Rapid Diagnostics for Upper Respiratory Infections in the Emergency Department

NCT02957136 | Completed Results

• 1 other identifier: 894097
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (1)

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

  Day 0

Secondary Outcomes (8)

• Proportion of Patients With a Respiratory Pathogen Identified

  Day 0

• Proportion of Patients With a Laboratory-confirmed Influenza Diagnosis

  Day 0

• Proportion of Patients Receiving Appropriate Anti-influenza Treatment or Prescription

  Day 0

• 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

Study Arms (2)

Rapid respiratory pathogen test arm

EXPERIMENTAL

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

Usual care control arm

NO INTERVENTION

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.

Interventions

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.

Rapid respiratory pathogen test arm

Eligibility Criteria

• Age: 1 Year - 101 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Davis: lead
• BioFire Diagnostics, LLC: collaborator

Study Sites (1)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

Related Publications (1)

• 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.

  PMID: 32128326 DERIVED

MeSH Terms

Conditions

Respiratory Tract Infections; Influenza, Human; Common Cold; Virus Diseases; Emergencies

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; RNA Virus Infections; Picornaviridae Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Christopher Polage
• Organization: Duke University Health System

christopher.polage@duke.edu

919-668-5008

Study Officials

• Christopher Polage, MD, MAS

  Duke University

  PRINCIPAL INVESTIGATOR

• Larissa May, MD, MSPH

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2016
• First Posted: November 7, 2016
• Study Start: December 8, 2016
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: May 19, 2021
• Results First Posted: February 2, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)