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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Acute Respiratory Tract Infections

Intervention / Treatment
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* Diagnostic Test: FebriDx


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acute Respiratory Infection<br>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<br>* Point of Care Host Immune Response Test<br>|
| Asymptomatic Cohort<br>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<br>* Point of Care Host Immune Response Test<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Host Immune Response, Biomarker, Point-of-Care, Myxovirus Resistance Protein A (MxA), C-reactive Protein (CRP)