CClinicalTrials.gg
RecruitingNCT06660433PROMPT-LTCUpdated Dec 2, 2025

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

An interventional study of Point-of-care respiratory test platform and Existing respiratory virus testing platform in Outbreaks, sponsored by Michael Garron Hospital. Recruiting at 2 sites in Canada. Per ClinicalTrials.gov, last updated 2025-12-02.

Sponsored by Michael Garron Hospital · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Started Nov 2024; still recruiting 1 year 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Outbreaks

Keywords

  • respiratory virus outbreaks
  • outbreak mitigation
  • long-term care home
03

In context

Lead sponsor

Michael Garron Hospital is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • No signed statement of agreement for study participation
  • Pre-existing use of a point-of-care testing platform
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    Point-of-Care Polymerase Chain Reaction Testing Platform

    Device: Point-of-care respiratory test platform

  • Active comparator
    Existing Testing Platform for Respiratory Viruses

    Other: Existing respiratory virus testing platform

Interventions

  • DevicePoint-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

  • OtherExisting respiratory virus testing platform

    Currently used respiratory virus testing platforms

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What researchers measure

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.

    Time frame: 7 months

Secondary outcomes

  1. The number of outbreaks of Influenza, COVID-19 or RSV

    The number of Influenza, COVID-19 or RSV outbreaks as declared by the local Public Health Unit

    Time frame: 7 months

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

    The number of long-term care residents with a confirmed or suspected Influenza, COVID-19 or RSV infection during each outbreak as tracked by the local Public Health Unit

    Time frame: 28 days

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

    The number of hospital transfers for long-term care residents with Influenza, COVID-19 or RSV

    Time frame: 14 days

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

    The number of long-term care residents who die following an infection with Influenza, COVID-19 or RSV

    Time frame: 28 days

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

    The total duration of an outbreak of Influenza, COVID-19 or RSV as declared by the local Public Health Unit

    Time frame: 60 days

  6. Secondary attack rate of high-risk exposures to each long-term care resident with Influenza, COVID-19 or RSV infection

    The proportion of identified high risk contacts of an infected long-term care resident with Influenza, COVID-19 or RSV infection

    Time frame: 28 days

07

Study locations

2 of 2 sites recruiting
  • Michael Garron Hospital
    Toronto, Ontario M4C 3E7, Canada
    Recruiting
  • Sunnybrook Health Sciences Centre
    Toronto, Ontario M4N 3M5, Canada
    Recruiting
08

References and documents

Publications

  • 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 Sep;45(9):1085-1089. doi: 10.1017/ice.2024.72. Epub 2024 Apr 25. PubMed 38659123 ↗
  • Kandel C, Oriotis D, Candon HL, Callahan J, Chan CK, Truong A, Rookwood A, Suleiman S, Rosario C, Wong BM, Palmer SJ, Pascual B, Serapion V, Marcovici L, Feldman S, Yip PM, Kozak RA, Taylor T, Sanstrom P, Kirk K, Eplett J, Chawla R, Brown KA, Brasg I, Powis J, Leis JA. Respiratory Outbreak Mitigation With Point-of-Care Testing in Long-Term Care: A Randomized Clinical Trial. JAMA Intern Med. 2026 Jul 6. doi: 10.1001/jamainternmed.2026.2644. Online ahead of print. PubMed 42406366 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06660433
Lead sponsor
Michael Garron Hospital
Collaborators
Sunnybrook Health Sciences Centre, Humber River Health
Responsible party
Sponsor
First posted
Oct 28, 2024
Start date
Nov 11, 2024
Primary completion
May 30, 2025
Completion
Mar 31, 2026 (estimated)
Last update
Dec 2, 2025

Study contacts

Christopher Kandel, MD, PhD
Contact
christopher.kandel@tehn.ca
416-469-6252
Jerome Leis, MD, MSc
Contact
jerome.leis@sunnybrook.ca
416-480-4243

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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