OutbreaksPROMPT-LTCNCT06660433
Respiratory Outbreak Mitigation in Long-Term Care Using Point-of-Care Testing
A study testing Point-of-care respiratory test platform and Existing respiratory virus testing platform in people with Outbreaks, run by Michael Garron Hospital at 2 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Outbreaks
- What is being tested?
- Point-of-care respiratory test platform and Existing respiratory virus testing platform
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesCanada
- Study dates
- 11 Nov 2024to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Long-term care facility engaged with an Ontario Health Team overseen by Sunnybrook Health Science Centre, Michael Garron Hospital or Humber River Health
Who cannot join
- No signed statement of agreement for study participation
- Pre-existing use of a point-of-care testing platform
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Michael Garron Hospital
Toronto, Ontario, M4C 3E7
Christopher Kandel, MD, PhD, 416-469-6252, christopher.kandel@tehn.ca
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Jerome Leis, MD, MSc, 416-480-4243, jerome.leis@sunnybrook.ca
About this study
Official title: imProving Respiratory Outbreak Mitigation Through Point-of-care Testing in Long Term Care (PROMPT-LTC): A Cluster Randomized Trial
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.
- Conditions
- Outbreaks
- Being tested
- Point-of-care respiratory test platform, Existing respiratory virus testing platform
- Keywords
- respiratory virus outbreaks, outbreak mitigation, long-term care home
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Existing respiratory virus testing platformOther
Currently used respiratory virus testing platforms
| Study group | Role | What they receive |
|---|---|---|
| Point-of-Care Polymerase Chain Reaction Testing Platform | Experimental | Not described Receives: Device: Point-of-care respiratory test platform |
| Existing Testing Platform for Respiratory Viruses | Active comparator | Not described Receives: Other: Existing respiratory virus testing platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 months
Secondary outcomes (6)
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
Measured: 7 months
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
Measured: 28 days
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
Measured: 14 days
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
Measured: 28 days
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
Measured: 60 days
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
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start11 Nov 2024
- Primary completion30 May 2025
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OutbreaksStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster Randomized Trial
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michael Garron Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre, Humber River Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06660433
- Sponsor's protocol ID
- CK-19-2024
- Acronym
- PROMPT-LTC
- Status last verified
- Sep 2025
- First submitted
- 24 Oct 2024
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 38659123Kandel 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:e262644. doi: 10.1001/jamainternmed.2026.2644. Online ahead of print.
PubMed 42406366
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- imProving Respiratory Outbreak Mitigation Through Point-of-care Testing in Long Term Care (PROMPT-LTC): A Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT06660433
- Acronym / sponsor ID
- PROMPT-LTC / CK-19-2024
- Conditions
- Outbreaks
- Keywords
- respiratory virus outbreaks, outbreak mitigation, long-term care home
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Michael Garron HospitalUniversity, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre, Humber River Health
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 28 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster Randomized Trial
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Long-term care facility engaged with an Ontario Health Team overseen by Sunnybrook Health Science Centre, Michael Garron Hospital or Humber River Health
Key exclusion criteria (2 listed)
- No signed statement of agreement for study participation
- Pre-existing use of a point-of-care testing platform
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point-of-care respiratory test platformA point-of-care respiratory multiplex testing platform situated within a long-term care facility to provide rapid test results | Device | Point-of-Care Polymerase Chain Reaction Testing Platform |
| Existing respiratory virus testing platformCurrently used respiratory virus testing platforms | Other | Existing Testing Platform for Respiratory Viruses |
Primary outcome
Number of long-term care residents infected with COVID-19, Influenza, or respiratory syncytial virus (RSV)
Time frame: 7 months
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Background: PubMed 38659123Tan 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.
- Derived from this study: PubMed 42406366Kandel 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:e262644. doi: 10.1001/jamainternmed.2026.2644. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Point-of-care respiratory test platform and Existing respiratory virus testing platform in people with Outbreaks, run by Michael Garron Hospital at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher Kandel, MD, PhD (416-469-6252, christopher.kandel@tehn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of long-term care residents infected with COVID-19, Influenza, or respiratory syncytial virus (RSV) (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06660433, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.