Clinical trial NCT02957136: Rapid Diagnostics for Upper Respiratory Infections in the Emergency Department
Official title: Randomized Clinical Trial of Multi-respiratory Pathogen Testing Versus Usual Care in Emergency Department (ED) Patients With Upper Respiratory Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Tract Infections
Influenza, Human
Common Cold
Keywords: Respiratory Tract Infections
Influenza, Human
Common Cold
Viral Infection
Pathology, Molecular
Molecular Diagnostics
Diagnostic Testing
Clinical Microbiology
Polymerase Chain Reaction
Antibiotic Stewardship
Antimicrobial Use
Emergency Department
Emergency Room
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: BioFire Diagnostics, LLC
First posted: 2016-11-06
Enrollment: 194
Sex: ALL
Minimum age (years): 1
Maximum age (years): 101
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of Patients Receiving Antibiotics or a Prescription for Antibiotics in the ED
timeFrame: Day 0
Secondary outcomes:
measure: Proportion of Patients With a Respiratory Pathogen Identified
timeFrame: Day 0
measure: Proportion of Patients With a Laboratory-confirmed Influenza Diagnosis
timeFrame: Day 0
measure: Proportion of Patients Receiving Appropriate Anti-influenza Treatment or Prescription
timeFrame: Day 0
measure: Proportion of Patients Discharged Home From the ED Versus Hospital Admission
timeFrame: Day 0
measure: Proportion of Patients With All-cause or Respiratory Illness-related Repeat ED Visit, Hospital or ICU Admission, or Death Within 30 Days
timeFrame: 30 days
measure: Proportion of of Patients With Clinician Adherence to Guidelines for the Treatment of Patients With Influenza (Recommendations for Use of Antivirals Only)
timeFrame: Day 0
measure: Median Length of ED Stay
timeFrame: Day 0
measure: Median Length of Hospital Stay
timeFrame: 30 days
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
Study officials:
affiliation: Duke University
name: Christopher Polage, MD, MAS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Davis
name: Larissa May, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.