Rapid Test for Respiratory Infections

(RADIATE Trial)

Not currently recruiting at 2 trial locations

Overseen By Ryan Heidish, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Christopher Payette

Disqualifiers: Prisoner, Sepsis, C. diff, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a rapid method to identify viral causes of respiratory infections in emergency room visitors. The goal is to determine if quick testing can reduce unnecessary antibiotic use, which can lead to antibiotic resistance and longer hospital stays. Participants will have their respiratory symptoms tested using the SPOTFIRE R Panel, a rapid diagnostic test, to identify if a virus causes their illness. Suitable candidates have experienced new symptoms like a cough, sneezing, or a stuffy nose for less than two weeks. As an unphased trial, this study offers an opportunity to contribute to important research that could enhance rapid diagnosis and treatment for respiratory infections.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this rapid diagnostic approach is safe for patients with acute respiratory illness?

Research has shown that the SPOTFIRE R Panel is a safe tool for diagnosing illnesses. This rapid PCR test, meeting U.S. quality standards for lab tests, quickly and accurately detects 15 different respiratory germs. Importantly, reports indicate no serious side effects, suggesting the test is well-tolerated for identifying respiratory infections. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SPOTFIRE R Panel because it offers a rapid and precise diagnostic tool for identifying viral causes of acute respiratory illnesses. Unlike traditional methods, which often rely on broad-spectrum antibiotics or delayed lab results, this point-of-care test uses multiplex PCR technology to quickly pinpoint the viral culprit. This fast turnaround can help doctors make better treatment decisions on the spot, potentially reducing unnecessary antibiotic use and improving patient outcomes.

What evidence suggests that the SPOTFIRE R Panel is effective for reducing unnecessary antibiotic use in acute respiratory infections?

Research shows that the SPOTFIRE R Panel, used by participants in this trial, reliably detects viruses causing respiratory infections. This test identifies 15 different germs and provides results in about 15 minutes. By determining if a virus is responsible for the illness, doctors can avoid unnecessary antibiotic prescriptions, helping to prevent antibiotic misuse and resistance. Previous studies have demonstrated that this rapid test delivers accurate and comprehensive results, aiding healthcare providers in making better treatment decisions. ^{1 6 7 8 9}

Who Is on the Research Team?

Christopher Payette, MD

Principal Investigator

George Washington University

Are You a Good Fit for This Trial?

The RADIATE trial is for adults over 18 who visit the emergency department with symptoms of an acute respiratory illness lasting less than two weeks. They must be able to consent and have at least one symptom like cough, sneezing, or fever. There's no mention of exclusion criteria.

Inclusion Criteria

A doctor thinks I might have a serious lung infection.

Patient able to provide informed consent

I am over 18 years old.

Exclusion Criteria

Patients who have tested positive for C. diff in the last 60 days

Patient is a prisoner or ward of state

Patients who are hospitalized from the emergency department

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Enrollment and Testing

Eligible participants undergo a rapid point-of-care multiplex PCR test to identify viral etiology

1 day

1 visit (in-person)

Follow-up

Participants are monitored for antibiotic use and additional diagnostic tests during their ED visit

Up to 24 hours

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• SPOTFIRE R Panel

Trial Overview This study tests a rapid PCR test called SPOTFIRE R Panel in the emergency department to quickly identify viral infections causing respiratory illness, aiming to reduce unnecessary antibiotic use by providing accurate diagnosis.

How Is the Trial Designed?

Group I: SPOTFIRE Arm Experimental Treatment 1 Intervention

The intervention involves the use of a rapid point-of-care multiplex PCR test to identify viral etiology in patients with acute respiratory illness. This approach aims to provide timely and accurate diagnostic information to guide treatment decisions. Specimen samples will be collected by research staff at the time of ED presentation by NPAAS. Upon collection, the sample will be promptly prepared for testing on the SPOTFIRE R Panel device. In this trial, all providers will view Spotfire results before prescribing antibiotics ; failure to so so will be a protocol violation.

Who Is Running the Clinical Trial?

Christopher Payette

Lead Sponsor

Trials

1

Recruited

200+

BioMérieux

Industry Sponsor

Trials

62

Recruited

43,500+

Pierre Boulud

BioMérieux

Chief Executive Officer since 2023

Degree in Biology from Lyon I University, Graduate of HEC Montreal Business School

Dr. Charles K. Cooper

BioMérieux

Chief Medical Officer since 2024

MD from Georgetown University School of Medicine, Specialized in Infectious Diseases and Epidemiology at University of Maryland, Baltimore

Citations

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

Clinical Evaluation of the BIOFIRE SPOTFIRE Respiratory ... Considering the raw data, there were 30 discrepant results between the SPOTFIRE R Panel and RP2.1plus, with 24 'false positives' and 6 ...

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

BIOFIRE® SPOTFIRE® Respiratory Panels - bioMerieux The SPOTFIRE R Panel is a CLIA-waived multiplex PCR test that detects 15 pathogens to provide accurate and comprehensive diagnostic results during a patient ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/acem.70156

Point‐Of‐Care Respiratory Diagnosis and Antibiotic ... Participants underwent rapid multiplex PCR testing (BIOFIRE SPOTFIRE Respiratory Panel), with results provided to clinicians in real time.

4. biofiredx.com biofiredx.com/blog/biofire-spotfire-targeted-vs-expanded-panel/

BIOFIRE® SPOTFIRE® Respiratory Solution: A Custom Fit ... The BIOFIRE SPOTFIRE Respiratory Solution offers onsite, lab-grade PCR respiratory testing with results on a syndromic panel in about 15 minutes.

5. biofiredx.com biofiredx.com/products/solutions/point-of-care/

Point-of-Care Infectious Disease Testing The SPOTFIRE R Panel tests for the 15 most probable viruses and bacteria that cause respiratory tract infections, with results in about 15 minutes, enabling ...

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

The BIOFIRE® SPOTFIRE® Respiratory/Sore Throat Panels Rapid PCR testing for respiratory and sore throat infections has the potential to benefit not only the patients you care for, but also to enhance your clinic's ...

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

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.

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/K232954.pdf

March 26, 2024 BioFire Diagnostics, LLC Kevin Bourzac VP ... The SPOTFIRE R/ST Panel simultaneously identifies 15 different respiratory viral and bacterial pathogens in nasopharyngeal swabs (NPS) or 14 ...

9. biofiredefense.com biofiredefense.com/products/biofire-spotfire/

The BIOFIRE ® SPOTFIRE ® System The SPOTFIRE R/ST Panel Mini tests for the 5 most probable viruses or bacteria that cause respiratory and sore throat symptoms, including influenza, rhinovirus, ...