Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-03-02 @ 3:42 PM
Study NCT ID:
NCT02784002
Status:
COMPLETED
Last Update Posted:
2017-10-12
First Post:
2016-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Ridinilazole (SMT19969) Compared With Fidaxomicin for the Treatment of Clostridium Difficile Infection (CDI)
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': 'D000077732', 'term': 'Fidaxomicin'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'dispFirstSubmitDate': '2017-10-03', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-03', 'studyFirstSubmitDate': '2016-05-16', 'dispFirstSubmitQcDate': '2017-10-03', 'studyFirstSubmitQcDate': '2016-05-23', 'dispFirstPostDateStruct': {'date': '2017-10-12', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2017-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of treatment emergent adverse events (AEs) and serious adverse events (SAEs) to evaluate safety and tolerability', 'timeFrame': '30 days post End of Therapy'}], 'secondaryOutcomes': [{'measure': 'To assess the pharmacokinetics of SMT19969 in patients with CDI by measuring the plasma, urine and fecal concentrations of SMT19969', 'timeFrame': '12 days'}, {'measure': 'To assess the qualitative and quantitative effect on the bowel flora of each subject using 16S ribosomal RNA sequencing, metagenomics and bioinformatic techniques', 'timeFrame': '40 days'}, {'measure': 'Measure clinical cure rates at the Test of Cure (TOC) visit', 'timeFrame': '12 days', 'description': 'Investigator assessed clinical response at the TOC visit (on day 12) with clinical cure defined as the resolution of diarrhoea (≤ 3 Unformed Bowel Movements (UBMs) per day) while on treatment that is maintained until the TOC visit.'}, {'measure': 'Measure sustained clinical response (SCR) rates', 'timeFrame': '40 days', 'description': 'SCR is defined as clinical cure at TOC and no recurrence of CDI within 30 days post end of treatment (EOT).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Clostridium Difficile Infection']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to evaluate the safety and effectiveness of Ridinilazole (SMT19969) in treating C. difficile Infection (CDI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed Consent\n* Clinical diagnosis of CDI plus laboratory diagnostic test\n* No more than 30 hours antimicrobial treatment for current CDI episode\n* Female subjects of childbearing potential must use adequate contraception\n\nExclusion Criteria:\n\n* Life-threatening or fulminant CDI\n* Subjects with 2 or more episodes of CDI in the previous year\n* Females who are pregnant or breastfeeding\n* History of inflammatory bowel disease\n* Co-administration of potent P-glycoprotein inhibitors\n* Participation in other Clinical research studies within one month of screening\n* Subjects that the Investigator feels are inappropriate for the study'}, 'identificationModule': {'nctId': 'NCT02784002', 'briefTitle': 'A Study of Ridinilazole (SMT19969) Compared With Fidaxomicin for the Treatment of Clostridium Difficile Infection (CDI)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Summit Therapeutics'}, 'officialTitle': 'A Phase II, Randomized, Open-Label, Active-Controlled Clinical Study to Investigate the Safety and Efficacy of SMT19969 (200mg BID) for 10 Days Compared With Fidaxomicin (200 mg BID) for 10 Days for the Treatment of Clostridium Difficile Infection (CDI)', 'orgStudyIdInfo': {'id': 'SMT19969/C003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ridinilazole (SMT19969)', 'description': '200 mg capsule of Ridinilazole (SMT19969) twice a day for 10 days', 'interventionNames': ['Drug: Ridinilazole']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fidaxomicin', 'description': '200 mg tablet of Fidaxomicin twice a day for 10 days', 'interventionNames': ['Drug: Fidaxomicin']}], 'interventions': [{'name': 'Ridinilazole', 'type': 'DRUG', 'otherNames': ['SMT19969'], 'armGroupLabels': ['Ridinilazole (SMT19969)']}, {'name': 'Fidaxomicin', 'type': 'DRUG', 'armGroupLabels': ['Fidaxomicin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92653', 'city': 'Laguna Hills', 'state': 'California', 'country': 'United States', 'facility': 'Laguna Hills', 'geoPoint': {'lat': 33.61252, 'lon': -117.71283}}, {'zip': '93003', 'city': 'Ventura', 'state': 'California', 'country': 'United States', 'facility': 'Ventura', 'geoPoint': {'lat': 34.27834, 'lon': -119.29317}}, {'zip': '83404', 'city': 'Idaho Falls', 'state': 'Idaho', 'country': 'United States', 'facility': 'Idaho', 'geoPoint': {'lat': 43.46658, 'lon': -112.03414}}, {'zip': '59701', 'city': 'Butte', 'state': 'Montana', 'country': 'United States', 'facility': 'Butte', 'geoPoint': {'lat': 46.00382, 'lon': -112.53474}}, {'zip': '08244', 'city': 'Somers Point', 'state': 'New Jersey', 'country': 'United States', 'facility': 'New Jersey', 'geoPoint': {'lat': 39.31762, 'lon': -74.5946}}, {'city': 'Liberec', 'country': 'Czechia', 'facility': 'Liberec', 'geoPoint': {'lat': 50.76711, 'lon': 15.05619}}, {'city': 'Pardubice', 'country': 'Czechia', 'facility': 'Pardubice', 'geoPoint': {'lat': 50.04075, 'lon': 15.77659}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Praha', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Zlín', 'country': 'Czechia', 'facility': 'Zlin', 'geoPoint': {'lat': 49.22645, 'lon': 17.67065}}, {'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'Leeds', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'city': 'Liverpool', 'country': 'United Kingdom', 'facility': 'Liverpool', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Manchester', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'facility': 'Newcastle Upon Tyne', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Oxford', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'city': 'Wigan', 'country': 'United Kingdom', 'facility': 'Wigan', 'geoPoint': {'lat': 53.54296, 'lon': -2.63706}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Summit Therapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Summit Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}