Trials / Recruiting

RecruitingNCT06586905

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.

Status: Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 1,300 (estimated)

Sponsor: MedMira Laboratories Inc. · Industry
Sex: All
Age: 16 Years
Healthy volunteers: Accepted

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).

Conditions

Interventions

Type	Name	Description
DEVICE	Medical Device	Multiplo Complete Syphilis (TP/nTP) Antibody Test

Timeline

Start date: 2024-08-26
Primary completion: 2026-01-31
Completion: 2026-07-31
First posted: 2024-09-19
Last updated: 2025-11-18

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT06586905. Inclusion in this directory is not an endorsement.