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Completed

NCT Number: NCT02957136

Rapid Diagnostics for Upper Respiratory Infections in the Emergency Department

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).

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Key information

Age range

1 year–101 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC Davis Medical Center

Sacramento, California, 95817, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rapid respiratory pathogen nucleic acid amplification test

Device

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.

Primary outcomes

  1. Proportion of Patients Receiving Antibiotics or a Prescription for Antibiotics in the ED

    Time frame: Day 0

Secondary outcomes

  1. Proportion of Patients With a Respiratory Pathogen Identified

    Time frame: Day 0

    Any respiratory pathogen detected by the FilmArray Respiratory Panel test or other diagnostic test ordered by the physician

  2. Proportion of Patients With a Laboratory-confirmed Influenza Diagnosis

    Time frame: Day 0

  3. Proportion of Patients Receiving Appropriate Anti-influenza Treatment or Prescription

    Time frame: Day 0

    Composite rate of anti-influenza treatment in positive patients and non-use of anti-influenza treatment in negative patients

  4. Proportion of Patients Discharged Home From the ED Versus Hospital Admission

    Time frame: Day 0

  5. Proportion of Patients With All-cause or Respiratory Illness-related Repeat ED Visit, Hospital or ICU Admission, or Death Within 30 Days

    Time frame: 30 days

  6. Proportion of of Patients With Clinician Adherence to Guidelines for the Treatment of Patients With Influenza (Recommendations for Use of Antivirals Only)

    Time frame: Day 0

  7. Median Length of ED Stay

    Time frame: Day 0

  8. Median Length of Hospital Stay

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • BioFire Diagnostics, LLC

Registry information

Official study title

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

Acronym: URIDxED

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 7, 2016
Registry last updated
May 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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