Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-26 @ 1:15 AM
Study NCT ID:
NCT00300534
Status:
COMPLETED
Last Update Posted:
2012-09-07
First Post:
2006-03-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multi-site Study of Rapid Diagnostic Syphilis Assays
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013587', 'term': 'Syphilis'}, {'id': 'D004194', 'term': 'Disease'}], '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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-06', 'studyFirstSubmitDate': '2006-03-02', 'studyFirstSubmitQcDate': '2006-03-02', 'lastUpdatePostDateStruct': {'date': '2012-09-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnosis of Treponema pallidum infection', 'timeFrame': '7 days'}]}, 'conditionsModule': {'keywords': ['Diagnosis'], 'conditions': ['Syphilis']}, 'descriptionModule': {'briefSummary': 'The performance of an investigational immunochromatographic strip (ICS) test for the diagnosis of syphilis is compared with the Abbott Laboratories Determine ICS test. The study population consists of patients with and without syphilis presenting to sexually transmitted disease clinics in five cities in the United States. Specimens include finger-stick whole blood (investigational test only) and whole blood, plasma, and serum by venipuncture.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consecutive patients\n\nExclusion Criteria:\n\n* Less than age 18 years'}, 'identificationModule': {'nctId': 'NCT00300534', 'briefTitle': 'Multi-site Study of Rapid Diagnostic Syphilis Assays', 'organization': {'class': 'FED', 'fullName': 'Centers for Disease Control and Prevention'}, 'officialTitle': 'Multi-site Study of Rapid Diagnostic Syphilis Assays of Persons Attending STD Clinics in High Syphilis Morbidity Areas', 'orgStudyIdInfo': {'id': 'CDC-NCHSTP-2875'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Abbott Laboratories Determine test for syphilis', 'description': 'Abbott Laboratories Determine rapid test for syphilis', 'interventionNames': ['Device: Abbott Laboratories Determine test for syphilis', 'Device: Investigational syphilis immunochromatographic strip test']}], 'interventions': [{'name': 'Abbott Laboratories Determine test for syphilis', 'type': 'DEVICE', 'armGroupLabels': ['Abbott Laboratories Determine test for syphilis']}, {'name': 'Investigational syphilis immunochromatographic strip test', 'type': 'DEVICE', 'armGroupLabels': ['Abbott Laboratories Determine test for syphilis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Los Angeles Department of Health Services', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Fulton County Department of Health', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60616', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Chicago Department of Public Health', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Bell Flower Clinic', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York City Department of Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Robert E. Johnson, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centers for Disease Control and Prevention'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}