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
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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
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 Treponemal Infections Gram-Negative Bacterial Infections Bacterial Infections Sexually Transmitted Diseases, Bacterial |
Spirochaetales Infections Sexually Transmitted Diseases Infection Genital Diseases, Male Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 23, 2013