Nctid:
NCT06616168
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000016585", "term"=>"Vaginosis, Bacterial"}], "ancestors"=>[{"id"=>"D000014623", "term"=>"Vaginal Diseases"}, {"id"=>"D000005831", "term"=>"Genital Diseases, Female"}, {"id"=>"D000052776", "term"=>"Female Urogenital Diseases"}, {"id"=>"D000005261", "term"=>"Female Urogenital Diseases and Pregnancy Complications"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D000091662", "term"=>"Genital Diseases"}, {"id"=>"D000001424", "term"=>"Bacterial Infections"}, {"id"=>"D000001423", "term"=>"Bacterial Infections and Mycoses"}, {"id"=>"D000007239", "term"=>"Infections"}, {"id"=>"D000014627", "term"=>"Vaginitis"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M18971", "name"=>"Vaginosis, Bacterial", "asFound"=>"Bacterial Vaginosis", "relevance"=>"HIGH"}, {"id"=>"M17371", "name"=>"Vaginal Diseases", "relevance"=>"LOW"}, {"id"=>"M2876", "name"=>"Genital Diseases", "relevance"=>"LOW"}, {"id"=>"M8943", "name"=>"Genital Diseases, Female", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M27093", "name"=>"Female Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M14127", "name"=>"Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M8399", "name"=>"Female Urogenital Diseases and Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M4722", "name"=>"Bacterial Infections", "relevance"=>"LOW"}, {"id"=>"M12136", "name"=>"Mycoses", "relevance"=>"LOW"}, {"id"=>"M4721", "name"=>"Bacterial Infections and Mycoses", "relevance"=>"LOW"}, {"id"=>"M17375", "name"=>"Vaginitis", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000000900", "term"=>"Anti-Bacterial Agents"}, {"id"=>"D000004318", "term"=>"Doxycycline"}, {"id"=>"D000002981", "term"=>"Clindamycin"}, {"id"=>"D000002443", "term"=>"Ceftriaxone"}, {"id"=>"D000000666", "term"=>"Amphotericin B"}, {"id"=>"D000009761", "term"=>"Nystatin"}, {"id"=>"D000010068", "term"=>"Oxacillin"}, {"id"=>"D000010400", "term"=>"Penicillin G"}, {"id"=>"D000010401", "term"=>"Penicillin G Benzathine"}, {"id"=>"D000010402", "term"=>"Penicillin G Procaine"}, {"id"=>"D000000904", "term"=>"Antibiotics, Antitubercular"}, {"id"=>"D000015725", "term"=>"Fluconazole"}, {"id"=>"C000068538", "term"=>"Liposomal amphotericin B"}, {"id"=>"D000003022", "term"=>"Clotrimazole"}, {"id"=>"D000008825", "term"=>"Miconazole"}, {"id"=>"D000000935", "term"=>"Antifungal Agents"}], "ancestors"=>[{"id"=>"D000000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D000000995", "term"=>"Antitubercular Agents"}, {"id"=>"D000000962", "term"=>"Antimalarials"}, {"id"=>"D000000981", "term"=>"Antiprotozoal Agents"}, {"id"=>"D000000977", "term"=>"Antiparasitic Agents"}, {"id"=>"D000011500", "term"=>"Protein Synthesis Inhibitors"}, {"id"=>"D000004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000058888", "term"=>"14-alpha Demethylase Inhibitors"}, {"id"=>"D000065607", "term"=>"Cytochrome P-450 Enzyme Inhibitors"}, {"id"=>"D000065088", "term"=>"Steroid Synthesis Inhibitors"}, {"id"=>"D000006727", "term"=>"Hormone Antagonists"}, {"id"=>"D000006730", "term"=>"Hormones, Hormone Substitutes, and Hormone Antagonists"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000065688", "term"=>"Cytochrome P-450 CYP2C9 Inhibitors"}, {"id"=>"D000065689", "term"=>"Cytochrome P-450 CYP2C19 Inhibitors"}, {"id"=>"D000097911", "term"=>"Third Generation Cephalosporins"}, {"id"=>"D000097902", "term"=>"Beta Lactam Antibiotics"}, {"id"=>"D000000563", "term"=>"Amebicides"}, {"id"=>"D000000891", "term"=>"Anti-Infective Agents, Local"}, {"id"=>"D000065692", "term"=>"Cytochrome P-450 CYP3A Inhibitors"}, {"id"=>"D000007476", "term"=>"Ionophores"}, {"id"=>"D000049990", "term"=>"Membrane Transport Modulators"}], "browseLeaves"=>[{"id"=>"M4222", "name"=>"Anti-Bacterial Agents", "asFound"=>"Well", "relevance"=>"HIGH"}, {"id"=>"M4224", "name"=>"Antibiotics, Antitubercular", "asFound"=>"Well", "relevance"=>"HIGH"}, {"id"=>"M20133", "name"=>"Itraconazole", "relevance"=>"LOW"}, {"id"=>"M7493", "name"=>"Doxycycline", "asFound"=>"Report", "relevance"=>"HIGH"}, {"id"=>"M6214", "name"=>"Clindamycin", "asFound"=>"Saliva", "relevance"=>"HIGH"}, {"id"=>"M5693", "name"=>"Ceftriaxone", "asFound"=>"Over 60", "relevance"=>"HIGH"}, {"id"=>"M4002", "name"=>"Amphotericin B", "asFound"=>"Validated", "relevance"=>"HIGH"}, {"id"=>"M12697", "name"=>"Nystatin", "asFound"=>"Schema", "relevance"=>"HIGH"}, {"id"=>"M12990", "name"=>"Oxacillin", "asFound"=>"Mandibular Molars", "relevance"=>"HIGH"}, {"id"=>"M13311", "name"=>"Penicillin G", "asFound"=>"Chagas Disease", "relevance"=>"HIGH"}, {"id"=>"M13312", "name"=>"Penicillin G Benzathine", "asFound"=>"Chagas Disease", "relevance"=>"HIGH"}, {"id"=>"M13313", "name"=>"Penicillin G Procaine", "asFound"=>"Chagas Disease", "relevance"=>"HIGH"}, {"id"=>"M18296", "name"=>"Fluconazole", "asFound"=>"Clinical Evaluation", "relevance"=>"HIGH"}, {"id"=>"M255436", "name"=>"Liposomal amphotericin B", "asFound"=>"Validated", "relevance"=>"HIGH"}, {"id"=>"M6252", "name"=>"Clotrimazole", "asFound"=>"Calcineurin", "relevance"=>"HIGH"}, {"id"=>"M11796", "name"=>"Miconazole", "asFound"=>"Calcineurin", "relevance"=>"HIGH"}, {"id"=>"M4254", "name"=>"Antifungal Agents", "asFound"=>"Calcineurin", "relevance"=>"HIGH"}, {"id"=>"M23006", "name"=>"Fluoroquinolones", "relevance"=>"LOW"}, {"id"=>"M22872", "name"=>"Oxazolidinones", "relevance"=>"LOW"}, {"id"=>"M256158", "name"=>"Hydroxyitraconazole", "relevance"=>"LOW"}, {"id"=>"M30607", "name"=>"Voriconazole", "relevance"=>"LOW"}, {"id"=>"M10679", "name"=>"Ketoconazole", "relevance"=>"LOW"}, {"id"=>"M5760", "name"=>"Cephalosporins", "relevance"=>"LOW"}, {"id"=>"M121171", "name"=>"Imidazole", "relevance"=>"LOW"}, {"id"=>"M220697", "name"=>"Clindamycin palmitate", "relevance"=>"LOW"}, {"id"=>"M231711", "name"=>"Clindamycin phosphate", "relevance"=>"LOW"}, {"id"=>"M13317", "name"=>"Penicillins", "relevance"=>"LOW"}, {"id"=>"M14216", "name"=>"Procaine", "relevance"=>"LOW"}, {"id"=>"M4311", "name"=>"Antitubercular Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M4280", "name"=>"Antimalarials", "relevance"=>"LOW"}, {"id"=>"M4298", "name"=>"Antiprotozoal Agents", "relevance"=>"LOW"}, {"id"=>"M4294", "name"=>"Antiparasitic Agents", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M30537", "name"=>"Cytochrome P-450 Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M9789", "name"=>"Hormones", "relevance"=>"LOW"}, {"id"=>"M9788", "name"=>"Hormone Antagonists", "relevance"=>"LOW"}, {"id"=>"M3453", "name"=>"Third Generation Cephalosporins", "relevance"=>"LOW"}, {"id"=>"M10789", "name"=>"Lactams", "relevance"=>"LOW"}, {"id"=>"M25772", "name"=>"beta-Lactams", "relevance"=>"LOW"}, {"id"=>"M3444", "name"=>"Beta Lactam Antibiotics", "relevance"=>"LOW"}, {"id"=>"M3904", "name"=>"Amebicides", "relevance"=>"LOW"}, {"id"=>"M4215", "name"=>"Anti-Infective Agents, Local", "relevance"=>"LOW"}, {"id"=>"M30564", "name"=>"Cytochrome P-450 CYP3A Inhibitors", "relevance"=>"LOW"}, {"id"=>"M10509", "name"=>"Ionophores", "relevance"=>"LOW"}, {"id"=>"T355", "name"=>"Acidophilus", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"Other Dietary Supplements", "abbrev"=>"Ot"}]}}, "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, โ13"}}, "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"}}}}
