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NCT00300534 Clinical Trial

Multi-site Study of Rapid Diagnostic Syphilis Assays

Syphilis Clinical Trial

Official title:
Multi-site Study of Rapid Diagnostic Syphilis Assays of Persons Attending STD Clinics in High Syphilis Morbidity Areas

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00300534
Other study ID # CDC-NCHSTP-2875
Secondary ID
Status Completed
Phase N/A
First received March 2, 2006
Last updated September 6, 2012
Start date August 2002
Est. completion date July 2009

Study information
Verified date September 2012
Source Centers for Disease Control and Prevention
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Device:
• Abbott Laboratories Determine test for syphilis

• Investigational syphilis immunochromatographic strip test

Locations
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

Sponsors (1)
Lead Sponsor Collaborator
Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Diagnosis of Treponema pallidum infection 7 days No
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