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

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ClinicalTrials.gov Identifier: NCT02957136
Recruitment Status : Completed
First Posted : November 7, 2016
Last Update Posted : May 3, 2018
Sponsor:
Collaborator:
BioFire Diagnostics, LLC
Information provided by (Responsible Party):
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). 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.

Condition or disease Intervention/treatment Phase
Respiratory Tract Infections Influenza, Human Common Cold Device: Rapid respiratory pathogen nucleic acid amplification test Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 194 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Randomized Clinical Trial of Multi-respiratory Pathogen Testing Versus Usual Care in Emergency Department (ED) Patients With Upper Respiratory Symptoms
Actual Study Start Date : December 8, 2016
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu

Arm Intervention/treatment
Experimental: Rapid respiratory pathogen test arm
ED patients in this arm will receive a rapid respiratory pathogen nucleic acid amplification test plus usual care.
Device: Rapid respiratory pathogen nucleic acid amplification test
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.

No Intervention: Usual care control arm
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.



Primary Outcome Measures :
  1. Proportion of patients receiving antibiotics or a prescription for antibiotics in the ED [ Time Frame: Day 0 ]

Secondary Outcome Measures :
  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. Clinician adherence to guidelines for the treatment of patients with influenza (recommendations for use of antivirals only) [ Time Frame: Day 0 ]
  7. Length of ED stay [ Time Frame: Day 0 ]
  8. Length of hospital stay [ Time Frame: 30 days ]
  9. Time to influenza test results [ Time Frame: 7 days ]
  10. Time to other respiratory pathogen test results [ Time Frame: 7 days ]


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Ages Eligible for Study:   1 Year to 101 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02957136


Locations
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United States, California
UC Davis Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
BioFire Diagnostics, LLC
Investigators
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Principal Investigator: Christopher Polage, MD, MAS Duke University
Principal Investigator: Larissa May, MD, MSPH University of California, Davis

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT02957136     History of Changes
Other Study ID Numbers: 894097
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of California, Davis:
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
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Respiratory Tract Infections
Influenza, Human
Common Cold
Emergencies
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Picornaviridae Infections