Syphilis Clinical Trial
Official title:
Multi-site Study of Rapid Diagnostic Syphilis Assays of Persons Attending STD Clinics in High Syphilis Morbidity Areas
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.
Status | Completed |
Enrollment | 1000 |
Est. completion date | July 2009 |
Est. primary completion date | December 2005 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Consecutive patients Exclusion Criteria: - Less than age 18 years |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | Fulton County Department of Health | Atlanta | Georgia |
United States | Chicago Department of Public Health | Chicago | Illinois |
United States | Bell Flower Clinic | Indianapolis | Indiana |
United States | Los Angeles Department of Health Services | Los Angeles | California |
United States | New York City Department of Health | New York City | New York |
Lead Sponsor | Collaborator |
---|---|
Centers for Disease Control and Prevention |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnosis of Treponema pallidum infection | 7 days | No |
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