Rapid Diagnostics for Upper Respiratory Infections in the Emergency Department

Not Applicable

Completed

• Conditions: Respiratory Tract Infections; Common Cold; Influenza, Human
• Interventions: Device: Rapid respiratory pathogen nucleic acid amplification test

• Registration Number: NCT02957136
• Lead Sponsor: University of California, Davis

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-10-31
• Study First Submitted QC: 2016-11-04
• Study First Posted: 2016-11-06
• Study Start: 2016-12-08
• Primary Completion: 2018-04-30
• Study Completion: 2018-04-30
• Results First Submitted: 2020-12-17
• Results First Submitted QC: 2021-01-13
• Results First Posted: 2021-02-02
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 194

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

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Exclusion Criteria

• Neonates
• Prisoners
• Employees of UC Davis/Students of the Principal Investigator or Co-Principal Investigator
• Non-English, non-Spanish speaking patients

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Proportion of Patients Receiving Antibiotics or a Prescription for Antibiotics in the ED	Day 0

Secondary Outcome Measures

Name	Time	Method
Proportion of Patients With a Laboratory-confirmed Influenza Diagnosis	Day 0
Proportion of Patients With a Respiratory Pathogen Identified	Day 0	Any respiratory pathogen detected by the FilmArray Respiratory Panel test or other diagnostic test ordered by the physician
Proportion of Patients Receiving Appropriate Anti-influenza Treatment or Prescription	Day 0	Composite rate of anti-influenza treatment in positive patients and non-use of anti-influenza treatment in negative patients
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

Trial Locations

Locations (1)

UC Davis Medical Center; 🇺🇸 Sacramento, California, United States