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Investigational Study to Evaluate the DPP® Syphilis Screen & Confirm Antibody Point-of-care Test (POCT) to Diagnose Infectious Syphilis

StatusCompleted
PhaseNot specified
Started
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Record History

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  1. Minor Trial completed Show 4 more changesShow less
    • Final enrollment: 312 participants (planned 600)
    • Study completion date changed from estimate of Dec 31, 2026 to Sep 28, 2026
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: details revised at 1 of 2 entries
  2. Minor Re-verified, no change to tracked fieldsv3
  3. Minor Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this observational study is to evaluate the sensitivity, specificity, and utility of the DPP® Syphilis Screen \& Confirm antibody point-of-care test (POCT) to diagnose infectious syphilis in participants attending the Nine Circles Community Health Centre in Winnipeg, Manitoba. The main questions are: Does the POCT provide accurate results compared to conventional syphilis serology methods? and Can the use of POCT improve the timeline for diagnosis and treatment of syphilis? Researchers will compare the POCT results with conventional laboratory testing to assess if the rapid test can reliably diagnose syphilis during the initial clinic visit. Participants will: Provide a blood sample via fingerstick for POCT testing and complete a feedback survey to evaluate the POCT experience. Key details: This study will involve approximately 600 participants aged 18 and older over the course of 12 months which includes both new and repeat visits
Trial Details
NCT Number NCT06927843
Lead Sponsor University of Manitoba
Collaborators: Public Health Agency of Canada (PHAC), Chembio Diagnostic Systems, Inc.
Conditions
(from sponsor)
Syphilis
Related terms Syphilis
Enrollment 312 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov