Status:
RECRUITING
A Cross-sectional Investigational Study to Evaluate the Sensitivity, Specificity, and Utility of the MedMira Inc. Multiplo® Complete Syphilis (TP/nTP) Antibody Test (POCT) to Diagnose Infectious Syphilis in Participants Attending the Sexual Health Clinic in Ottawa, Ontario.
Lead Sponsor:
MedMira Laboratories Inc.
Collaborating Sponsors:
Public Health Agency of Canada (PHAC)
Conditions:
Syphilis
Treponema Pallidum
Eligibility:
All Genders
16+ years
Phase:
NA
Brief Summary
Due to the recent resurgence of infectious syphilis in Canada and the changing epidemiology of the disease to involve heterosexuals and females of child bearing age leading to a record number of conge...
Eligibility Criteria
Inclusion
- Individuals attending the Clinic for routine sexual health care and requiring syphilis testing as part of this care, who are able to provide informed consent and are a minimum 16 years of age are eligible for this study. This includes patients attending the Clinic for follow-up appointments following diagnosis with syphilis infection. Those who have had other STIs in the past, or being suspected of having other STIs, are not excluded as long as testing for syphilis is part of the care provided to them. Once it has been determined that the exclusion criteria does not apply to a patient, the recruitment of participants will be offered without other pre-selection criteria unless there may be other unforeseeable circumstances arising, such as shortage of Clinic staff or large numbers of patients in attendance.
Exclusion
- Those who, at the discretion of the HCPs/research co-ordinator, appear intoxicated and/or with extreme distress, or confused, will be excluded from this research because they would not be able to provide informed consent to participate, as well as those below the age of 16 years.
Key Trial Info
Start Date :
August 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
1300 Patients enrolled
Trial Details
Trial ID
NCT06586905
Start Date
August 26 2024
End Date
July 31 2026
Last Update
November 18 2025
Active Locations (1)
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1
Sexual Health Clinic
Ottawa, Ontario, Canada, K1N 1B3