Multi-site Study of Rapid Diagnostic Syphilis Assays

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00300534
First received: March 2, 2006
Last updated: September 6, 2012
Last verified: September 2012
  Purpose

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 Intervention
Syphilis
Device: Abbott Laboratories Determine test for syphilis
Device: Investigational syphilis immunochromatographic strip test

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • Diagnosis of Treponema pallidum infection [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Enrollment: 1000
Study Start Date: August 2002
Study Completion Date: July 2009
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Consecutive patients

Exclusion Criteria:

  • Less than age 18 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00300534

Locations
United States, California
Los Angeles Department of Health Services
Los Angeles, California, United States
United States, Georgia
Fulton County Department of Health
Atlanta, Georgia, United States
United States, Illinois
Chicago Department of Public Health
Chicago, Illinois, United States, 60616
United States, Indiana
Bell Flower Clinic
Indianapolis, Indiana, United States, 46202
United States, New York
New York City Department of Health
New York City, New York, United States
Sponsors and Collaborators
Investigators
Principal Investigator: Robert E. Johnson, MD, MPH Centers for Disease Control and Prevention
  More Information

No publications provided

Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT00300534     History of Changes
Other Study ID Numbers: CDC-NCHSTP-2875
Study First Received: March 2, 2006
Last Updated: September 6, 2012
Health Authority: United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
Diagnosis

Additional relevant MeSH terms:
Syphilis
Bacterial Infections
Genital Diseases, Female
Genital Diseases, Male
Gram-Negative Bacterial Infections
Infection
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Bacterial
Spirochaetales Infections
Treponemal Infections

ClinicalTrials.gov processed this record on October 30, 2014