Urgent Care Management of Respiratory Illness Enabled With Novel Testing Pathway

NCT05467007 | Completed Results FDA Device

• 1 other identifier: NCR213901
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 2

Brief 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, the investigators 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.

Conditions

Viral Infection; Acute Respiratory Infection; Upper Resp Tract Infection

Outcome Measures

Primary Outcomes (1)

• Satisfaction With Time to Receive Result

  Based on any results you have received from today's tests, are you satisfied in the time it has taken to communicate the results?

  Day of enrollment

Secondary Outcomes (8)

• Confidence in Testing

  Day of Enrollment

• Intention to Self Isolate

  Day of enrollment

• Plan to Seek Care From Another Doctor or Healthcare Facility

  Day of enrollment

• Will Patient Plan for Work Absence

  Day of enrollment

• Did the Time to Receive Test Results Affect You and Prevent You From Doing Activities You Normally Would do?

  Day 7 after enrollment

Study Arms (2)

BioFire® Respiratory Panel 2.1-EZ

EXPERIMENTAL

EXP group will receive the BioFire RP2.1-EZ panel, designed to test for a variety of bacterial and/or viral causes for illness

Diagnostic Test: BioFire® Respiratory Panel 2.1-EZ

Standard of Care

NO INTERVENTION

Standard care procedures are essentially yes/no to patient having SARS-COV-2, the SC group will receive the standard nasal swab used in the IPCs.

Interventions

BioFire® Respiratory Panel 2.1-EZ DIAGNOSTIC_TEST

BioFire RP2.1-EZ Panel uses a syndromic approach to quickly identify SARS-CoV-2, along with 18 additional viral and bacterial pathogens in patients suspected of SARS-CoV-2. This PCR test provides results in about 45 minutes.

BioFire® Respiratory Panel 2.1-EZ

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>7
• Clinically stable
• Must present with one symptom of respiratory illness (e.g., cough, sneezing, runny or stuffy nose, sore throat, headaches, muscle aches, trouble breathing, shortness of breath, and/or fever).

You may not qualify if:

• Patient is unable to provide informed consent
• Chronic symptoms (\>14 days) or asymptomatic
• Unstable (or "too sick" to consent)
• Prisoner or ward of state
• Non-English speaker

Sponsors & Collaborators

• Andrew Meltzer: lead
• BioMérieux: collaborator

Study Sites (2)

GW Immediate & Primary Care - McPherson Square

Washington D.C., District of Columbia, 20005, United States

Location

GW Immediate & Primary Care - Rhode Island Ave

Washington D.C., District of Columbia, 20018, United States

Location

Related Publications (7)

• Dugas AF, Valsamakis A, Atreya MR, Thind K, Alarcon Manchego P, Faisal A, Gaydos CA, Rothman RE. Clinical diagnosis of influenza in the ED. Am J Emerg Med. 2015 Jun;33(6):770-5. doi: 10.1016/j.ajem.2015.03.008. Epub 2015 Mar 12.

  PMID: 25827595 BACKGROUND

• Beard K, Brendish N, Malachira A, Mills S, Chan C, Poole S, Clark T. Pragmatic multicentre randomised controlled trial evaluating the impact of a routine molecular point-of-care 'test-and-treat' strategy for influenza in adults hospitalised with acute respiratory illness (FluPOC): trial protocol. BMJ Open. 2019 Dec 17;9(12):e031674. doi: 10.1136/bmjopen-2019-031674.

  PMID: 31852699 BACKGROUND

• Kim DK, Poudel B. Tools to detect influenza virus. Yonsei Med J. 2013 May 1;54(3):560-6. doi: 10.3349/ymj.2013.54.3.560.

  PMID: 23549796 BACKGROUND

• Leber AL, Everhart K, Daly JA, Hopper A, Harrington A, Schreckenberger P, McKinley K, Jones M, Holmberg K, Kensinger B. Multicenter Evaluation of BioFire FilmArray Respiratory Panel 2 for Detection of Viruses and Bacteria in Nasopharyngeal Swab Samples. J Clin Microbiol. 2018 May 25;56(6):e01945-17. doi: 10.1128/JCM.01945-17. Print 2018 Jun.

  PMID: 29593057 BACKGROUND

• Overview of influenza testing methods. Centers for Disease Control and Prevention. https://www.cdc.gov/flu/professionals/diagnosis/overview-testing-methods.htm. Published August 31, 2020. Accessed October 12, 2021.

  BACKGROUND

• Poon SJ, Schuur JD, Mehrotra A. Trends in Visits to Acute Care Venues for Treatment of Low-Acuity Conditions in the United States From 2008 to 2015. JAMA Intern Med. 2018 Oct 1;178(10):1342-1349. doi: 10.1001/jamainternmed.2018.3205.

  PMID: 30193357 BACKGROUND

• Weinick RM, Burns RM, Mehrotra A. Many emergency department visits could be managed at urgent care centers and retail clinics. Health Aff (Millwood). 2010 Sep;29(9):1630-6. doi: 10.1377/hlthaff.2009.0748.

  PMID: 20820018 BACKGROUND

MeSH Terms

Conditions

Virus Diseases; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Andrew C. Meltzer
• Organization: The George Washington University

Ameltzer@mfa.gwu.edu

202-741-2952

Study Officials

• Andrew Meltzer, MD

  Clinical Research Director, Department of Emergency Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief, Clinical Research Section, Department of Emergency Medicine

Model Details: 1 to 1 RCT

Study Record Dates

• First Submitted: July 18, 2022
• First Posted: July 20, 2022
• Study Start: April 4, 2022
• Primary Completion: January 1, 2023
• Study Completion: June 1, 2023
• Last Updated: September 19, 2024
• Results First Posted: March 20, 2024

Record last verified: 2024-08

Locations

US (2)