Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2026-03-17 @ 11:39 PM
Study NCT ID:
NCT02733432
Status:
COMPLETED
Last Update Posted:
2020-08-31
First Post:
2016-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RADIANT: CD101 vs Standard of Care in Subjects With Acute Vaginal Yeast Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002181', 'term': 'Candidiasis, Vulvovaginal'}, {'id': 'D009181', 'term': 'Mycoses'}], 'ancestors': [{'id': 'D002177', 'term': 'Candidiasis'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014848', 'term': 'Vulvovaginitis'}, {'id': 'D014627', 'term': 'Vaginitis'}, {'id': 'D014623', 'term': 'Vaginal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D014847', 'term': 'Vulvitis'}, {'id': 'D014845', 'term': 'Vulvar Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015725', 'term': 'Fluconazole'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Sponsor blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'dispFirstSubmitDate': '2018-02-28', 'completionDateStruct': {'date': '2016-12-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-21', 'studyFirstSubmitDate': '2016-03-28', 'dispFirstSubmitQcDate': '2018-02-28', 'studyFirstSubmitQcDate': '2016-04-05', 'dispFirstPostDateStruct': {'date': '2018-03-02', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects with Incidence of Treatment Emergent Adverse Events [Safety and Tolerability]', 'timeFrame': 'Day 28 - 35', 'description': 'adverse events, clinical chemistry and hematology, pelvic exams'}], 'secondaryOutcomes': [{'measure': 'Change in Vulvovaginal Scoring System', 'timeFrame': 'Day 7 (+/- 2days)', 'description': 'Change in clinical signs and subject symptoms of VVC'}, {'measure': 'Change in Vulvovaginal Scoring System', 'timeFrame': 'Day 14 (+/- 2days)', 'description': 'Change in clinical signs and subject symptoms of VVC'}, {'measure': 'Change in Vulvovaginal Scoring System', 'timeFrame': 'Day 28 - 35', 'description': 'Change in clinical signs and subject symptoms of VVC'}, {'measure': 'Mycological Culture', 'timeFrame': 'Day 7 (+/- 2days)', 'description': 'Culture negative for Candida'}, {'measure': 'Mycological Culture', 'timeFrame': 'Day 14 (+/- 2days)', 'description': 'Culture negative Candida'}, {'measure': 'Mycological Culture', 'timeFrame': 'Day 28 -35', 'description': 'Culture negative Candida'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Candidiasis, Vulvovaginal', 'Mycoses', 'Yeast Infection', 'Moniliasis, Vulvovaginal', 'Vaginitis, Monilial']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if two topical formulations of CD101 are safe and effective in the treatment of acute moderate to severe vulvovaginal candidiasis (VVC) compared to oral fluconazole.', 'detailedDescription': 'This is a Phase 2, multicenter, randomized, open-label, sponsor-blind, active-controlled, dose-ranging trial of female subjects with an acute moderate to severe episode of vulvovaginal candidiasis. Subjects will be randomized to 1 of 3 treatment arms; CD101 gel, CD101 ointment, or oral fluconazole. After randomization, subjects will be seen on Day 7 (+/-2 days), Day 14 (+/- 2 days), \\& Day 28 (+/-7 days) to assess therapeutic cure and safety.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* moderate to severe acute vulvovaginal candidiasis (severity score \\>7)\n* positive potassium hydroxide wet preparation for pseudohyphae or budding yeast or positive Becton Dickinson Affirm test or positive vaginal culture for Candida species\n* vaginal pH \\<4.5 for subjects with positive potassium hydroxide wet preparation\n* able to give written informed consent\n\nExclusion Criteria:\n\n* receipt of intravaginal or systemic antifungal therapy within 7 days of randomization\n* known or suspected infectious causes of vulvovaginitis other than candidiasis\n* history of genital herpes\n* planned treatment or surgery during the study period for cervical intraepithelial neoplasia or cervical carcinoma\n* need for non-protocol systemic or vaginal antifungal therapy\n* history of hypersensitivity or allergic reaction to echinocandins, azoles, or their excipients\n* pregnant females\n* females who are breast feeding\n* women intending to become pregnant during the study period\n* recent use of an investigational medicinal product within 28 days or presence of an investigational device at the time of screening\n* subjects who use or anticipate use of intravaginal products\n* have any condition that the Investigator believes would put the subject at risk for participation or would confound the results of the study'}, 'identificationModule': {'nctId': 'NCT02733432', 'briefTitle': 'RADIANT: CD101 vs Standard of Care in Subjects With Acute Vaginal Yeast Infections', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cidara Therapeutics Inc.'}, 'officialTitle': 'A Phase 2, Multicenter, Randomized, Active-controlled Study of the Safety and Tolerability of Two Formulations of CD101 Compared to Fluconazole for the Treatment of Moderate to Severe Episodes of Acute Vulvovaginal Candidiasis', 'orgStudyIdInfo': {'id': 'CD101.TP.2.01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'CD101 Vaginal Gel (3%) topically self-administered intravaginally as a single dose on days 1 and 2 and for symptomatic relief CD101 External Gel (1%)topically self-applied to external vulva up to twice per day over 72 hours.', 'interventionNames': ['Drug: CD101 Vaginal Gel (3%)', 'Drug: CD101 External gel (1%)']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': 'CD101 Vaginal Ointment (6%) topically self-administered intravaginally as a single dose on day 1 and for symptomatic relief CD101 External Ointment (1%) topically self-applied to external vulva up to twice per day over 72 hours.', 'interventionNames': ['Drug: CD101 Vaginal Ointment (6%)', 'Drug: CD101 External ointment (1%)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cohort 3', 'description': 'Oral fluconazole (150mg) administered on day 1.', 'interventionNames': ['Drug: Fluconazole']}], 'interventions': [{'name': 'CD101 Vaginal Gel (3%)', 'type': 'DRUG', 'description': 'CD101 Vaginal Gel (3%) intravaginally applied topical gel on Days 1 and 2', 'armGroupLabels': ['Cohort 1']}, {'name': 'CD101 External gel (1%)', 'type': 'DRUG', 'description': 'CD101 external gel (1%) applied topically twice daily over 72 hours as needed', 'armGroupLabels': ['Cohort 1']}, {'name': 'CD101 Vaginal Ointment (6%)', 'type': 'DRUG', 'description': 'CD101 vaginal ointment (6%) intravaginally applied topical ointment on Day 1', 'armGroupLabels': ['Cohort 2']}, {'name': 'CD101 External ointment (1%)', 'type': 'DRUG', 'description': 'CD101 external ointment (1%) applied topically twice daily over 72 hours as needed', 'armGroupLabels': ['Cohort 2']}, {'name': 'Fluconazole', 'type': 'DRUG', 'description': 'oral fluconazole (150mg) on Day 1', 'armGroupLabels': ['Cohort 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Precision Trials AZ LLC', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "The Women's Clinical, P.A.", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92111', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': "Women's Health Care Research Corp", 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33756', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Olympian Clinical Research', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33759', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': "Women's Medical Research", 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33461', 'city': 'Lake Worth', 'state': 'Florida', 'country': 'United States', 'facility': 'Altus Research Inc', 'geoPoint': {'lat': 26.61708, 'lon': -80.07231}}, {'zip': '33186', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'New Age Medical Research Corporation', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Augusta University', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '70006', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Clinical Trials Management LLC', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Tolan Park Clinic', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48604', 'city': 'Saginaw', 'state': 'Michigan', 'country': 'United States', 'facility': 'Saginaw Valley Medical Research Group LLC', 'geoPoint': {'lat': 43.41947, 'lon': -83.95081}}, {'zip': '08648', 'city': 'Lawrenceville', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Lawrence OB GYN Clinical Research LLC', 'geoPoint': {'lat': 40.29733, 'lon': -74.7296}}, {'zip': '08075', 'city': 'Riverside Park', 'state': 'New Jersey', 'country': 'United States', 'facility': "Alliance Women's Research Group LLC", 'geoPoint': {'lat': 40.03844, 'lon': -74.97461}}, {'zip': '11777', 'city': 'Port Jefferson', 'state': 'New York', 'country': 'United States', 'facility': 'ProHEALTH Care Associates, LLP', 'geoPoint': {'lat': 40.94649, 'lon': -73.06927}}, {'zip': '28562', 'city': 'New Bern', 'state': 'North Carolina', 'country': 'United States', 'facility': "Eastern Carolina Women's Center", 'geoPoint': {'lat': 35.10849, 'lon': -77.04411}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Hawthorne Medical Research Inc', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': "Unified Women's Clinical Research - Hickory", 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '43123', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Aventiv Research Inc', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19102', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Drexel University College of Medicine', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77054', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'TMC Life Research Inc.', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Clinical Trials of Texas Inc', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '23502', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Tidewater Clinical Research, Inc', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Women's Health, Research, Gynecology", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Alena Jandourek, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cidara Therapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cidara Therapeutics Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}