Rapid Testing for Upper Respiratory Tract Infection

(PROTECT Trial)

Overseen By Lauren Dutcher, MD, MSCE

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Age < 18, No URI symptoms

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

Compensation: Varies

Number of Visits: Unknown

8000 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on testing for infections rather than changing your current treatment.

What data supports the effectiveness of the treatment BIOFIRE® SPOTFIRE® Respiratory (R) Panel for upper respiratory tract infections?

The BioFire FilmArray Respiratory Panel has been shown to quickly and accurately detect a wide range of respiratory pathogens, which can help doctors make better treatment decisions and improve disease management in both children and adults. ^{1 2 3 4 5}

Is the BIOFIRE® SPOTFIRE® Respiratory Panel safe for humans?

The research does not provide specific safety data for the BIOFIRE® SPOTFIRE® Respiratory Panel, but similar diagnostic tests like the Panther Fusion system have been used safely in studies for detecting respiratory viruses. ^{6 7 8 9 10}

What is the purpose of this trial?

The goal of this study is to understand the use of point of care (POC) testing devices in primary care offices to help clinicians diagnose and appropriately treat patients who have symptoms of upper respiratory infections (URIs). The study will use the BIOFIRE® SPOTFIRE® Respiratory (R) Panel testing device, which is FDA-cleared and CLIA-Waived. This panel can identify up to 15 different viruses and bacteria that can cause URIs. These POC devices will be installed in primary care clinics within the University of Pennsylvania Health System. Patients who come to the clinic with cold-like symptoms (runny nose, cough) will be offered the test. If the patient agrees to the test, their clinician will use a swab to take a small sample of fluid from their nose. This swab will then be tested within the POC device and results will be available within 15 minutes. The results of this sample will be shared with the patient, and their clinician can use the results to help decide the most appropriate medical treatment for the patient. Patients who agree to take the test will be asked to answer a short survey about the test and their experience. Clinicians will also be surveyed to share their thoughts with using the test in their clinics. Focus groups of practice staff and clinicians will also be conducted to understand any potential challenges for using this test in practice. Results from the tests and the surveys will help researchers understand the value of the test to support antibiotic stewardship efforts in primary care clinic settings.

Eligibility Criteria

This trial is for adults over 18 with symptoms of an upper respiratory infection, such as cough, runny nose, nasal congestion, fever, sore throat or ear pain. It aims to improve how primary care doctors diagnose and treat these common illnesses.

Inclusion Criteria

I am experiencing symptoms like cough, fever, and sore throat.

Exclusion Criteria

I am under 18 years old.

I don't have symptoms like a cough or trouble breathing.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of POC respiratory pathogen testing in primary care practices, including focus groups and surveys of clinicians

2 months

Intervention

Pragmatic, stepped-wedge, cluster randomized trial to study the impact of POC testing on antibiotic prescribing

Duration not specified

Follow-up

Participants are monitored for healthcare utilization and prescription patterns after the index visit

2 weeks

Treatment Details

Interventions

• BIOFIRE® SPOTFIRE® Respiratory (R) Panel

Trial Overview The study tests a rapid on-site diagnostic tool called the BIOFIRE® SPOTFIRE® Respiratory Panel in primary care settings. It quickly identifies various viruses and bacteria causing respiratory infections to guide appropriate treatment.

Participant Groups

Group I: Patients Experimental Treatment 2 Interventions

All adult patients (age \>=18 years) at one of the included primary care practices seen for an upper respiratory infection or symptom will be included in the primary study analysis, as identified by ICD-10 code (from baseline and intervention periods). Patients with ICD-10 codes for other bacterial infections at the same encounter will be excluded (e.g., skin and soft tissue infection) from the analysis. During the intervention period, adult patients with symptoms potentially suggestive of an upper respiratory infection will be eligible for use of the POC RPP test.

Group II: Clinicians/practice staff Experimental Treatment 3 Interventions

Clinicians will be the target for the intervention that will include provision of the POC RPP (Point of Care Respiratory Pathogen Panel) test as well as clinical guidance on use and interpretation. Clinicians will also be included in focus groups and surveys, and other administrative practice staff will also be included in focus groups. All clinicians/staff practicing at one of the included practices will be eligible for inclusion

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

References

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

Performance and Impact of a CLIA-waived, Point-of-care Respiratory PCR Panel in a Pediatric Clinic. [2021]

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

Real-Life Assessment of BioFire FilmArray® Pneumonia Panel in Adults Hospitalized with Respiratory Illness. [2023]

3. Canada pubmed.ncbi.nlm.nih.gov

Evaluation of a Multiplex PCR Panel for the Microbiological Diagnosis of Pneumonia in Hospitalized Patients: Experience from an Academic Medical Center. [2021]

4. New Zealand pubmed.ncbi.nlm.nih.gov

BioFire&#174; FilmArray&#174; Pneumonia Panel for Severe Lower Respiratory Tract Infections: Subgroup Analysis of a Randomized Clinical Trial. [2021]

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

FilmArray respiratory panel assay: An effective method for detecting viral and atypical bacterial pathogens in bronchoscopy specimens. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Comparison of the performance of the Panther Fusion respiratory virus panel to R-Gene and laboratory developed tests for diagnostic and hygiene screening specimens from the upper and lower respiratory tract. [2020]

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

Allergic diagnosis: skin testing and rast. [2005]

8. India pubmed.ncbi.nlm.nih.gov

Minimum Allergen Screening Panel for Allergic Rhinitis in Bangalore: A Cross Sectional Study. [2023]

9. Germany pubmed.ncbi.nlm.nih.gov

The allergen quick test: a simple allergy test to prove existing sensitization. [2019]

10. China pubmed.ncbi.nlm.nih.gov

[The value of Phadiatop and spot skin test in diagnosis of allergic rhinitis]. [2015]