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Rapid Diagnosis of Viral Acute Respiratory Infection to Decrease Unnecessary Antibiotic Utilization in the Emergency Department (RADIATE) (RADIATE)

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ClinicalTrials.gov Identifier: NCT06271655
Recruitment Status : Recruiting
First Posted : February 22, 2024
Last Update Posted : April 9, 2024
Sponsor:
Collaborator:
BioMérieux
Information provided by (Responsible Party):
Christopher Payette, George Washington University

Brief Summary:
The study titled " The Effect of Definitive Identification of Viral Etiology in Emergency Department Patients with Acute Respiratory Infection on Antibiotic Utilization (RADIATE)" aims to investigate the effectiveness of a rapid diagnostic approach in reducing unnecessary antibiotic use in the emergency department (ED) for patients presenting with acute respiratory illness (ARI) due to a virus. Using a prospective design, eligible participants are individuals who visit the ED with complaints related to acute respiratory illness. The study will employ a single-arm consecutive enrollment approach. The intervention involves the implementation of a rapid point-of-care multiplex polymerase chain reaction (PCR) test to promptly identify the viral cause of the infection. By utilizing a rapid diagnostic tool to identify viral etiology, the study aims to provide healthcare professionals in the ED with more accurate information to guide treatment decisions. Ultimately, the goal is to decrease the unnecessary use of antibiotics for ARI's due to a virus, which has several negative outcomes including promotion of antibiotic resistance, exacerbating ED length of stay and encouraging unnecessary additional diagnostic tests.

Condition or disease Intervention/treatment Phase
Acute Respiratory Infection Viral Infection Upper Respiratory Tract Infections Device: SPOTFIRE R Panel Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: [BFD-RST-23-004] Rapid Diagnosis of Viral Acute Respiratory Infection to Decrease Unnecessary Antibiotic Utilization in the Emergency Department (RADIATE)
Actual Study Start Date : March 12, 2024
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: SPOTFIRE Arm
The intervention involves the use of a rapid point-of-care multiplex PCR test to identify viral etiology in patients with acute respiratory illness. This approach aims to provide timely and accurate diagnostic information to guide treatment decisions. Specimen samples will be collected by research staff at the time of ED presentation by NPAAS. Upon collection, the sample will be promptly prepared for testing on the SPOTFIRE R Panel device. In this trial, all providers will view Spotfire results before prescribing antibiotics ; failure to so so will be a protocol violation.
Device: SPOTFIRE R Panel
The intervention involves the use of a rapid point-of-care multiplex PCR test (Spotfire) to identify etiology of patients with ARI. Specimen samples will be collected by research staff at the time of ED presentation. Upon collection, the sample will be promptly prepared for testing on the SPOTFIRE R Panel device. The device will be in the ED to facilitate testing and accelerate delivery of diagnostic results to clinicians. The time when the provider receives the results will be recorded to evaluate the incorporation of results in clinical decision making.




Primary Outcome Measures :
  1. Antibiotic Use [ Time Frame: Study Enrollment through ED Visit Discharge, up to 24 hours ]
    The primary outcome measure is the use of antibiotics for treating acute respiratory illness.


Secondary Outcome Measures :
  1. Emergency Department Length of Stay [ Time Frame: Study Enrollment through ED Visit Discharge, up to 24 hours ]
    Length of patient stay in the ED from time of arrival to discharge

  2. Utilization of Alternative Tests [ Time Frame: Study Enrollment through ED Visit Discharge, up to 24 hours ]
    Additional diagnostic tests will be measured including chest x-rays, blood laboratory study, urinalysis, antibiotics for non-respiratory infection, anti-viral agents, CT scans

  3. Patient Confidence in Diagnosis [ Time Frame: Study Enrollment through ED Visit Discharge, up to 24 hours ]
    Patient will be asked about their confidence (Not at all confident to Extremely confident) in the diagnosis the day of testing on a Likert scale

  4. Provider Confidence in Diagnosis [ Time Frame: Study Enrollment through ED Visit Discharge, up to 24 hours ]
    Providers will be asked about their confidence in the diagnosis (Not at all confident to Extremely confident) the day of testing on a Likert scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Over the age of 18
  • Clinical suspicion of an acute respiratory infection by an emergency department provider
  • Patient endorses at least ONE symptom of respiratory illness including: cough, sneezing, runny or stuffy nose, sore throat, headaches, muscle aches, trouble breathing, shortness of breath, fever
  • Patient reports symptoms lasting less than 14 days (i.e., no chronic symptoms)
  • Patient able to provide informed consent

Exclusion Criteria:

  • Patient is a prisoner or ward of state
  • Patients that will get antibiotics regardless of of the results of the test (e.g. sepsis, hypoxia, shock, lobar pneumonia, altered mental status, meningitis, pyelonephritis, appendicitis or related, high clinical severity not otherwise specified
  • Patients who have tested positive for C. diff in the last 60 days
  • Patients who are hospitalized from the emergency department
  • Patients that have an oxygen saturation lower than 95% at triage
  • Altered mental status

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): NCT06271655


Contacts
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Contact: Christopher Payette, MD 2027412952 cpayette@mfa.gwu.edu
Contact: Ryan Heidish, BS 2027412917 rheidish@mfa.gwu.edu

Locations
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United States, District of Columbia
George Washington University Hospital Recruiting
Washington, District of Columbia, United States, 20037
Contact: Ryan Heidish       rheidish@mfa.gwu.edu   
Contact: Christopher Payette, MD       cpayette@mfa.gwu.edu   
Principal Investigator: Christopher Payette, MD         
Sub-Investigator: Andrew Meltzer, MD, MS         
Sponsors and Collaborators
Christopher Payette
BioMérieux
Investigators
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Principal Investigator: Christopher Payette, MD George Washington University
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Responsible Party: Christopher Payette, Assistant Professor of Emergency Medicine, George Washington University
ClinicalTrials.gov Identifier: NCT06271655    
Other Study ID Numbers: BFD-RST-23-004
First Posted: February 22, 2024    Key Record Dates
Last Update Posted: April 9, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Christopher Payette, George Washington University:
Antibiotic Utilization
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Respiratory Tract Infections
Virus Diseases
Emergencies
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases