Point-of-Care Testing for Epidemics

(PROMPT-LTC Trial)

Recruiting at 1 trial location

Overseen By Christopher Kandel, MD, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Michael Garron Hospital

Disqualifiers: No agreement, Existing point-of-care

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 7 months

24 Participants Needed

Trial Summary

What is the purpose of this 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, COVID-19 and Respiratory Syncytial Virus) can impact the number and size of respiratory virus outbreaks in long-term care homes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Point-of-care respiratory test platform?

Research shows that rapid molecular point-of-care testing for respiratory viruses can quickly and accurately detect infections, similar to traditional lab tests, but in a much shorter time. This can help improve the use of treatments for viruses like influenza and reduce unnecessary antibiotic use. ^{1 2 3 4 5}

Is point-of-care testing generally safe for humans?

Point-of-care testing (POCT) is widely used in healthcare settings and is considered safe for humans. It is designed to provide quick results, which can help in making timely medical decisions, but it requires careful implementation to avoid errors from samples, operators, or the testing system. ^{1 3 5 6 7}

How is the Point-of-care respiratory test platform different from other treatments for respiratory conditions?

The Point-of-care respiratory test platform is unique because it provides rapid results at the site of patient care, allowing for quicker decision-making compared to traditional lab tests that take longer. This rapid testing can improve the detection of respiratory viruses, enhance the use of antivirals, and reduce unnecessary antibiotic use, making it particularly useful during public health emergencies. ^{1 2 3 6 8}

Eligibility Criteria

This trial is for long-term care facilities in Ontario that are part of a health team overseen by Sunnybrook Health Science Centre, Michael Garron Hospital, or Humber River Health. Facilities must not already be using a point-of-care testing platform and need to sign an agreement to participate.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Implementation of point-of-care testing for rapid diagnosis of respiratory viruses in long-term care homes

7 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

60 days

Treatment Details

Interventions

• Point-of-care respiratory test platform

Trial Overview The study is comparing the effectiveness of existing respiratory virus tests with a new point-of-care test platform in providing rapid results for Influenza, COVID-19, and RSV. The goal is to see if quicker diagnostics can reduce the number and size of outbreaks in long-term care homes.

Participant Groups

Group I: Point-of-Care Polymerase Chain Reaction Testing Platform Experimental Treatment 1 Intervention

Group II: Existing Testing Platform for Respiratory Viruses Active Control 1 Intervention

Point-of-care respiratory test platform is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Point-of-care respiratory test platform for:

• Detection of Influenza
• Detection of COVID-19
• Detection of Respiratory Syncytial Virus

Approved in Canada as POC molecular testing platform for:

• Detection of Influenza
• Detection of COVID-19
• Detection of Respiratory Syncytial Virus

Approved in European Union as Rapid respiratory test platform for:

• Detection of Influenza
• Detection of COVID-19
• Detection of Respiratory Syncytial Virus

Who Is Running the Clinical Trial?

Michael Garron Hospital

Lead Sponsor

Trials

16

Recruited

7,200+

Sunnybrook Health Sciences Centre

Collaborator

Trials

693

Recruited

1,569,000+

Humber River Health

Collaborator

Trials

1

Recruited

20+

Findings from Research

The ResPOC study is a randomized controlled trial involving adults with acute respiratory illness, aiming to evaluate the effectiveness of rapid molecular point-of-care testing for respiratory viruses using the FilmArray Respiratory Panel, which provides results in 1 hour compared to traditional PCR tests that take at least 24 hours.

This trial seeks to demonstrate that molecular point-of-care testing can reduce unnecessary antibiotic use, improve the detection of respiratory viruses, and enhance the use of antiviral treatments, ultimately aiming to improve patient care in hospital settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Molecular point-of-care testing for respiratory viruses versus routine clinical care in adults with acute respiratory illness presenting to secondary care: a pragmatic randomised controlled trial protocol (ResPOC). Brendish, NJ., Malachira, AK., Clark, TW.[2022]

Point-of-care (POC) testing for infectious diseases is becoming more advanced, allowing for quicker and more effective diagnosis closer to the patient.

While these tests have improved significantly in performance, their increased complexity necessitates oversight by trained laboratory personnel to ensure accurate results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Point-of-Care Testing in Microbiology. Samuel, L.[2021]

The QuickVue rapid influenza diagnostic test demonstrated high specificity (100%) in detecting influenza, making it a reliable tool for ruling in the disease during public health emergencies.

However, its low sensitivity (23%) indicates that negative results should be confirmed with a more accurate RT-PCR test, highlighting the need for follow-up testing in cases of suspected influenza.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of rapid influenza diagnostic tests (QuickVue) for influenza A and B Infection in India. Koul, PA., Mir, H., Bhat, MA., et al.[2018]

In a study involving 720 adults with acute respiratory illness, routine point-of-care testing (POCT) for respiratory viruses did not significantly reduce the overall use of antibiotics compared to standard care, as many patients were already started on antibiotics before test results were available.

However, the POCT group had a shorter hospital stay and a higher rate of appropriate antiviral treatment for influenza, indicating that while it didn't lower antibiotic use, it improved clinical management and safety outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Routine molecular point-of-care testing for respiratory viruses in adults presenting to hospital with acute respiratory illness (ResPOC): a pragmatic, open-label, randomised controlled trial. Brendish, NJ., Malachira, AK., Armstrong, L., et al.[2022]

The implementation of a point-of-care testing (POCT) platform significantly increased lactate testing compliance from 61% to 91%, which is linked to improved adherence to sepsis protocols and potentially lower mortality rates.

The POCT platform not only reduced the average cost per test ($6.21 compared to $10.02 for the benchtop system) but also saved the hospital approximately $88,476 annually in labor costs, while enhancing efficiency and employee engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of point-of-care blood gas testing at a large community hospital: Cost analysis, sepsis bundle compliance, and employee engagement. Chase, RA., DeJuilio, PA., Huml, JP., et al.[2022]

Point-of-care testing (POCT) can significantly enhance the identification of antimicrobial resistance (AMR) in patients, particularly those critically ill with COVID-19, by enabling faster decision-making and targeted treatment options.

Implementing POCT can help reduce the risks of coinfections, improve healthcare cost-effectiveness, and potentially prevent millions of deaths due to AMR, highlighting the urgent need for healthcare professionals to adopt rapid diagnostic testing practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Geospatial Spread of Antimicrobial Resistance, Bacterial and Fungal Threats to Coronavirus Infectious Disease 2019 (COVID-19) Survival, and Point-of-Care Solutions. Kost, GJ.[2021]

Implementing point-of-care (POC) molecular COVID-19 tests requires careful planning and monitoring of operators to minimize errors from various sources, including samples and reagents.

Establishing clear policies for the preanalytic, analytic, and postanalytic phases of testing is essential for ensuring the accuracy and reliability of test results, as highlighted by guidelines from the CLSI EP23-Ed2 document.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing Individualized quality control plans and managing risk at the point-of-care for molecular diagnostics. Laryea, ET., Nichols, JH.[2023]

Point-of-care testing (POCT) is crucial for quickly detecting and managing outbreaks of infectious diseases like COVID-19, as it provides fast results that can help control the spread and improve emergency responses.

The study emphasizes that governments should support POCT initiatives and that healthcare professionals need to adopt geospatial strategies to enhance community resilience and optimize resource deployment during health crises.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Geospatial Hotspots Need Point-of-Care Strategies to Stop Highly Infectious Outbreaks. Kost, GJ.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Molecular point-of-care testing for respiratory viruses versus routine clinical care in adults with acute respiratory illness presenting to secondary care: a pragmatic randomised controlled trial protocol (ResPOC). [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Point-of-Care Testing in Microbiology. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Performance of rapid influenza diagnostic tests (QuickVue) for influenza A and B Infection in India. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Routine molecular point-of-care testing for respiratory viruses in adults presenting to hospital with acute respiratory illness (ResPOC): a pragmatic, open-label, randomised controlled trial. [2022]

5. Canada pubmed.ncbi.nlm.nih.gov

Implementation of point-of-care blood gas testing at a large community hospital: Cost analysis, sepsis bundle compliance, and employee engagement. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Geospatial Spread of Antimicrobial Resistance, Bacterial and Fungal Threats to Coronavirus Infectious Disease 2019 (COVID-19) Survival, and Point-of-Care Solutions. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Implementing Individualized quality control plans and managing risk at the point-of-care for molecular diagnostics. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Geospatial Hotspots Need Point-of-Care Strategies to Stop Highly Infectious Outbreaks. [2020]