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.

May 30, 2024 updated by: MedMira Laboratories Inc.

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. The MedMira Inc. Multiplo® Complete Syphilis (TP/nTP) Antibody Test is Authorized for Investigational Use.

This study is to test the Multiplo Complete Syphilis (TP/nTP) Antibody Test for its performance in an urban STI clinic using finger-prick obtained whole blood to perform the POCT at the clinic.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The evaluation will determine the sensitivity and specificity of the POCT results compared to results obtained by the standard conventional syphilis serology tests performed at the Public Health Ontario Laboratory. The evaluation will also include a survey on patients' acceptability of syphilis POCT, and a survey of health care providers for feasibility of its use in the clinic.

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Kayla Turner
  • Phone Number: 9024501588

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada
        • Sexual Health Clinic
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Able to provide consent
  • Patients Requiring Syphilis testing as part of care plan
  • Patients attending Clinic for follow up appointments following diagnosis with syphilis infection.
  • Patients 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 provided care
  • Minimum 16 years of age

Exclusion Criteria:

  • Unable to provide informed consent due to possible intoxication and/or with extreme distress or confused
  • Patients below the age of 16 years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Diagnostic: Multiplo Complete Syphilis (TP/nTP) Antibody Test
Subjects are tested with investigational devices and conventional syphilis serology tests.
Device: Multiplo Complete Syphilis (TP/nTP) Antibody Test
All subjects tested with both investigational devices and conventional syphilis serology tests.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine if a POCT for syphilis administered at a clinic, can provide comparable results to those obtained by conventional laboratory testing.
Time Frame: 12 months
To test this hypothesis we propose to use the MedMira Inc. Multiplo® Complete Syphilis (TP/nTP) Antibody Test (POCT) (MedMira Inc., Halifax, Nova Scotia) in parallel with the conventional laboratory testing methods as the gold standard, in the Sexual Health Clinic in Ottawa, Ontario. The sensitivity and specificity of the Multiplo® Complete Syphilis POCT shall be determined against results obtained by the gold standard.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the feasibility and utility (acceptability by patients) of this POCT in the patient population under study.
Time Frame: 12 months
The acceptability of POCT by clients will be done by asking recruited participants to take part in a survey for their opinion after POCT testing, while feasibility of using POCT in a clinic will be done by surveying the health care providers (HCPs) for their opinion at the end of the study. Responses will be tabulated to determine the most common responses among these groups.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MedMira Laboratories Inc.

Investigators

  • Principal Investigator: Patrick O'Byrne, PhD, Sexual Health Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

May 24, 2024

First Submitted That Met QC Criteria

May 30, 2024

First Posted (Actual)

May 31, 2024

Study Record Updates

Last Update Posted (Actual)

May 31, 2024

Last Update Submitted That Met QC Criteria

May 30, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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