Rapid Diagnostics for Upper Respiratory Infections in the Emergency Department
Status: | Completed |
---|---|
Conditions: | Influenza, Infectious Disease, Infectious Disease, Hospital, Pulmonary |
Therapuetic Areas: | Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases, Other |
Healthy: | No |
Age Range: | 1 - 101 |
Updated: | 5/5/2018 |
Start Date: | December 8, 2016 |
End Date: | April 30, 2018 |
Randomized Clinical Trial of Multi-respiratory Pathogen Testing Versus Usual Care in Emergency Department (ED) Patients With Upper Respiratory Symptoms
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.
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.
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
We found this trial at
1
site
Sacramento, California 95814
Principal Investigator: Christopher Polage, MD, MAS
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