Multi-site Study of Rapid Diagnostic Syphilis Assays

Not Applicable

Completed

• Conditions: Syphilis
• Interventions: Device: Abbott Laboratories Determine test for syphilis; Device: Investigational syphilis immunochromatographic strip test

• Registration Number: NCT00300534
• Lead Sponsor: Centers for Disease Control and Prevention

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-08
• Primary Completion: 2005-12
• Study First Submitted: 2006-03-02
• Study First Submitted QC: 2006-03-02
• Study First Posted: 2006-03-09
• Study Completion: 2009-07
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-06
• Last Update Posted: 2012-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Consecutive patients

Exclusion Criteria

• Less than age 18 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Abbott Laboratories Determine test for syphilis	Abbott Laboratories Determine test for syphilis	Abbott Laboratories Determine rapid test for syphilis
Abbott Laboratories Determine test for syphilis	Investigational syphilis immunochromatographic strip test	Abbott Laboratories Determine rapid test for syphilis

Primary Outcome Measures

Name	Time	Method
Diagnosis of Treponema pallidum infection	7 days

Trial Locations

Locations (5)

Los Angeles Department of Health Services; 🇺🇸 Los Angeles, California, United States

Bell Flower Clinic; 🇺🇸 Indianapolis, Indiana, United States

Fulton County Department of Health; 🇺🇸 Atlanta, Georgia, United States

Chicago Department of Public Health; 🇺🇸 Chicago, Illinois, United States

New York City Department of Health; 🇺🇸 New York City, New York, United States