Rapid Diagnostics for Upper Respiratory Infections in the Emergency Department

Respiratory Tract Infections Clinical Trial

— URIDxED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02957136
• Other study ID #: 894097
• Status: Completed
• Phase: N/A
• Start date: December 8, 2016
• Est. completion date: April 30, 2018

Study information

• Verified date: April 2021
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: April 30, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 101 Years

Eligibility

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

Related Conditions & MeSH terms

• Common Cold
• Communicable Diseases
• Emergencies
• Infection
• Influenza, Human
• Respiratory Tract Infections

Intervention

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.

Locations

Country	Name	City	State
United States	UC Davis Medical Center	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	BioFire Diagnostics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Patients Receiving Antibiotics or a Prescription for Antibiotics in the ED		Day 0
Secondary	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
Secondary	Proportion of Patients With a Laboratory-confirmed Influenza Diagnosis		Day 0
Secondary	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
Secondary	Proportion of Patients Discharged Home From the ED Versus Hospital Admission		Day 0
Secondary	Proportion of Patients With All-cause or Respiratory Illness-related Repeat ED Visit, Hospital or ICU Admission, or Death Within 30 Days		30 days
Secondary	Proportion of of Patients With Clinician Adherence to Guidelines for the Treatment of Patients With Influenza (Recommendations for Use of Antivirals Only)		Day 0
Secondary	Median Length of ED Stay		Day 0
Secondary	Median Length of Hospital Stay		30 days