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Acute Respiratory Tract InfectionsNCT02018198

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

An observational study of Acute Respiratory Tract Infections, run by Rapid Pathogen Screening at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 1 year and olderHealthy volunteers can take part
Conditions the study is for
Acute Respiratory Tract Infections
What is being tested?
FebriDx
How many people
540 participants
Where
20 sitesUnited States
Study dates
15 Oct 2019to 10 Jun 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Patients presenting with a new onset, measured fever (exhibited or reported) and acute respiratory symptoms

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

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

United States20 sites

  • University of Alabama

    Birmingham, Alabama, 35294-0111

  • Massachusetts General

    Boston, Massachusetts, 02114

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • New York Methodist Hospital

    Brooklyn, New York, 11215

  • AFC Urgent Care/Urgent Care Clinical Trials

    Chattanooga, Tennessee, 37421

  • Clinical Research of South Florida

    Coral Gables, Florida, 33134

  • Urgent Care Clinical Trials

    Dallas, Texas, 75204

  • AFC Urgent Care/Urgent Care Clinical Trials

    Denver, Colorado, 80246

  • Woodruff Road Urgent Care Center/Urgent Care Clinical Trials

    Easley, South Carolina, 29640

  • Parkside Pediatrics

    Greenville, South Carolina, 29607

  • Woodruff Road Urgent Care Center, P.C./ Urgent Care Clinical Trials

    Greenville, South Carolina, 29611

  • Doral Medical Research

    Hialeah, Florida, 33016

  • University of Wisconsin-Madison/Berbee Walsh Department of Emergency Medicine

    Madison, Wisconsin, 53705

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Clinical Research Associates

    Nashville, Tennessee, 37203

  • VA Office of Research and Development/Vanderbilt University School of Medicine

    Nashville, Tennessee, 37232

  • Benchmark Research

    San Angelo, Texas, 76904

  • PAS Research

    Tampa, Florida, 33613

  • St. Vincent Hospital

    Worcester, Massachusetts, 01608

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
FebriDx
Keywords
Host Immune Response, Biomarker, Point-of-Care, Myxovirus Resistance Protein A (MxA), C-reactive Protein (CRP)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FebriDxDiagnostic test

    Point of Care Host Immune Response Test

Study groups in NCT02018198
Study groupRoleWhat they receive
Acute Respiratory InfectionStudy 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.
Receives: Diagnostic Test: FebriDx
Asymptomatic CohortStudy subjects will be 1 year of age and older presenting to emergency departments, urgent care centers and primary care offices without infection.
Receives: Diagnostic Test: FebriDx

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2013 (estimated)
  2. Study start15 Oct 2019
  3. Primary completion30 Apr 2021
  4. Study completion10 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
540 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02018198
Sponsor's protocol ID
13-0830
Status last verified
Nov 2022
First submitted
17 Dec 2013
Last updated
17 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 29479553

  • 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.

    PubMed 29775092

  • 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.

    PubMed 28991170

  • 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.

    PubMed 36255727

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Respiratory Tract Infections, run by Rapid Pathogen Screening at 20 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: 10 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02018198, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2022.

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