Rapid Diagnostics for Upper Respiratory Infections in the Emergency Department

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Clinical Trial of Multi-respiratory Pathogen Testing Versus Usual Care in Emergency Department (ED) Patients With Upper Respiratory Symptoms

Conditions
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Common Cold, Respiratory Tract Infections, Influenza, Human

Intervention / Treatment
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* Device: Rapid respiratory pathogen nucleic acid amplification test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: University of California, Davis (UC Davis) Emergency Department patients evaluated for influenza like illness and/or upper respiratory infection by an ED physician who consent and agree to have a nasopharyngeal swab collected for the study English speaking or Spanish speaking patients Exclusion Criteria: Neonates Prisoners Employees of UC Davis/Students of the Principal Investigator or Co-Principal Investigator Non-English, non-Spanish speaking patients

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 101 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rapid respiratory pathogen test arm<br>ED patients in this arm will receive a rapid respiratory pathogen nucleic acid amplification test plus usual care. | Device: Rapid respiratory pathogen nucleic acid amplification test<br>* 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.<br>|
| No Intervention: Usual care control arm<br>ED patients in this arm will receive clinician-directed standard of care, which may include but is not limited to no testing, point-of-care influenza testing, or delayed testing for respiratory pathogens at off-site laboratory. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients Receiving Antibiotics or a Prescription for Antibiotics in the ED |  | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients With a Respiratory Pathogen Identified | Any respiratory pathogen detected by the FilmArray Respiratory Panel test or other diagnostic test ordered by the physician | Day 0 | 
| Proportion of Patients With a Laboratory-confirmed Influenza Diagnosis |  | Day 0 | 
| Proportion of Patients Receiving Appropriate Anti-influenza Treatment or Prescription | Composite rate of anti-influenza treatment in positive patients and non-use of anti-influenza treatment in negative patients | Day 0 | 
| Proportion of Patients Discharged Home From the ED Versus Hospital Admission |  | Day 0 | 
| Proportion of Patients With All-cause or Respiratory Illness-related Repeat ED Visit, Hospital or ICU Admission, or Death Within 30 Days |  | 30 days | 
| Proportion of of Patients With Clinician Adherence to Guidelines for the Treatment of Patients With Influenza (Recommendations for Use of Antivirals Only) |  | Day 0 | 
| Median Length of ED Stay |  | Day 0 | 
| Median Length of Hospital Stay |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Viral Infection, Pathology, Molecular, Respiratory Tract Infections, Influenza, Human, Common Cold, Emergency Room, Molecular Diagnostics, Diagnostic Testing, Clinical Microbiology, Polymerase Chain Reaction, Antibiotic Stewardship, Antimicrobial Use, Emergency Department