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NCT06586905
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.
NA trial testing Medical Device in Syphilis in 1,300 participants. Currently enrolling.
31 January 2026
Quick facts
| Lead sponsor | MedMira Laboratories Inc. |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 1,300 |
| Start date | 26 August 2024 |
| Primary completion | 31 January 2026 |
| Estimated completion | 31 July 2026 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Medical Device
Conditions studied
- Syphilis — all drugs for Syphilis →
- Treponema Pallidum — all drugs for Treponema Pallidum →
Sponsor
MedMira Laboratories Inc.
Who can join
16 and older, any sex, with Syphilis or Treponema Pallidum. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Evaluating the MedMira Multiplo® Complete Syphilis (TP/nTP) antibody test in a sexually transmitted infection clinic in Ottawa, Canada: increased rapid diagnosis and improved antibiotic stewardship.
O'Byrne P, Dillabough R, Whyte K, Orser L, et al · · 2025 · PMID 41361278 · DOI 10.1186/s12879-025-12263-w
Verify or expand the search:
- PubMed search for NCT06586905
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Syphilis
Currently open trials in the same condition.
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- NCT07300254 — Treponemal Shedding, Load, and Viability, in Women and Men-who-have-sex-with-women-only With Early Infectious Syphilis: · recruiting
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- NCT06927843 — Investigational Study to Evaluate the DPP® Syphilis Screen & Confirm Antibody Point-of-care Test (POCT) to Diagnose Infe · active not recruiting
- NCT06683638 — Daily Doxycycline for Early Syphillis · Phase 2 · recruiting
Other MedMira Laboratories Inc. trials
Trials by the same sponsor.
- NCT05831098 — Evaluation of the Sensitivity, Specificity, and Utility of the Reveal® TP (Syphilis) Antibody POCT · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06586905 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by MedMira Laboratories Inc.
- Last refreshed: 18 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06586905.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing