Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-25 @ 3:09 PM
Study NCT ID:
NCT06616168
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-09-27
First Post:
2024-08-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Urogenital Infections in Women of Reproductive Age and the Activity of 4-Thiazolidinone Derivatives Against Pathogens
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016585', 'term': 'Vaginosis, Bacterial'}], 'ancestors': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'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': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D002443', 'term': 'Ceftriaxone'}, {'id': 'D004318', 'term': 'Doxycycline'}, {'id': 'D002981', 'term': 'Clindamycin'}, {'id': 'D009761', 'term': 'Nystatin'}, {'id': 'D000666', 'term': 'Amphotericin B'}], 'ancestors': [{'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002439', 'term': 'Cefotaxime'}, {'id': 'D002505', 'term': 'Cephacetrile'}, {'id': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D013843', 'term': 'Thiazines'}, {'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D008034', 'term': 'Lincomycin'}, {'id': 'D055231', 'term': 'Lincosamides'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D061065', 'term': 'Polyketides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-24', 'studyFirstSubmitDate': '2024-08-28', 'studyFirstSubmitQcDate': '2024-09-24', 'lastUpdatePostDateStruct': {'date': '2024-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimation of the immune activity', 'timeFrame': '1 month', 'description': 'Detection of quantities of different immune cells: lymphocytes, leukocytes, neutrophils, eosinophils'}, {'measure': 'Quantities of vaginal microflore bacteria', 'timeFrame': '2 months', 'description': 'Detection of quantities of vaginal microflore bacteria before and after antibiotic therapy (in TBC)'}], 'secondaryOutcomes': [{'measure': 'Quantities of bacteria in urine', 'timeFrame': '2 months', 'description': 'Detection of quantities of bacteria in urine (in TBC)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bacterial Vaginosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.dec.gov.ua/wp-content/uploads/2023/01/knavv2022-2264.pdf', 'label': 'Protocol of the research'}]}, 'descriptionModule': {'briefSummary': 'Research concerning women pathogenic microflora during different conditions', 'detailedDescription': 'Study of microflora of different groups of women of reproductive age, determination of pathogens and their further study, samples of a newly synthesized compound on isolated pathogens'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '49 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* urogenital infections, pregnancy\n\nExclusion Criteria:\n\n* healthy microflora'}, 'identificationModule': {'nctId': 'NCT06616168', 'briefTitle': 'Urogenital Infections in Women of Reproductive Age and the Activity of 4-Thiazolidinone Derivatives Against Pathogens', 'organization': {'class': 'OTHER', 'fullName': 'Danylo Halytsky Lviv National Medical University'}, 'officialTitle': 'Ministry of Health of Ukraine No. 2264 from 15.12.2022, Ministry of Health of Ukraine No. 310 from 08.05.2014, Ministry of Health of Ukraine No. 928 from 18.05.2023', 'orgStudyIdInfo': {'id': '15.12.23, №13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Women with bacterial vaginosis', 'description': 'Women with bacterial vaginosis (symptomatic or asymptomatic)', 'interventionNames': ['Diagnostic Test: Microbiological identification kits (ANAEROtest, STAPHYtest, ENTEROtest, NEFERMtest)', 'Drug: Antibiotic therapy after the results of antibiotic sensitivity test (Mostly Oxacillin, Benzylpenicillin, Ceftriaxone, Doxycycline, Clindamycin)', 'Combination Product: Suppositoria for vaginal microflora recovery (Giynoflor)', 'Drug: Antifungal therapy (Mostly Fluconazole, Nystatin, Amphotericin B)']}, {'type': 'EXPERIMENTAL', 'label': 'Pregnant women', 'description': 'Pregnant women with different ifections', 'interventionNames': ['Diagnostic Test: Microbiological identification kits (ANAEROtest, STAPHYtest, ENTEROtest, NEFERMtest)', 'Drug: Antibiotic therapy after the results of antibiotic sensitivity test (Mostly Oxacillin, Benzylpenicillin, Ceftriaxone, Doxycycline, Clindamycin)', 'Combination Product: Suppositoria for vaginal microflora recovery (Giynoflor)', 'Drug: Antifungal therapy (Mostly Fluconazole, Nystatin, Amphotericin B)']}, {'type': 'EXPERIMENTAL', 'label': 'Women with asymptomic infections', 'description': 'Women with asymptomic infections of urogenital tract', 'interventionNames': ['Diagnostic Test: Microbiological identification kits (ANAEROtest, STAPHYtest, ENTEROtest, NEFERMtest)', 'Drug: Antibiotic therapy after the results of antibiotic sensitivity test (Mostly Oxacillin, Benzylpenicillin, Ceftriaxone, Doxycycline, Clindamycin)', 'Combination Product: Suppositoria for vaginal microflora recovery (Giynoflor)']}], 'interventions': [{'name': 'Microbiological identification kits (ANAEROtest, STAPHYtest, ENTEROtest, NEFERMtest)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Microbiological identification kits (ANAEROtest, STAPHYtest, ENTEROtest, NEFERMtest) produced by Erba Lachema leads to bacteria detection via biochemical features', 'armGroupLabels': ['Pregnant women', 'Women with asymptomic infections', 'Women with bacterial vaginosis']}, {'name': 'Antibiotic therapy after the results of antibiotic sensitivity test (Mostly Oxacillin, Benzylpenicillin, Ceftriaxone, Doxycycline, Clindamycin)', 'type': 'DRUG', 'description': 'Antibiotic therapy after the results of antibiotic sensitivity test. Aminoglycosides, Carbapenems, Cephalosporins, Fluoroquinolones, Oxazolidinones are used. Mostly Oxacillin, Benzylpenicillin, Ceftriaxone, Doxycycline, Clindamycin are used for the therapy.', 'armGroupLabels': ['Pregnant women', 'Women with asymptomic infections', 'Women with bacterial vaginosis']}, {'name': 'Suppositoria for vaginal microflora recovery (Giynoflor)', 'type': 'COMBINATION_PRODUCT', 'description': 'Prescription of suppositoria for vaginal microflora recovery after antibiotic therapy. Probiotic grug includes Lactobacilli acidophillis as the main compound.', 'armGroupLabels': ['Pregnant women', 'Women with asymptomic infections', 'Women with bacterial vaginosis']}, {'name': 'Antifungal therapy (Mostly Fluconazole, Nystatin, Amphotericin B)', 'type': 'DRUG', 'description': 'Prescription of antifungal drugs. Triazoles (Fluconazole, Itraconazole, Voriconazole), Imidazoles (Ketoconazole), Nystatin and Amphotericin B are used the most', 'armGroupLabels': ['Pregnant women', 'Women with bacterial vaginosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '79000', 'city': 'Lviv', 'country': 'Ukraine', 'facility': 'Danylo Halytsky Lviv National Medical University', 'geoPoint': {'lat': 49.83826, 'lon': 24.02324}}], 'overallOfficials': [{'name': 'Yulian Konechnyi', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Danylo Halytsky Lviv National Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danylo Halytsky Lviv National Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}