Rapid Diagnostics for Upper Respiratory Infections in the Emergency Department
Condition: Respiratory Tract Infections; Influenza, Human; Common Cold
MeSH terms: Infections; Communicable Diseases; Influenza, Human; Respiratory Tract Infections; Common Cold; Emergencies
Study type: Interventional

Summary: 
      This is a randomized clinical trial to assess the effect of rapid, near point-of-care testing
      for multiple common respiratory viruses and bacteria on antibiotic and anti-influenza
      medication use in emergency department (ED) patients with symptoms of influenza-like illness
      (ILI) and/or upper respiratory infection (URI).
    

Detailed description: 
      This is a randomized clinical trial to assess the effect of rapid, near point-of-care testing
      for multiple common respiratory viruses and bacteria on antibiotic and anti-influenza
      medication use in emergency department (ED) patients with symptoms of influenza-like illness
      (ILI) and/or upper respiratory infection (URI). The intervention is a rapid,
      multi-respiratory pathogen nucleic acid amplification panel test (FilmArray Respiratory
      Panel; BioFire Diagnostics, LLC) with clinical result reporting within two hours of sample
      collection. Randomization is at the individual patient level. Intervention patients will
      receive usual care plus the rapid multi-respiratory pathogen test. Control patients will
      receive physician-directed usual care without the rapid, multi-respiratory pathogen test,
      which may include but is not limited to no testing, point-of-care influenza testing, or
      delayed testing for multiple respiratory pathogens at an off-site laboratory. The primary
      outcome is antibiotic administration or prescription during the initial ED episode of care.
      The investigators primary hypothesis is that rapid multi-respiratory pathogen testing will be
      associated with a ≥15% reduction in antibiotic use in intervention patients, relative to
      control patients (usual care). The investigators secondary outcome is administration or
      prescription of antivirals during the initial ED episode of care. The investigators secondary
      hypothesis is that rapid multi-respiratory pathogen testing will improve anti-influenza
      medication use in intervention patients (composite rate of anti-influenza treatment in
      positive patients and non-use of anti-influenza treatment in negative patients), relative to
      control patients receiving usual care alone.
    

Intervention name(s): Rapid respiratory pathogen nucleic acid amplification test
Intervention type(s): Device
Intervention description(s): Patients randomized to the rapid respiratory pathogen nucleic acid amplification test (Film Array Respiratory Panel, BioFire Diagnostics), will receive usual physician-directed care plus results from a rapid diagnostic test for 20 common respiratory pathogens. Patients will have a nasopharyngeal swab sample collected and tested during the ED episode of care with results reported in the electronic medical record (EMR) within two hours of sample collection. ED physicians will receive education regarding the rapid respiratory pathogen test prior to commencing the study. During the study, ED physicians will be free to review and interpret the respiratory pathogen test results and make treatment decisions based on their individual clinical judgment without involvement of study personnel.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Respiratory Tract Infections; Influenza, Human; Common Cold; Viral Infection; Pathology, Molecular; Molecular Diagnostics; Diagnostic Testing; Clinical Microbiology; Polymerase Chain Reaction; Antibiotic Stewardship; Antimicrobial Use; Emergency Department; Emergency Room