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

NCT06271655 | Active Not Recruiting FDA Device

• 1 other identifier: BFD-RST-23-004
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Infection; Viral Infection; Upper Respiratory Tract Infections

Keywords

Antibiotic Utilization

Outcome Measures

Primary Outcomes (1)

• Antibiotic Use

  The primary outcome measure is the use of antibiotics for treating acute respiratory illness.

  Study Enrollment through ED Visit Discharge, up to 24 hours

Secondary Outcomes (4)

• Emergency Department Length of Stay

  Study Enrollment through ED Visit Discharge, up to 24 hours

• Utilization of Alternative Tests

  Study Enrollment through ED Visit Discharge, up to 24 hours

• Patient Confidence in Diagnosis

  Study Enrollment through ED Visit Discharge, up to 24 hours

• Provider Confidence in Diagnosis

  Study Enrollment through ED Visit Discharge, up to 24 hours

Study Arms (1)

SPOTFIRE Arm

EXPERIMENTAL

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

Interventions

SPOTFIRE R Panel DEVICE

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.

SPOTFIRE Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Christopher Payette: lead
• BioMérieux: collaborator

Study Sites (1)

George Washington University Hospital

Washington D.C., District of Columbia, 20037, United States

Location

MeSH Terms

Conditions

Virus Diseases; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• Christopher Payette, MD

  George Washington University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Emergency Medicine

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: February 22, 2024
• Study Start: March 12, 2024
• Primary Completion: September 20, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)