CDI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Informed consent\n* Clinical diagnosis of CDAD plus laboratory diagnostic test\n* No more than 24 hrs antimicrobial treatment for current CDAD episode\n* No more than 3 episodes of CDAD in prior 12 months\n* No previous episode of CDAD within 30 days of study enrollment\n* Female subjects of childbearing potential must use adequate contraception\n\nExclusion Criteria:\n\n* Life-threatening or fulminant colitis\n* Concurrent use of antibiotics or any other treatments for CDAD\n* History of inflammatory bowel disease (ulcerative colitis, Crohn's disease)\n* Participation in other Clinical research studies within one month of screening"}, 'identificationModule': {'nctId': 'NCT02092935', 'briefTitle': 'A Study of SMT19969 Compared With Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhoea (CDAD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Summit Therapeutics'}, 'officialTitle': 'A Phase II, Randomized, Double-Blind, Active-Controlled Clinical Study to Investigate the Efficacy and Safety of SMT19969 Compared With Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhoea (CDAD)', 'orgStudyIdInfo': {'id': 'SMT19969/C002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SMT19969', 'description': '200 mg capsule of SMT19969 twice a day for 10 days with alternating 200 mg placebo twice a day', 'interventionNames': ['Drug: SMT19969']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vancomycin', 'description': '125 mg capsule four times a day for 10 days', 'interventionNames': ['Drug: Vancomycin']}], 'interventions': [{'name': 'SMT19969', 'type': 'DRUG', 'armGroupLabels': ['SMT19969']}, {'name': 'Vancomycin', 'type': 'DRUG', 'armGroupLabels': ['Vancomycin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'city': 'Laguna Hills', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.61252, 'lon': -117.71283}}, {'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'city': 'Sylmar', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.30778, 'lon': -118.44925}}, {'city': 'Ventura', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.27834, 'lon': -119.29317}}, {'city': 'Idaho Falls', 'state': 'Idaho', 'country': 'United States', 'geoPoint': {'lat': 43.46658, 'lon': -112.03414}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Topeka', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 39.04833, 'lon': -95.67804}}, {'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'city': 'Duluth', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 46.78327, 'lon': -92.10658}}, {'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'city': 'Tupelo', 'state': 'Mississippi', 'country': 'United States', 'geoPoint': {'lat': 34.25807, 'lon': -88.70464}}, {'city': 'Billings', 'state': 'Montana', 'country': 'United States', 'geoPoint': {'lat': 45.78329, 'lon': -108.50069}}, {'city': 'Butte', 'state': 'Montana', 'country': 'United States', 'geoPoint': {'lat': 46.00382, 'lon': -112.53474}}, {'city': 'Sommers Point', 'state': 'New Jersey', 'country': 'United States'}, {'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'city': 'Lima', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 40.74255, 'lon': -84.10523}}, {'city': 'Rapid City', 'state': 'South Dakota', 'country': 'United States', 'geoPoint': {'lat': 44.08054, 'lon': -103.23101}}, {'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Richard Vickers, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Summit (Oxford) Limited'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Summit Therapeutics', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Wellcome Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}