Syph-Check Syphilis Antibody Point of Care (POC) Test - Full Text View

Sponsored by:	Healthcare Providers Direct, Inc.
Information provided by:	Healthcare Providers Direct, Inc.
ClinicalTrials.gov Identifier:	NCT00732355

Purpose

The study is designed to evaluate the performance of a rapid membrane test in a clinic or doctor's office setting to identify potential patients infected with syphilis and compare the results to currently licensed laboratory based tests.

Condition	Intervention
Syphilis Serodiagnosis	Device: Syph-Check POC

MedlinePlus related topics: Syphilis

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Observational
Study Design:	Ecologic or Community, Prospective
Official Title:	One-Step Syphilis Point of Care Test for Rapid Immunoassay Screening of Antibodies to Treponema Pallidum

Further study details as provided by Healthcare Providers Direct, Inc.:

Primary Outcome Measures:

Identify the sensitivity and specificity of the POC test versus accepted laboratory tests [ Time Frame: end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percent positive agreement data will include supplemental test results identified by infection categories and treatment as possible [ Time Frame: end of study ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	600
Study Start Date:	October 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
I known syphilis infected patients	Device: Syph-Check POC Rapid membrane test for syphilis antibodies
U presumed uninfected patients	Device: Syph-Check POC Rapid membrane test for syphilis antibodies

Detailed Description:

The overall objectives of this study are to determine the performance characteristics of a candidate rapid point-of-care test (Syph-Check cassette format) for Treponema pallidum antibodies in serum, plasma and finger stick whole blood obtained from females and males attending sexually transmitted diseases (STD) clinics, family planning / reproductive health clinics, and physician's office; and to compare the performance of this new, rapid test to currently licensed laboratory based tests, the non-treponemal RPR and a Treponemal ELISA or TPPA test.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Point of Care clinics and doctor's office that test routine patients (both male and female), i.e. STD clinics, planned parenthood, pre-marital, blood donors, pre-employment, and general populations from different geographic locations having varying prevalence populations.

Criteria

Inclusion Criteria:

Men and Women will be eligible who:
1. are 18 years of age or older;
2. Routine "presumed uninfected" for screening visit, or show symptomatic signs of infection or are asymptomatic but are suspected of infection, and either/or have other STD disease conditions and infections, will be identified.
3. Pregnant women in the first and third trimester

Exclusion Criteria:

are under 18 years of age
unwillingness to give consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00732355

Contacts

Contact: Charlotte A Gaydos, Dr.P.H

410-614-0932

cgaydos@jhmi.edu

Locations

United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205

Sponsors and Collaborators

Healthcare Providers Direct, Inc.

Investigators

Study Director:

Gary L Lehnus, Ph.D.

Lehnus & Associates Consulting

More Information

Responsible Party:	President ( Norman Proulx )
Study ID Numbers:	SY-101
Study First Received:	August 8, 2008
Last Updated:	August 11, 2008
ClinicalTrials.gov Identifier:	NCT00732355
Health Authority:	United States: Institutional Review Board

Keywords provided by Healthcare Providers Direct, Inc.:

syphilis

Study placed in the following topic categories:

Genital Diseases, Female
Bacterial Infections
Antibodies
Sexually Transmitted Diseases

Genital Diseases, Male
Syphilis
Immunoglobulins
Gram-Negative Bacterial Infections

Additional relevant MeSH terms:

Sexually Transmitted Diseases, Bacterial
Treponemal Infections
Immunologic Factors
Spirochaetales Infections

Physiological Effects of Drugs
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009