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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how quick tests for colds and similar illnesses can help doctors improve patient treatment. It uses the BIOFIRE® SPOTFIRE® Respiratory Panel, a device that identifies various viruses and bacteria causing these infections. Individuals with cold-like symptoms, such as a runny nose or cough, might be suitable participants. By testing a small nasal sample, doctors can quickly determine the cause of the illness and select the best treatment. The trial also gathers feedback from patients and doctors to assess the effectiveness of these tests in reducing unnecessary antibiotic use. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance diagnostic methods for everyone.

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 prior data suggests that the BIOFIRE® SPOTFIRE® Respiratory (R) Panel testing device is safe for diagnosing upper respiratory infections?

Research has shown that the BIOFIRE® SPOTFIRE® Respiratory Panel is safe for use. The FDA has approved this testing device, which meets strict safety and quality standards. In studies, researchers tested the device on samples from the upper respiratory system and found no safety issues. The test involves taking a small swab from the nose, a procedure similar to other common medical nose swabs. No reports have indicated any problems related to using this testing device. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the BIOFIRE® SPOTFIRE® Respiratory Panel because it offers rapid, point-of-care testing for upper respiratory infections. Unlike traditional methods that require sending samples to a lab and waiting days for results, this panel can deliver a diagnosis quickly, allowing for faster treatment decisions. This speed in testing can significantly reduce the inappropriate use of antibiotics and improve patient outcomes by ensuring the right treatment is given at the right time. By integrating this rapid testing into primary care settings, clinicians can more effectively manage respiratory infections and potentially reduce the spread of these illnesses.

What evidence suggests that the BIOFIRE® SPOTFIRE® Respiratory Panel is effective for diagnosing upper respiratory infections?

Research has shown that the BIOFIRE® SPOTFIRE® Respiratory Panel, which participants in this trial may use, effectively identifies viruses and bacteria causing upper respiratory infections (URIs). Studies have found that this test can detect up to 15 different germs, delivering results in about 15 minutes. In tests with 151 samples, the panel reliably identified these germs. This fast and thorough method helps doctors make better treatment decisions, potentially reducing unnecessary antibiotic use. Overall, the panel is a promising tool for better managing URIs by identifying the exact cause of symptoms. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

researchgate.net

researchgate.net/publication/379848842_Clinical_Evaluation_of_the_BIOFIRE_SPOTFIRE_Respiratory_Panel

Clinical Evaluation of the BIOFIRE SPOTFIRE Respiratory ...

We evaluated the performance of the SPOTFIRE R Panel with 151 specimens, including 133 collected from the upper respiratory tract (URT), 13 from ...

2.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/reviews/K232954.pdf

A 510(k) Number K232954 B Applicant BioF

The BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel is a multiplexed nucleic acid- amplification-based test that is intended to detect and identify ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38675941/

Clinical Evaluation of the BIOFIRE SPOTFIRE Respiratory ...

We evaluated the performance of the SPOTFIRE R Panel with 151 specimens, including 133 collected from the upper respiratory tract (URT), 13 ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11055108/

Clinical Evaluation of the BIOFIRE SPOTFIRE Respiratory ...

The BIOFIRE SPOTFIRE Respiratory (R) Panel is a novel, in vitro diagnostic PCR assay with 15 pathogen targets. The runtime is about 15 min.

5.

biomerieux.com

biomerieux.com/us/en/our-offer/clinical-products/biofire-spotfire-system.html

The BIOFIRE® SPOTFIRE® Respiratory/Sore Throat Panels

Simple. 1-2 minutes of hands-on time ; Fast. Turnaround time of ~15 minutes ; Comprehensive. Identify up to 15 pathogens associated with upper respiratory tract ...

6.

biofiredefense.com

biofiredefense.com/product-support/safety-data-sheets/

Safety Data Sheets

Safety Data Sheets ; BIOFIRE® SPOTFIRE® Panels ; Kit Part Nos. Description, SDS ; 423485 424537. BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Kit BIOFIRE ...

7.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/reviews/K213954.pdf

A 510(k) Number K213954 B Applicant BIOF

The BIOFIRE SPOTFIRE Respiratory (R) Panel detects and identifies nucleic acids from the following pathogens: Adenovirus, seasonal Coronavirus (229E, HKU1, ...

8.

mdpi.com

mdpi.com/1999-4915/16/4/600

Clinical Evaluation of the BIOFIRE SPOTFIRE Respiratory ...

We evaluated the performance of the SPOTFIRE R Panel with 151 specimens, including 133 collected from the upper respiratory tract (URT), 13 from ...

9.

biomerieux.com

biomerieux.com/us/en/our-offer/clinical-products/biofire-spotfire-respiratory-panels.html

BIOFIRE® SPOTFIRE® Respiratory Panels - bioMerieux

Safety Data Sheet · Product Quality and Safety · Quality Certificates · IVDR ... Identify 5 or 15 pathogens associated with upper respiratory tract infections ...