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Recruiting NCT06660433

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

No phase Interventional Outbreaks

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Point-of-care respiratory test platform, Existing respiratory virus testing platform.
Who it may be relevant to
Registry conditions: Outbreaks. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

imProving Respiratory Outbreak Mitigation Through Point-of-care Testing in Long Term Care (PROMPT-LTC): A Cluster Randomized Trial

Overview

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.

Interventions

  • Device 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
  • Other Existing respiratory virus testing platform
    Currently used respiratory virus testing platforms

Primary outcome measures

  • Number of long-term care residents infected with COVID-19, Influenza, or respiratory syncytial virus (RSV) [Time frame: 7 months]
Secondary outcome measures (6)
  • The number of outbreaks of Influenza, COVID-19 or RSV [Time frame: 7 months]
  • The number of long-term care residents infected during an outbreak of Influenza, COVID-19 or RSV [Time frame: 28 days]
  • Frequency of hospital transfers for long-term care residents infected with Influenza, COVID-19 or RSV [Time frame: 14 days]
  • Number of deaths in long-term care residents infected with Influenza, COVID-19 or RSV [Time frame: 28 days]
  • Duration of outbreaks in of Influenza, COVID-19 or RSV in long-term care facilities [Time frame: 60 days]
  • Secondary attack rate of high-risk exposures to each long-term care resident with Influenza, COVID-19 or RSV infection [Time frame: 28 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

Canada · 2 centers
  • Michael Garron Hospital — Toronto
  • Sunnybrook Health Sciences Centre — Toronto

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. PMID 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 J PMID 42406366

Identifiers

NCT: NCT06660433 · CK-19-2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗