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

Acute Respiratory Tract Infections Clinical Trial

Official title:

DIStinguish Respiratory Underlying Pathogen associaTed Host Response in Acute Respiratory Infection: An Evaluation of FebriDx POC Test

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02018198
• Other study ID #: 13-0830
• Status: Completed
• Start date: October 15, 2019
• Est. completion date: June 10, 2021

Study information

• Verified date: November 2022
• Source: Lumos Diagnostics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This is a prospective, multi-center, observational, blinded clinical trial whereby consented study subjects will be enrolled into two study cohorts: an Acute Respiratory Infection cohort and an Asymptomatic cohort. Subjects (children/adolescents, adults and elderly) with suspected community acquired Acute Respiratory Infection will be enrolled in the Acute Respiratory Infection cohort and subjects without infectious illness will be enrolled in the Asymptomatic cohort. All subjects will undergo FebriDx testing (study device) and results, blinded to subjects and treating physicians, will be compared to a Clinical Reference Algorithm supervised by clinical experts to arbitrate the presence and type of infection (bacterial or viral); the experts are also blinded to the results of FebriDx testing.

The FebriDx® test is a rapid, point-of-care (POC) test that uses a fingerstick blood sample to identify patients with a pathogen induced host immune response through in-vitro detection of both Myxovirus resistance protein A (MxA) and c-reactive protein (CRP) directly from a whole blood sample. MxA is an intracellular protein that becomes elevated in the presence of acute viral infection and CRP is an acute-phase inflammatory protein that is elevated in the presence of a systemic bacterial and/or viral infection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 540
• Est. completion date: June 10, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year and older

Eligibility

Acute Respiratory Infection Cohort INCLUSION CRITERIA

• 1 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

Acute Respiratory Infection Cohort EXCLUSION CRITERIA

• 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

ASYMPTOMATIC COHORT INCLUSION CRITERIA

• 1 year of age or older

• Absence of infectious signs and symptoms

ASYMPTOMATIC COHORT EXCLUSION CRITERIA

• Fever greater than or equal to 100.5°F /38°C (oral or tympanic) in last 14 days

• Cough

• Chills

• Dyspnea

• Purulent Sputum

• Fatigue

• Pleuritic Pain

• Nasal congestion

• Rhinorrhea (runny nose)

• Sore throat

• Hoarse voice

• Earache

• Autoimmune or rheumatologic disease (e.g. undifferentiated connective tissue disease, Rheumatoid Arthritis, Systemic Lupus Erythematosus (and subsets of Lupus), Sjögren's syndrome, Systemic Sclerosis, Polymyositis and Dermatomyositis, Wegener's granulomatosis)

• Suspected of having any infection

• Receiving interferon therapy (e.g. MS, HIV, HBV, HCV) in last 30 days

• Immunocompromised state (e.g. HIV) or taking immunosuppressive (e.g. oral steroids, Methotrexate, Cyclosporine, Antimetabolite chemotherapy, interferon therapy) in the last 30 days

• Taking antibiotics or antiviral therapy in the last 30 days

• Received a live viral immunization in the last 30 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

• History of a myocardial infarction or stroke in the last 30 days

• Chronic bacterial infection or osteomyelitis

• Known chronic viral infections such as HIV, HCV, HBV, or CMV

• Active tuberculosis

• Acute or chronic (greater than 30 days) diarrhea and/or vomiting

• Urinary tract symptoms in the last 14 days

• Active diarrheal illness within the last 14 days

• Active skin, ocular, or neurologic infections

• Suspected of having otitis media

Related Conditions & MeSH terms

• Acute Respiratory Tract Infections
• Communicable Diseases
• Infections
• Respiratory Tract Infections

Intervention

Diagnostic Test:
• FebriDx
Point of Care Host Immune Response Test

Locations

Country	Name	City	State
United States	University of Alabama	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Massachusetts General	Boston	Massachusetts
United States	New York Methodist Hospital	Brooklyn	New York
United States	AFC Urgent Care/Urgent Care Clinical Trials	Chattanooga	Tennessee
United States	Clinical Research of South Florida	Coral Gables	Florida
United States	Urgent Care Clinical Trials	Dallas	Texas
United States	AFC Urgent Care/Urgent Care Clinical Trials	Denver	Colorado
United States	Woodruff Road Urgent Care Center/Urgent Care Clinical Trials	Easley	South Carolina
United States	Parkside Pediatrics	Greenville	South Carolina
United States	Woodruff Road Urgent Care Center, P.C./ Urgent Care Clinical Trials	Greenville	South Carolina
United States	Doral Medical Research	Hialeah	Florida
United States	University of Wisconsin-Madison/Berbee Walsh Department of Emergency Medicine	Madison	Wisconsin
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Clinical Research Associates	Nashville	Tennessee
United States	VA Office of Research and Development/Vanderbilt University School of Medicine	Nashville	Tennessee
United States	Benchmark Research	San Angelo	Texas
United States	PAS Research	Tampa	Florida
United States	St. Vincent Hospital	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Rapid Pathogen Screening

Country where clinical trial is conducted

United States, 

References & 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 201 — View Citation

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). pii: E94. doi: 10.339 — View Citation

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 Outpatien — View Citation

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 conf — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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