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CompletedNCT00300534Updated Sep 7, 2012

Multi-site Study of Rapid Diagnostic Syphilis Assays

An interventional study of Abbott Laboratories Determine test for syphilis and Investigational syphilis immunochromatographic strip test in Syphilis, sponsored by Centers for Disease Control and Prevention. Completed at 5 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-09-07.

Sponsored by Centers for Disease Control and Prevention · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
1,000
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Syphilis

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Keywords

  • Diagnosis
03

In context

Syphilis

120 studies on the registry are indexed under Syphilis; 33 are open to participants now.

This study's enrollment of 1,000 is above the median of 377 across 82 interventional studies indexed under Syphilis.

Browse Syphilis studies →

Lead sponsor

Centers for Disease Control and Prevention is the lead sponsor of 273 studies on the registry; 2 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Consecutive patients

Exclusion criteria

Exclusion Criteria:

  • Less than age 18 years
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1,000 participants (actual)

Study arms

  • 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

Interventions

  • DeviceAbbott Laboratories Determine test for syphilis
  • DeviceInvestigational syphilis immunochromatographic strip test
06

What researchers measure

Primary outcomes

  1. Diagnosis of Treponema pallidum infection

    Time frame: 7 days

07

Study locations

5 sites
  • Los Angeles Department of Health Services
    Los Angeles, California, United States
  • Fulton County Department of Health
    Atlanta, Georgia, United States
  • Chicago Department of Public Health
    Chicago, Illinois 60616, United States
  • Bell Flower Clinic
    Indianapolis, Indiana 46202, United States
  • New York City Department of Health
    New York City, New York, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 7, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00300534
Lead sponsor
Centers for Disease Control and Prevention
Responsible party
Sponsor
First posted
Mar 9, 2006
Start date
Aug 2002
Primary completion
Dec 2005
Completion
Jul 2009
Last update
Sep 7, 2012

Study contacts

Robert E. Johnson, MD, MPH
principal investigator · Centers for Disease Control and Prevention
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.

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