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.

Last updated: September 4, 2024
Sponsor: MedMira Laboratories Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hiv

Sexually Transmitted Diseases (Stds)

Gynecological Infections

Treatment

Medical Device

Clinical Study ID

NCT06586905
REB 2023-034P
  • Ages > 16
  • All Genders
  • Accepts Healthy Volunteers

Study 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 congenital syphilis cases and stillbirths, the demand of a rapid test such as POCT that can be used at the place and time that front-line public health workers meet the at risk population is getting louder. Indeed during a number of federal, provincial and territorial meetings on the control of syphilis outbreaks in Canada, requests for POCT to detect syphilis infections have repeatedly come up. However, before a POCT can be widely used, research to find out if it is accurate and reliable is necessary. This study is designed to test the performance of the MedMira Inc. Multiplo® Complete Syphilis (TP/nTP) Antibody Test (POCT) (MedMira Inc., Halifax, Nova Scotia) in an urban clinic (Sexual Health Clinic) in Ottawa, Ontario, Canada and compare its performance in parallel with the usual testing method (the gold standard, i.e. conventional syphilis serology testing).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Individuals attending the Clinic for routine sexual health care and requiringsyphilis testing as part of this care, who are able to provide informed consent andare a minimum 16 years of age are eligible for this study. This includes patientsattending the Clinic for follow-up appointments following diagnosis with syphilisinfection. Those who have had other STIs in the past, or being suspected of havingother STIs, are not excluded as long as testing for syphilis is part of the careprovided to them. Once it has been determined that the exclusion criteria does notapply to a patient, the recruitment of participants will be offered without otherpre-selection criteria unless there may be other unforeseeable circumstancesarising, such as shortage of Clinic staff or large numbers of patients inattendance.

Exclusion

Exclusion Criteria:

  • Those who, at the discretion of the HCPs/research co-ordinator, appear intoxicatedand/or with extreme distress, or confused, will be excluded from this researchbecause they would not be able to provide informed consent to participate, as wellas those below the age of 16 years.

Study Design

Total Participants: 600
Treatment Group(s): 1
Primary Treatment: Medical Device
Phase:
Study Start date:
August 26, 2024
Estimated Completion Date:
February 26, 2026

Connect with a study center

  • Sexual Health Clinic

    Ottawa, Ontario K1N 1B3
    Canada

    Active - Recruiting

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