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Multi-site Study of Rapid Diagnostic Syphilis Assays

NCT00300534 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2012-09-07

No results posted yet for this study

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.

Conditions

  • Syphilis

Interventions

DEVICE

Abbott Laboratories Determine test for syphilis

DEVICE

Investigational syphilis immunochromatographic strip test

Sponsors & Collaborators

Principal Investigators

  • Robert E. Johnson, MD, MPH · Centers for Disease Control and Prevention

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-08-31
Primary Completion
2005-12-31
Completion
2009-07-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00300534 on ClinicalTrials.gov