Respiratory Outbreak Mitigation in Long-Term Care Using Point-of-Care Testing

NCT ID: NCT06660433

Last Updated: 2025-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-11

Study Completion Date

2026-03-31

Brief Summary

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Outbreaks of seasonal respiratory viruses can spread rapidly in long-term care homes. Timely results for diagnostic tests remains a challenge for respiratory viruses due to the logistics of using a reference laboratory with delays leading to missed opportunities to implement virus-specific control measures to interrupt transmission resulting in larger outbreaks. Use of a point-of-care testing platform is a potential solution that provides faster results, but it is uncertain whether this translates into benefits for long-term care residents. This trial aims to assess whether rapid test results for respiratory pathogens (Influenza, Coronavirus disease of 2019 (COVID-19) and Respiratory Syncytial Virus) can impact the number and size of respiratory virus outbreaks in long-term care homes.

Detailed Description

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Conditions

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Outbreaks

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cluster Randomized Trial
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Point-of-Care Polymerase Chain Reaction Testing Platform

Group Type EXPERIMENTAL

Point-of-care respiratory test platform

Intervention Type DEVICE

A point-of-care respiratory multiplex testing platform situated within a long-term care facility to provide rapid test results

Existing Testing Platform for Respiratory Viruses

Group Type ACTIVE_COMPARATOR

Existing respiratory virus testing platform

Intervention Type OTHER

Currently used respiratory virus testing platforms

Interventions

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Point-of-care respiratory test platform

A point-of-care respiratory multiplex testing platform situated within a long-term care facility to provide rapid test results

Intervention Type DEVICE

Existing respiratory virus testing platform

Currently used respiratory virus testing platforms

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\- Long-term care facility engaged with an Ontario Health Team overseen by Sunnybrook Health Science Centre, Michael Garron Hospital or Humber River Health

Exclusion Criteria

* No signed statement of agreement for study participation
* Pre-existing use of a point-of-care testing platform
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sunnybrook Health Sciences Centre

OTHER

Sponsor Role collaborator

Humber River Health

UNKNOWN

Sponsor Role collaborator

Michael Garron Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Michael Garron Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Christopher Kandel, MD, PhD

Role: CONTACT

416-469-6252

Jerome Leis, MD, MSc

Role: CONTACT

416-480-4243

Facility Contacts

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Christopher Kandel, MD, PhD

Role: primary

416-469-6252

Jerome Leis, MD, MSc

Role: primary

416-480-4243

References

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Tan C, Chan CK, Ofner M, O'Brien J, Thomas NR, Callahan J, Pascual B, Palmer SJ, Serapion V, Fabro H, Kozak RA, Candon H, Chan AK, Powis JE, Leis JA. Implementation of point-of-care molecular testing for respiratory viruses in congregate living settings. Infect Control Hosp Epidemiol. 2024 Apr 25;45(9):1-5. doi: 10.1017/ice.2024.72. Online ahead of print.

Reference Type BACKGROUND
PMID: 38659123 (View on PubMed)

Other Identifiers

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CK-19-2024

Identifier Type: -

Identifier Source: org_study_id

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