BioFire® Respiratory Panel 2.1-EZ for Upper Respiratory Tract Infection

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
GW Immediate & Primary Care - Rhode Island Ave, Washington, United States
Upper Respiratory Tract Infection+6 More
BioFire® Respiratory Panel 2.1-EZ - DiagnosticTest
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

Rapid diagnosis and precise treatment have become possible with multiplex polymerase chain reaction (PCR) panels that can identify a variety of causative agents of acute respiratory illnesses such as bacterial and viral infections in one urgent care visit. While real-time PCR is currently used as a standard for diagnosing acute respiratory illnesses such as influenza due to its high sensitivity and specificity, it typically takes several hours for results which is unfavorable in the urgent care setting. Highly sensitive and rapid random-access PCR tests provide the sensitivity and specificity needed to both rapidly and accurately diagnose acute respiratory illnesses. Similar PCR panels have been used in previous research for the diagnosis of gastrointestinal illnesses in the emergency department and point-of-care testing for hospitalized adults presenting with acute respiratory illness. In this study, we aim to determine if a rapid multiplex PCR test for urgent care patients with symptomatic upper respiratory infections can improve patient and provider-reported outcomes. This study utilizes the Biofire® FilmArray Panel (RP2.1-EZ) which in previous studies has been shown to be highly effective in diagnosing acute respiratory illnesses.

Eligible Conditions

  • Upper Respiratory Tract Infection
  • Respiratory Tract Infections
  • Virus Diseases

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Upper Respiratory Tract Infection

Study Objectives

0 Primary · 7 Secondary · Reporting Duration: Day 7 after enrollment

Day 7
Time isolated or Recommended to Isolate
Time isolated or Recommended to Isolate by family members / close contacts
Understanding of current disease process
Day 7 after enrollment
Missed time at work or school
Need for additional diagnostic tests by participants family members / close contacts
Need for additional diagnostic tests by patient
Satisfaction with Urgent Care

Trial Safety

Safety Progress

1 of 3

Other trials for Upper Respiratory Tract Infection

Trial Design

2 Treatment Groups

Standard of Care
1 of 2
Experimental
1 of 2
Active Control
Experimental Treatment

360 Total Participants · 2 Treatment Groups

Primary Treatment: BioFire® Respiratory Panel 2.1-EZ · No Placebo Group · N/A

Experimental
DiagnosticTest
Experimental Group · 1 Intervention: BioFire® Respiratory Panel 2.1-EZ · Intervention Types: DiagnosticTest
Standard of CareNoIntervention Group · 1 Intervention: Standard of Care · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 7 after enrollment
Closest Location: GW Immediate & Primary Care - Rhode Island Ave · Washington, United States
Photo of washington 1Photo of washington 2Photo of washington 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Upper Respiratory Tract Infection
0 CompletedClinical Trials

Who is running the clinical trial?

Andrew MeltzerLead Sponsor
3 Previous Clinical Trials
788 Total Patients Enrolled
BioMérieuxIndustry Sponsor
46 Previous Clinical Trials
32,473 Total Patients Enrolled
Andrew Meltzer, MDPrincipal InvestigatorClinical Research Director, Department of Emergency Medicine
1 Previous Clinical Trials
100 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You must present with one symptom of respiratory illness.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References