FebriDx DISRUPT Acute Respiratory Infection Trial in Acute Respiratory Infection: An Evaluation of FebriDx® POC Test
NCT ID: NCT02018198
Last Updated: 2022-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
540 participants
OBSERVATIONAL
2019-10-15
2021-06-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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.
FebriDx
Point of Care Host Immune Response Test
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.
FebriDx
Point of Care Host Immune Response Test
Interventions
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FebriDx
Point of Care Host Immune Response Test
Eligibility Criteria
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Inclusion Criteria
* 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
* 1 year of age or older
* Absence of infectious signs and symptoms
Exclusion Criteria
* 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
* 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
1 Year
ALL
Yes
Sponsors
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Rapid Pathogen Screening
INDUSTRY
Responsible Party
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Principal Investigators
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Nathan Shapiro, MD
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center
Locations
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University of Alabama
Birmingham, Alabama, United States
AFC Urgent Care/Urgent Care Clinical Trials
Denver, Colorado, United States
Clinical Research of South Florida
Coral Gables, Florida, United States
Doral Medical Research
Hialeah, Florida, United States
PAS Research
Tampa, Florida, United States
Massachusetts General
Boston, Massachusetts, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
St. Vincent Hospital
Worcester, Massachusetts, United States
New York Methodist Hospital
Brooklyn, New York, 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
AFC Urgent Care/Urgent Care Clinical Trials
Chattanooga, Tennessee, United States
Clinical Research Associates
Nashville, Tennessee, United States
VA Office of Research and Development/Vanderbilt University School of Medicine
Nashville, Tennessee, United States
Urgent Care Clinical Trials
Dallas, Texas, United States
Benchmark Research
San Angelo, Texas, United States
University of Wisconsin-Madison/Berbee Walsh Department of Emergency Medicine
Madison, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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13-0830
Identifier Type: -
Identifier Source: org_study_id
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