Multi-site Study of Rapid Diagnostic Syphilis Assays
Sponsor
Centers for Disease Control and Prevention (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT00300534
Collaborator
(none)
1,000
5
1
83
200
2.4
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
1000 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Multi-site Study of Rapid Diagnostic Syphilis Assays of Persons Attending STD Clinics in High Syphilis Morbidity Areas
Study Start Date
:
Aug 1, 2002
Actual Primary Completion Date
:
Dec 1, 2005
Actual Study Completion Date
:
Jul 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Abbott Laboratories Determine test for syphilis Abbott Laboratories Determine rapid test for syphilis |
Device: Abbott Laboratories Determine test for syphilis
Device: Investigational syphilis immunochromatographic strip test
|
Outcome Measures
Primary Outcome Measures
- Diagnosis of Treponema pallidum infection [7 days]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- Consecutive patients
Exclusion Criteria:
- Less than age 18 years
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Los Angeles Department of Health Services | Los Angeles | California | United States | |
| 2 | Fulton County Department of Health | Atlanta | Georgia | United States | |
| 3 | Chicago Department of Public Health | Chicago | Illinois | United States | 60616 |
| 4 | Bell Flower Clinic | Indianapolis | Indiana | United States | 46202 |
| 5 | New York City Department of Health | New York City | New York | United States |
Sponsors and Collaborators
- Centers for Disease Control and Prevention
Investigators
- Principal Investigator: Robert E. Johnson, MD, MPH, Centers for Disease Control and Prevention
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00300534
Other Study ID Numbers:
- CDC-NCHSTP-2875
First Posted:
Mar 9, 2006
Last Update Posted:
Sep 7, 2012
Last Verified:
Sep 1, 2012