FebriDx DISRUPT Acute Respiratory Infection Trial in Acute Respiratory Infection: An Evaluation of FebriDx® POC Test

NCT02018198 | Completed FDA Device

• 1 other identifier: 13-0830
• Study Type: observational
• Target: 540
• Locations: 1 country
• Sites: 20

Brief Summary

The aim of this study is to determine performance characteristics of the FebriDx test in predicting viral or bacterial infection etiology among febrile (observed or reported) patients presenting the emergency department, urgent care centers or primary care offices with suspected acute respiratory tract infection.

Conditions

Acute Respiratory Tract Infections

Keywords

Host Immune Response; Biomarker; Point-of-Care; Myxovirus Resistance Protein A (MxA); C-reactive Protein (CRP)

Outcome Measures

Primary Outcomes (1)

• The primary outcome is the presence of a bacterial associated systemic host immune response or viral associated systemic host immune response related to an acute community acquired febrile acute respiratory tract infection, as compared to final diagnosis

  The primary analysis will determine performance characteristics of the FebriDx® test by assessing negative and positive agreement of the FebriDx® results in determining the presence of a bacterial associated systemic host immune response or viral associated systemic host immune response compared with a Clinical Reference Algorithm (comparator method) that is supervised by clinical experts.

  10 minutes

Study Arms (2)

Acute Respiratory Infection

Study subjects will be 1 year of age and older presenting to emergency departments, urgent care centers and primary care offices with a new onset, measured fever and new onset respiratory symptoms.

Diagnostic Test: FebriDx

Asymptomatic Cohort

Study subjects will be 1 year of age and older presenting to emergency departments, urgent care centers and primary care offices without infection.

Diagnostic Test: FebriDx

Interventions

FebriDx DIAGNOSTIC_TEST

Point of Care Host Immune Response Test

Acute Respiratory Infection; Asymptomatic Cohort

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting with a new onset, measured fever (exhibited or reported) and acute respiratory symptoms

You may qualify if:

• year of age or older
• Exhibit or report of a new onset measured temperature (oral or tympanic) of greater than or equal to 100.5°F/38°C within 3 days (72 hours) of enrollment
• Clinical suspicion for Acute Respiratory Infection and presents with at least one of the following new onset of symptoms: runny nose, nasal congestion, sore throat, cough, hoarse voice or shortness of breath beginning within 7 days before enrollment

You may not qualify if:

• Incomplete or invalid testing for comparator method
• Unwilling to participate
• Receiving interferon therapy (e.g. MS, HIV, HBV, HCV) in the last 30 days
• Immunocompromised state (e.g. HIV) or taking immunosuppressive or chemotherapeutic medications in the last 30 days (e.g. oral steroids, Methotrexate, Cyclosporine, Antimetabolite chemotherapy, interferon therapy)
• Taking antibiotics or antiviral therapy in the last 14 days
• Received a live viral immunization in the last 14 days
• Significant trauma or burns (\> 5% total body surface area or full thickness (3rd°)) in the last 30 days
• Major surgery (requiring intravenous anesthesia and/or respiratory assistance) in the last 30 days
• Chronic fever without associated respiratory symptoms of greater than 7 days
• History of ear pain plus an exam consistent with otitis media within the last 14 days
• History of a myocardial infarction or stroke in the last 30 days
• year of age or older
• Absence of infectious signs and symptoms
• Fever greater than or equal to 100.5°F /38°C (oral or tympanic) in last 14 days
• Cough

Sponsors & Collaborators

• Rapid Pathogen Screening: lead

Study Sites (20)

University of Alabama

Birmingham, Alabama, 35294-0111, United States

Location

AFC Urgent Care/Urgent Care Clinical Trials

Denver, Colorado, 80246, United States

Location

Clinical Research of South Florida

Coral Gables, Florida, 33134, United States

Location

Doral Medical Research

Hialeah, Florida, 33016, United States

Location

PAS Research

Tampa, Florida, 33613, United States

Location

Massachusetts General

Boston, Massachusetts, 02114, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

St. Vincent Hospital

Worcester, Massachusetts, 01608, United States

Location

New York Methodist Hospital

Brooklyn, New York, 11215, United States

Location

Woodruff Road Urgent Care Center/Urgent Care Clinical Trials

Easley, South Carolina, 29640, United States

Location

Parkside Pediatrics

Greenville, South Carolina, 29607, United States

Location

Woodruff Road Urgent Care Center, P.C./ Urgent Care Clinical Trials

Greenville, South Carolina, 29611, United States

Location

AFC Urgent Care/Urgent Care Clinical Trials

Chattanooga, Tennessee, 37421, United States

Location

Clinical Research Associates

Nashville, Tennessee, 37203, United States

Location

VA Office of Research and Development/Vanderbilt University School of Medicine

Nashville, Tennessee, 37232, United States

Location

Urgent Care Clinical Trials

Dallas, Texas, 75204, United States

Location

Benchmark Research

San Angelo, Texas, 76904, United States

Location

University of Wisconsin-Madison/Berbee Walsh Department of Emergency Medicine

Madison, Wisconsin, 53705, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (4)

• Joseph P, Godofsky E. Outpatient Antibiotic Stewardship: A Growing Frontier-Combining Myxovirus Resistance Protein A With Other Biomarkers to Improve Antibiotic Use. Open Forum Infect Dis. 2018 Feb 15;5(2):ofy024. doi: 10.1093/ofid/ofy024. eCollection 2018 Feb.

  PMID: 29479553 RESULT

• Shapiro NI, Self WH, Rosen J, Sharp SC, Filbin MR, Hou PC, Parekh AD, Kurz MC, Sambursky R. A prospective, multi-centre US clinical trial to determine accuracy of FebriDx point-of-care testing for acute upper respiratory infections with and without a confirmed fever. Ann Med. 2018 Aug;50(5):420-429. doi: 10.1080/07853890.2018.1474002. Epub 2018 May 18.

  PMID: 29775092 RESULT

• Self WH, Rosen J, Sharp SC, Filbin MR, Hou PC, Parekh AD, Kurz MC, Shapiro NI. Diagnostic Accuracy of FebriDx: A Rapid Test to Detect Immune Responses to Viral and Bacterial Upper Respiratory Infections. J Clin Med. 2017 Oct 7;6(10):94. doi: 10.3390/jcm6100094.

  PMID: 28991170 RESULT

• Shapiro NI, Filbin MR, Hou PC, Kurz MC, Han JH, Aufderheide TP, Ward MA, Pulia MS, Birkhahn RH, Diaz JL, Hughes TL, Harsch MR, Bell A, Suarez-Cuervo C, Sambursky R. Diagnostic Accuracy of a Bacterial and Viral Biomarker Point-of-Care Test in the Outpatient Setting. JAMA Netw Open. 2022 Oct 3;5(10):e2234588. doi: 10.1001/jamanetworkopen.2022.34588.

  PMID: 36255727 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Respiratory and blood specimens will be retained for future testing.

Study Officials

• Nathan Shapiro, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2013
• First Posted: December 23, 2013
• Study Start: October 15, 2019
• Primary Completion: April 30, 2021
• Study Completion: June 10, 2021
• Last Updated: November 17, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (20)