Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2026-04-22 @ 9:07 PM
Study NCT ID:
NCT02871505
Status:
UNKNOWN
Last Update Posted:
2018-11-16
First Post:
2016-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Association Between Molecular Typing of Treponema Pallidum and Treatment Efficacy and Clinical Findings
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013587', 'term': 'Syphilis'}], 'ancestors': [{'id': 'D014211', 'term': 'Treponemal Infections'}, {'id': 'D013145', 'term': 'Spirochaetales Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015231', 'term': 'Sexually Transmitted Diseases, Bacterial'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010400', 'term': 'Penicillin G'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-15', 'studyFirstSubmitDate': '2016-08-09', 'studyFirstSubmitQcDate': '2016-08-15', 'lastUpdatePostDateStruct': {'date': '2018-11-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'rapid plasma regain titer', 'timeFrame': '6 months after treatment'}]}, 'conditionsModule': {'conditions': ['Syphilis']}, 'descriptionModule': {'briefSummary': 'The investigators compare the treatment results and clicical presentations of different Molecular subtyping of Treponema pallidum'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n1\\. Persons with confirmed early symptomatic syphilis (primary or secondary) or high-titer latent syphilis\n\nExclusion Criteria:\n\n1. Pregnant woman\n2. Known allergy to penicillin\n3. RPR titers were found to be 1:8 or less'}, 'identificationModule': {'nctId': 'NCT02871505', 'briefTitle': 'The Association Between Molecular Typing of Treponema Pallidum and Treatment Efficacy and Clinical Findings', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'orgStudyIdInfo': {'id': 'PUMCH-2016079'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Molecular subtyping (14d/f) of Treponema pallidum', 'description': 'Benzathine Penicillin G treatment', 'interventionNames': ['Drug: Benzathine Penicillin G']}, {'type': 'EXPERIMENTAL', 'label': 'Molecular subtyping (others) of Treponema pallidum', 'description': 'Benzathine Penicillin G treatment', 'interventionNames': ['Drug: Benzathine Penicillin G']}], 'interventions': [{'name': 'Benzathine Penicillin G', 'type': 'DRUG', 'armGroupLabels': ['Molecular subtyping (14d/f) of Treponema pallidum', 'Molecular subtyping (others) of Treponema pallidum']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jun Li, M.D.', 'role': 'CONTACT', 'email': 'lijun35@hotmail.com', 'phone': '86-010-69151504'}], 'facility': 'Department of Dermatology and Venereology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jun Li, M.D.', 'role': 'CONTACT', 'email': 'lijun35@hotmail.com', 'phone': '86-010-69151504'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jun Li', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}