NCT06660433

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 28, 2024

Completed
14 days until next milestone

Study Start

First participant enrolled

November 11, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

December 2, 2025

Status Verified

September 1, 2025

Enrollment Period

7 months

First QC Date

October 24, 2024

Last Update Submit

November 24, 2025

Conditions

Outbreaks

Keywords

respiratory virus outbreaksoutbreak mitigationlong-term care home

Outcome Measures

Primary Outcomes (1)

  • Number of long-term care residents infected with COVID-19, Influenza, or respiratory syncytial virus (RSV)

    The number of long-term care residents who contract Influenza, COVID-19 or RSV separated into the number of residents infected after an introduction is identified and the size of an outbreak of each virus.

    7 months

Secondary Outcomes (6)

  • The number of outbreaks of Influenza, COVID-19 or RSV

    7 months

  • The number of long-term care residents infected during an outbreak of Influenza, COVID-19 or RSV

    28 days

  • Frequency of hospital transfers for long-term care residents infected with Influenza, COVID-19 or RSV

    14 days

  • Number of deaths in long-term care residents infected with Influenza, COVID-19 or RSV

    28 days

  • Duration of outbreaks in of Influenza, COVID-19 or RSV in long-term care facilities

    60 days

  • +1 more secondary outcomes

Study Arms (2)

Point-of-Care Polymerase Chain Reaction Testing Platform

EXPERIMENTAL
Device: Point-of-care respiratory test platform

Existing Testing Platform for Respiratory Viruses

ACTIVE COMPARATOR
Other: Existing respiratory virus testing platform

Interventions

Point-of-care respiratory test platformDEVICE

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

Point-of-Care Polymerase Chain Reaction Testing Platform
Existing respiratory virus testing platformOTHER

Currently used respiratory virus testing platforms

Existing Testing Platform for Respiratory Viruses

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Michael Garron Hospital

Toronto, Ontario, M4C 3E7, Canada

RECRUITING

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

Related Publications (1)

  • 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.

    PMID: 38659123BACKGROUND

Central Study Contacts

Christopher Kandel, MD, PhD

CONTACT

416-469-6252christopher.kandel@tehn.ca

Jerome Leis, MD, MSc

CONTACT

416-480-4243jerome.leis@sunnybrook.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Cluster Randomized Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2024

First Posted

October 28, 2024

Study Start

November 11, 2024

Primary Completion

May 30, 2025

Study Completion

March 31, 2026

Last Updated

December 2, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)