Recruiting

Multiplo® Test

Sponsor:

MedMira Laboratories Inc.

Code:

NCT06586905

Conditions

Syphilis

Treponema Pallidum

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Accepted

Interventions

Medical Device

Study Details

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 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

Syphilis

Treponema Pallidum

Study ID

NCT06586905

Start date

Aug 26, 2024

Status verified date

Nov, 2025

Completion date

Jul 31, 2026

Anticipated

Primary completion date

Jan 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

1300 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Multiplo Complete Syphilis (TP/nTP) Antibody Test

Participants are tested with investigational devices and conventional syphilis serology tests

Interventions

Medical Device

Multiplo Complete Syphilis (TP/nTP) Antibody Test

Primary outcome measure

  • To determine the accuracy of Multiplo Complete Syphilis (TP/nTP) Antibody Test [ Time Frame: 1 patient visit of appoximately 30 minutes ]

Central Contacts and Locations

Central contacts

Kayla Turner

902-450-1588

Locations

Sexual Health Clinic

Recruiting

Ottawa, Ontario, Canada, K1N 1B3

Contacts

Principal Investigator:

Patrick O Byrne

More Information

Sponsor

MedMira Laboratories Inc.

Last update posted

Nov 18, 2025

Last verified

Nov, 2025

Keywords

  • Syphilis
  • TP/nTP
  • Multiplo Complete Syphilis (TP/nTP) Antibody Test
  • MedMira
  • Treponema pallidum
  • rapid test
  • point of care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by MedMira Laboratories Inc. on 2025-11-18.