Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-02-20 @ 8:08 PM
Study NCT ID:
NCT03167957
Status:
WITHDRAWN
Last Update Posted:
2019-03-08
First Post:
2017-05-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Oral Encochleated Amphotericin B (CAMB) in the Treatment of Fluconazole-Resistant Vulvovaginal Candidiasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014848', 'term': 'Vulvovaginitis'}, {'id': 'D002181', 'term': 'Candidiasis, Vulvovaginal'}], 'ancestors': [{'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'}, {'id': 'D002177', 'term': 'Candidiasis'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No longer target indication', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-06', 'studyFirstSubmitDate': '2017-05-23', 'studyFirstSubmitQcDate': '2017-05-24', 'lastUpdatePostDateStruct': {'date': '2019-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of subjects with clinical cure at the Test of Cure visit', 'timeFrame': '28 days', 'description': 'Resolution of the VVC signs and symptoms that were present at baseline without further antifungal treatment'}, {'measure': 'The proportion of subjects with mycological eradication at the Test of Cure visit', 'timeFrame': '28 days', 'description': 'Negative culture for growth of baseline Candida'}], 'secondaryOutcomes': [{'measure': 'Incidence of treatment emergent adverse events', 'timeFrame': '28 days', 'description': 'Safety assessments include laboratory assessments, vital signs and physical exam'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fluconazole', 'fluconazole-resistant'], 'conditions': ['Vulvovaginal Candidiases', 'Yeast Infection', 'Vulvovaginitis', 'Yeast Infection Vaginal', 'Candidiasis, Vulvovaginal']}, 'descriptionModule': {'briefSummary': 'This is a single-center, open-label, pilot study to evaluate the efficacy of 14 days of CAMB dosing in subjects with fluconazole-resistant vulvovaginal candidiasis (VVC).', 'detailedDescription': 'This is a single-center, open-label, pilot study to evaluate the efficacy of 14 days of CAMB dosing in subjects with fluconazole-resistant vulvovaginal candidiasis (VVC).\n\nApproximately 16 women with fluconazole-resistant VVC will be randomized to either 200 mg or 400 mg oral CAMB for 14 days. The primary objectives of this study are to assess the clinical cure rate, mycology eradication and responder outcome. The secondary objective of this study is to evaluate the safety of 200 mg and 400 mg doses of oral CAMB.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female 18-65 years\n* Informed Consent\n* Clinical diagnosis of fluconazole-resistant VVC\n* Negative pregnancy test\n* Vaginal pH ≤ 4.5\n\nExclusion Criteria:\n\n* Intolerance or hypersensitivity to any amphotericin B (AMB) product or to azole antifungal drugs\n* Receiving antifungal therapy unrelated to VVC or has evidence of systemic fungal infections requiring antifungal therapy\n* Received antifungal treatment for VVC within past 10 days except fluconazole, subjects must discontinue fluconazole after informed consent\n* Has another cause or suspected cause of vulvovaginitis\n* Has active HPV\n* Has other urogenital infection\n* Has other vaginal or vulvar condition that would confound interpretation of clinical response\n* Has significant laboratory abnormality at screening\n* Has Type I diabetes, use of insulin, HbA1c\\>10\n* Exposure to any investigational product within 30 days of screening\n* Has other condition that would interfere with subject ability to provide informed consent or put subject at undue risk'}, 'identificationModule': {'nctId': 'NCT03167957', 'briefTitle': 'Efficacy and Safety of Oral Encochleated Amphotericin B (CAMB) in the Treatment of Fluconazole-Resistant Vulvovaginal Candidiasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Matinas BioPharma Nanotechnologies, Inc.'}, 'officialTitle': 'A Single-Center, Open-Label, Pilot Study to Evaluate the Efficacy and Safety of Oral Encochleated Amphotericin B (CAMB) in the Treatment of Fluconazole-Resistant Vulvovaginal Candidiasis', 'orgStudyIdInfo': {'id': 'MB-70008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CAMB 200 mg', 'description': '200 mg CAMB Oral Amphotericin B', 'interventionNames': ['Drug: Oral Encochleated Amphotericin B (CAMB)']}, {'type': 'EXPERIMENTAL', 'label': 'CAMB 400 mg', 'description': '400 mg CAMB Oral Amphotericin B', 'interventionNames': ['Drug: Oral Encochleated Amphotericin B (CAMB)']}], 'interventions': [{'name': 'Oral Encochleated Amphotericin B (CAMB)', 'type': 'DRUG', 'otherNames': ['MAT2203'], 'description': 'Lipid-crystal nano-particle formulation amphotericin B', 'armGroupLabels': ['CAMB 200 mg']}, {'name': 'Oral Encochleated Amphotericin B (CAMB)', 'type': 'DRUG', 'otherNames': ['MAT2203'], 'description': 'Lipid-crystal nano-particle formulation amphotericin B', 'armGroupLabels': ['CAMB 400 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Tolan Park Clinic', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Matinas BioPharma Nanotechnologies, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}