Rapid Diagnostics for Upper Respiratory Infections in the Emergency Department (URIDxED)

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

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).

Study Overview

• Status: Completed
• Conditions: Respiratory Tract Infections; Influenza, Human; Common Cold
• Intervention / Treatment: Device: Rapid respiratory pathogen nucleic acid amplification test

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.

• Study Type: Interventional
• Enrollment (Actual): 194
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • UC Davis Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 101 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rapid respiratory pathogen test arm; 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; 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.
No Intervention: Usual care control arm; 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?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of California, Davis
• Collaborators: BioFire Diagnostics, LLC
• Investigators: Principal Investigator: Christopher Polage, MD, MAS, Duke University; Principal Investigator: Larissa May, MD, MSPH, University of California, Davis

Publications and helpful links

General Publications

• May L, Tatro G, Poltavskiy E, Mooso B, Hon S, Bang H, Polage C. Rapid Multiplex Testing for Upper Respiratory Pathogens in the Emergency Department: A Randomized Controlled Trial. Open Forum Infect Dis. 2019 Nov 5;6(12):ofz481. doi: 10.1093/ofid/ofz481. eCollection 2019 Dec.

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2016
• Primary Completion (Actual): April 30, 2018
• Study Completion (Actual): April 30, 2018

Study Registration Dates

• First Submitted: October 31, 2016
• First Submitted That Met QC Criteria: November 4, 2016
• First Posted (Estimate): November 6, 2016

Study Record Updates

• Last Update Posted (Actual): May 19, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Emergency Department; Respiratory Tract Infections; Emergency Room; Common Cold; Polymerase Chain Reaction; Influenza, Human; Viral Infection; Antibiotic Stewardship; Diagnostic Testing; Molecular Diagnostics; Pathology, Molecular; Clinical Microbiology; Antimicrobial Use
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Disease Attributes; Picornaviridae Infections; Orthomyxoviridae Infections; Emergencies; Infections; Communicable Diseases; Influenza, Human; Respiratory Tract Infections; Common Cold
• Other Study ID Numbers: 894097

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO