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Multi-site Study of Rapid Diagnostic Syphilis Assays

Primary Purpose

Syphilis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Abbott Laboratories Determine test for syphilis
Investigational syphilis immunochromatographic strip test
Sponsored by
Centers for Disease Control and Prevention
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Syphilis focused on measuring Diagnosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Consecutive patients Exclusion Criteria: Less than age 18 years

Sites / Locations

  • Los Angeles Department of Health Services
  • Fulton County Department of Health
  • Chicago Department of Public Health
  • Bell Flower Clinic
  • New York City Department of Health

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

Abbott Laboratories Determine test for syphilis

Arm Description

Abbott Laboratories Determine rapid test for syphilis

Outcomes

Primary Outcome Measures

Diagnosis of Treponema pallidum infection

Secondary Outcome Measures

Full Information

First Posted
March 2, 2006
Last Updated
September 6, 2012
Sponsor
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT00300534
Brief Title
Multi-site Study of Rapid Diagnostic Syphilis Assays
Official Title
Multi-site Study of Rapid Diagnostic Syphilis Assays of Persons Attending STD Clinics in High Syphilis Morbidity Areas
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centers for Disease Control and Prevention

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Syphilis
Keywords
Diagnosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Abbott Laboratories Determine test for syphilis
Arm Type
No Intervention
Arm Description
Abbott Laboratories Determine rapid test for syphilis
Intervention Type
Device
Intervention Name(s)
Abbott Laboratories Determine test for syphilis
Intervention Type
Device
Intervention Name(s)
Investigational syphilis immunochromatographic strip test
Primary Outcome Measure Information:
Title
Diagnosis of Treponema pallidum infection
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Consecutive patients Exclusion Criteria: Less than age 18 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert E. Johnson, MD, MPH
Organizational Affiliation
Centers for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Los Angeles Department of Health Services
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Fulton County Department of Health
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Chicago Department of Public Health
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Facility Name
Bell Flower Clinic
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
New York City Department of Health
City
New York City
State/Province
New York
Country
United States

12. IPD Sharing Statement

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Multi-site Study of Rapid Diagnostic Syphilis Assays

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