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

University of California (UC) Davis

Status: Completed

Conditions: Influenza, Human; Respiratory Tract Infections; Common Cold

Treatments: Device: Rapid respiratory pathogen nucleic acid amplification test

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02957136

894097

Details and patient eligibility

About

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).

Full 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.

Enrollment: 194 patients

Sex: All

Ages: 1 to 101 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

194 participants in 2 patient groups

Rapid respiratory pathogen test arm

Experimental group

Description:

ED patients in this arm will receive a rapid respiratory pathogen nucleic acid amplification test plus usual care.

Treatment:

Device: Rapid respiratory pathogen nucleic acid amplification test

Usual care control arm

No Intervention group

Description:

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.