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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00732355 |
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Date of registration:
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08/08/2008 |
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Primary sponsor: |
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Public title:
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Syph-Check Syphilis Antibody Point of Care (POC) Test
SyphPoc |
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Scientific title:
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One-Step Syphilis Point of Care Test for Rapid Immunoassay Screening of Antibodies to Treponema Pallidum |
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Date of first enrolment:
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October 2008 |
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Target sample size:
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600 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00732355 |
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Study type:
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Observational |
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Study design:
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Observational Model: Ecologic or Community, Time Perspective: Prospective
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Countries of recruitment
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United States
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Contacts
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Name:
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Charlotte A Gaydos, Dr.P.H. |
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Address:
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Telephone:
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410-614-0932 |
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Email:
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cgaydos@jhmi.edu |
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Affiliation:
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Name:
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Charlotte A Gaydos, Dr.P.H |
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Address:
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Telephone:
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410-614-0932 |
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Email:
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cgaydos@jhmi.edu |
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Affiliation:
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Name:
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Gary L Lehnus, Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Lehnus & Associates Consulting |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Syphilis Serodiagnosis
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Intervention(s)
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Device: Syph-Check POC
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Primary Outcome(s)
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Identify the sensitivity and specificity of the POC test versus accepted laboratory tests
[Time Frame: end of study]
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Secondary Outcome(s)
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Percent positive agreement data will include supplemental test results identified by infection categories and treatment as possible
[Time Frame: end of study]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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