DIStinguish Respiratory Underlying Pathogen associaTed Host Response in Acute Respiratory Infection: An Evaluation of FebriDx POC Test
Sponsor study identifier
observational
540
1 country
20
Study Start
October 15, 2019
Actual (reported)Primary Completion
April 30, 2021
Actual (reported)Study Completion
June 10, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 10, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 17, 2013
Actual (reported)December 23, 2013
Actual (reported)October 15, 2019
Actual (reported)April 30, 2021
Actual (reported)June 10, 2021
Actual (reported)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 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.
Study subjects will be 1 year of age and older presenting to emergency departments, urgent care centers and primary care offices without infection.
Point of Care Host Immune Response Test
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients presenting with a new onset, measured fever (exhibited or reported) and acute respiratory symptoms
University of Alabama
Birmingham, Alabama, 35294-0111, United States
AFC Urgent Care/Urgent Care Clinical Trials
Denver, Colorado, 80246, United States
Clinical Research of South Florida
Coral Gables, Florida, 33134, United States
Doral Medical Research
Hialeah, Florida, 33016, United States
PAS Research
Tampa, Florida, 33613, United States
Massachusetts General
Boston, Massachusetts, 02114, United States
Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
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.
Respiratory and blood specimens will be retained for future testing.
Nathan Shapiro, MD
Beth Israel Deaconess Medical Center
540 participants (actual enrollment reported by the registry).
First Submitted
December 17, 2013
First Posted
December 23, 2013
Study Start
October 15, 2019
Actual (reported)Point of Care Testing Using FebriDx in Primary Care: a Mixed Methods Feasibility Study
Contact the study team to confirm eligibility.
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
St. Vincent Hospital
Worcester, Massachusetts, 01608, United States
New York Methodist Hospital
Brooklyn, New York, 11215, United States
Woodruff Road Urgent Care Center/Urgent Care Clinical Trials
Easley, South Carolina, 29640, United States
Parkside Pediatrics
Greenville, South Carolina, 29607, United States
Woodruff Road Urgent Care Center, P.C./ Urgent Care Clinical Trials
Greenville, South Carolina, 29611, United States
AFC Urgent Care/Urgent Care Clinical Trials
Chattanooga, Tennessee, 37421, United States
Clinical Research Associates
Nashville, Tennessee, 37203, United States
VA Office of Research and Development/Vanderbilt University School of Medicine
Nashville, Tennessee, 37232, United States
Urgent Care Clinical Trials
Dallas, Texas, 75204, United States
Benchmark Research
San Angelo, Texas, 76904, United States
University of Wisconsin-Madison/Berbee Walsh Department of Emergency Medicine
Madison, Wisconsin, 53705, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
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.
Primary Completion
April 30, 2021
Actual (reported)Study Completion
June 10, 2021
Actual (reported)Last Updated
November 17, 2022
Record last verified: 2022-11
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Source: ClinicalTrials.gov.
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