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A Rapid Test for Acute Respiratory Illness (Radical)

22. maj 2020 opdateret af: Duke University

Evaluation of a Rapid Diagnostic Test for the Categorization of Acute Respiratory Illness

The primary purpose of this study is to support the development of a host response test for acute respiratory illness to identify bacterial, viral or NB/NV etiologies as compared to a clinical adjudication reference standard.

Secondary objectives include:

  1. Evaluate the effect of age on the performance of the HR-ARI test
  2. Evaluate the effect of race/ethnicity on the performance of the HR-ARI test
  3. Evaluate the effect of geography on the performance of the HR-ARI test

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The primary purpose of this study is to support the development of a host response test for acute respiratory illness to identify bacterial, viral or NB/NV etiologies as compared to a clinical adjudication reference standard.

Secondary objectives include:

  1. Evaluate the effect of age on the performance of the HR-ARI test
  2. Evaluate the effect of race/ethnicity on the performance of the HR-ARI test
  3. Evaluate the effect of geography on the performance of the HR-ARI test

Subjects will be identified in the Emergency Department of participating hospitals. Samples including nasopharyngeal swab, throat swab, blood, and urine will be obtained.

A case report form for each subject will be completed to include information regarding clinical characteristics, signs and symptoms of infection, presence of complications, and patient outcome. Baseline characteristics including preexisting conditions. Survival data will also be collected for each subject.

Samples collected will be used to characterize the patient's illness as either infectious or not, and if infectious, either bacterial or viral. Samples will also be used to measure changes in gene expression, referred to as the Host Response-Acute Respiratory Illness (HR-ARI) test.

The result of this test will be made in comparison to a retrospective review of the subject's clinical information. Results will not be used for any interventions and will not be released to subjects or their providers.

Because the study procedure includes only sample and data collection, the risks will be minimal and no different than encountered during routine clinical care.

The study was re-assessed in 2020 and applicable updates were made to the record.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

783

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Davis, California, Forenede Stater, 95616
        • The University of California- Davis
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115
        • Brigham and Women's Hospital
      • Newton, Massachusetts, Forenede Stater, 02462
        • Newton-Wellesley Hospital
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48202
        • Henry Ford Hospital
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27514
        • The University of North Carolina at Chapel Hill
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke University Medical Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15224
        • Children's Hospital of Pittsburgh
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02903
        • Rhode Island/Lifespan
    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • The University of Texas- Houston
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84132
        • University of Utah Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

2 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Up to 750 subjects may be enrolled at a minimum of 3 study sites from geographically diverse locations across the US. Subjects will be approached based on symptoms upon presentation to the health care facility's ED. In addition to these subjects, data from 450 previously enrolled subjects will be used. All demographic groups will have access to enrollment because anyone with acute respiratory infection (ARI) will be approached. Foreign language speaking subjects may be enrolled following review and approval of the appropriate consent process and documents by the reviewing IRB.

Beskrivelse

Inclusion Criteria:

A. Age 24 months or older

B. Acute respiratory illness of less than 28 days in duration.

C. Acute respiratory illness will be defined by at least two qualifying symptoms OR one qualifying symptom and at least 1 qualifying vital sign abnormality:

  • Qualifying symptoms:Headache, rhinorrhea, nasal congestion, sneezing, sore throat, itchy or watery eyes, conjunctivitis, cough, shortness of breath, sputum production, chest pain, wheezing
  • Qualifying Vital Signs: Age greater than or equal to 2 and less than 6:Tachycardia (HR greater than or equal to 110), Tachynpnea (RR greater than or equal to 20),Temperature greater than or equal to 38.5 degrees Celsius or less than or equal to 36 degrees Celsius. Age greater than or equal to 6: Tachycardia(HR greater than or equal to 90), Tachynpnea (RR greater than or equal to 20), Temperature greater than or equal to 38.5 degrees Celsius or less than or equal to 36 degrees Celsius.

D. Ability of the subject or legally authorized representative/parent to understand study procedures, and willing and able to comply with all required.

Exclusion Criteria:

A. Known or suspected infection at any other anatomic site requiring antibacterial therapy.

B. Any specific condition that in the judgment of the referring provider or the site investigator precludes participation because it could affect subject safety or ability of subject to participate in this trial.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Subjects with Acute Respiratory Illness
Patients with acute respiratory illness identified in the Emergency Department
Diagnostisk test: Host Gene Expression
comparison to retrospective clinical adjudication
Andre navne:
  • Adjudication

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Positive predictive value with reference standard (PPV)
Tidsramme: Day 1
Number of assay positives that agree with the reference standard / [Number of assay positives that agree with the reference standard + Number of assay positives that disagree with the reference standard]
Day 1
Negative predictive value with the reference standard (NPV)
Tidsramme: Day 1
Number of assay negatives that agree with the reference standard / [number of assay negatives that agree with the reference standard + number of assay negatives that disagree with the reference standard]
Day 1

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall agreement with the reference standard (OA)
Tidsramme: Day 1
Number of samples that agree with the reference standard / all samples tested
Day 1

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Duke University

Samarbejdspartnere

Antibacterial Resistance Leadership Group

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

17. juli 2017

Primær færdiggørelse (Faktiske)

6. september 2019

Studieafslutning (Faktiske)

19. december 2019

Datoer for studieregistrering

Først indsendt

16. juni 2017

Først indsendt, der opfyldte QC-kriterier

16. juni 2017

Først opslået (Faktiske)

19. juni 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. maj 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. maj 2020

Sidst verificeret

1. maj 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Pro00082317
  • Pro00082322 (Anden identifikator: Duke UMC)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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Kliniske forsøg med Bakterielle infektioner

Kliniske forsøg med Host Gene Expression

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Equatorial Guinea

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner