Clinical trial NCT02018198: FebriDx DISRUPT Acute Respiratory Infection Trial in Acute Respiratory Infection: An Evaluation of FebriDx® POC Test
Official title: DIStinguish Respiratory Underlying Pathogen associaTed Host Response in Acute Respiratory Infection: An Evaluation of FebriDx POC Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Respiratory Tract Infections
Keywords: Host Immune Response
Biomarker
Point-of-Care
Myxovirus Resistance Protein A (MxA)
C-reactive Protein (CRP)
Lead sponsor: Lumos Diagnostics
Sponsor class: INDUSTRY
First posted: 2013-12-23
Enrollment: 540
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting with a new onset, measured fever (exhibited or reported) and acute respiratory symptoms

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Denver
country: United States
facility: AFC Urgent Care/Urgent Care Clinical Trials
state: Colorado
city: Coral Gables
country: United States
facility: Clinical Research of South Florida
state: Florida
city: Hialeah
country: United States
facility: Doral Medical Research
state: Florida
city: Tampa
country: United States
facility: PAS Research
state: Florida
city: Boston
country: United States
facility: Massachusetts General
state: Massachusetts
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: St. Vincent Hospital
state: Massachusetts
city: Brooklyn
country: United States
facility: New York Methodist Hospital
state: New York
city: Easley
country: United States
facility: Woodruff Road Urgent Care Center/Urgent Care Clinical Trials
state: South Carolina
city: Greenville
country: United States
facility: Parkside Pediatrics
state: South Carolina
city: Greenville
country: United States
facility: Woodruff Road Urgent Care Center, P.C./ Urgent Care Clinical Trials
state: South Carolina
city: Chattanooga
country: United States
facility: AFC Urgent Care/Urgent Care Clinical Trials
state: Tennessee
city: Nashville
country: United States
facility: Clinical Research Associates
state: Tennessee
city: Nashville
country: United States
facility: VA Office of Research and Development/Vanderbilt University School of Medicine
state: Tennessee
city: Dallas
country: United States
facility: Urgent Care Clinical Trials
state: Texas
city: San Angelo
country: United States
facility: Benchmark Research
state: Texas
city: Madison
country: United States
facility: University of Wisconsin-Madison/Berbee Walsh Department of Emergency Medicine
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Nathan Shapiro, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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 confirmed fever. Ann Med. 2018 Aug;50(5):420-429. doi: 10.1080/07853890.2018.1474002. Epub 2018 May 18.
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):94. doi: 10.3390/jcm6100094.
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 Outpatient Setting. JAMA Netw Open. 2022 Oct 3;5(10):e2234588. doi: 10.1001/jamanetworkopen.2022.34588.