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Rapid Test for Syphilis

N/A
Recruiting
Research Sponsored by MedMira Laboratories Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients attending the Clinic for follow-up appointments following diagnosis with syphilis infection
Must not have
Patients below the age of 16 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 patient visit of appoximately 30 minutes
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test a rapid syphilis test called MedMira Inc. Multiplo® Complete Syphilis (TP/nTP) Antibody Test in Ottawa, Canada. The test will

Who is the study for?
This trial is for individuals visiting the Sexual Health Clinic in Ottawa who may be at risk of syphilis. There are no specific inclusion or exclusion criteria provided, suggesting it might be open to a broad range of participants typically seen at such clinics.
What is being tested?
The study is evaluating the MedMira Inc. Multiplo® Complete Syphilis (TP/nTP) Antibody Test, a rapid point-of-care test designed to diagnose infectious syphilis quickly and on-site, comparing its accuracy with conventional lab-based testing methods.
What are the potential side effects?
Since this trial involves a diagnostic medical device rather than medication or treatment intervention, there are no direct side effects associated with its use as it's likely similar to standard blood testing procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am following up at the clinic after being diagnosed with syphilis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am under 16 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 patient visit of appoximately 30 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 patient visit of appoximately 30 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To determine the accuracy of Multiplo Complete Syphilis (TP/nTP) Antibody Test

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Multiplo Complete Syphilis (TP/nTP) Antibody TestExperimental Treatment1 Intervention
Participants are tested with investigational devices and conventional syphilis serology tests
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Medical Device
2017
Completed Phase 4
~110

Find a Location

Who is running the clinical trial?

MedMira Laboratories Inc.Lead Sponsor
4 Previous Clinical Trials
3,249 Total Patients Enrolled
2 Trials studying Syphilis
1,600 Patients Enrolled for Syphilis
~400 spots leftby Aug 2025
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