Evaluation of Diagnostic Accuracy and Clinical Performance of the UllCORE Bloodstream Infection (BSI) Test (B-RAPID)
This study is designed to evaluate the clinical performance of the UllCORE Bloodstream Infection (BSI) Test, an investigational molecular diagnostic test intended to detect microorganisms and selected antimicrobial resistance markers directly from whole blood in patients with suspected bloodstream infection or sepsis.
Participants enrolled in the study will have blood collected at the same time as blood samples obtained for standard-of-care blood culture testing. Study blood samples will be tested using the UllCORE BSI Test either as fresh samples or after frozen storage, according to the study protocol.
The results of the UllCORE BSI Test will be compared with standard-of-care microbiology results and, when applicable, additional testing methods to assess the diagnostic performance of the investigational test.
The UllCORE BSI Test results will not be used to guide patient care and will not be provided to treating healthcare professionals for clinical decision-making. Participation in the study will therefore not change the standard medical care received by participants.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Roger Canton
- Telefonnummer: +34 936553530
- E-mail: rcanton@deepull.com
Studiesteder
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California
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Orange, California, Forenede Stater, 92868
- Ikke rekrutterer endnu
- University of California at Irvine Medical Center
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Florida
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Tampa, Florida, Forenede Stater, 33606
- Ikke rekrutterer endnu
- Tampa General Hospital
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Maryland
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Baltimore, Maryland, Forenede Stater, 21287
- Ikke rekrutterer endnu
- The Johns Hopkins Hospital
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02215
- Ikke rekrutterer endnu
- Beth Israel Deaconess Medical Center
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Michigan
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Novi, Michigan, Forenede Stater, 48374
- Ikke rekrutterer endnu
- Henry Ford Health
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Missouri
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St Louis, Missouri, Forenede Stater, 63110
- Ikke rekrutterer endnu
- Washington University School of Medicine
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Ohio
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Cleveland, Ohio, Forenede Stater, 44106
- Rekruttering
- University Hospitals Cleveland Medical Center
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Pennsylvania
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Danville, Pennsylvania, Forenede Stater, 17822
- Ikke rekrutterer endnu
- Geisinger Health
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37232
- Ikke rekrutterer endnu
- Vanderbilt health
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Texas
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Temple, Texas, Forenede Stater, 76508
- Ikke rekrutterer endnu
- Baylor Scott & White Health Medical Center-Temple
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Limoges, Frankrig, 87000
- Ikke rekrutterer endnu
- CHU de Limoges - Hôpital Dupuytren
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Lyon, Frankrig, 69004
- Ikke rekrutterer endnu
- Hôpital de la Croix-Rousse - HCL
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Florence, Italien, 50134
- Ikke rekrutterer endnu
- Azienda Ospedaliera Universitaria Careggi
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Perugia, Italien, 06129
- Ikke rekrutterer endnu
- Ospedale di Perugia Santa Maria della Misericordia
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Badalona, Spanien
- Ikke rekrutterer endnu
- Hospital Germans Trias I Pujol
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Barcelona, Spanien, 08036
- Ikke rekrutterer endnu
- Hospital Clínic de Barcelona
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Barcelona, Spanien, 08035
- Ikke rekrutterer endnu
- Hospital Universitari Vall d'Hebron - VHIO
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Berlin-Zehlendorf, Tyskland, 12203
- Ikke rekrutterer endnu
- Charité - Campus Benjamin Franklin
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Jena, Tyskland, 07443
- Ikke rekrutterer endnu
- Universitaetsklinikum Jena
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Leipzig, Tyskland, 04103
- Ikke rekrutterer endnu
- Universitaetsklinikum Leipzig
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
The study population will consist of patients with suspected bloodstream infection (BSI) or sepsis who are undergoing standard-of-care blood culture testing. Participants will be recruited from Emergency Departments and Intensive Care Units.
Eligible patients will be identified based on clinical signs and symptoms consistent with suspected BSI or sepsis, such as fever, elevated inflammatory markers, hypotension, or other clinical findings prompting blood culture collection. Participants meeting the eligibility criteria will be enrolled prospectively and consecutively, without preference for specific demographic or clinical characteristics.
Beskrivelse
Inclusion Criteria:
- Any age (where the remaining criteria can be safely fulfilled)
- Ability to provide consent/assent in accordance with Institutional Review Board (IRB)/Ethics Committee (EC) determinations
- The patient is presenting with signs and symptoms of suspected bloodstream infection (BSI) or fulfils the criteria for the hospital sepsis protocol.
Planned blood culture collection and laboratory analysis as per standard of care (SOC).
• Patient is able and an appropriate candidate to be able to collect 2 K2 ethylenediaminetetraacetic acid (EDTA) tubes of whole blood.
Exclusion Criteria:
- Unable to collect UllCORE BSI Test samples from the same venipuncture as blood culture (BC) samples
- Patient was previously enrolled in the study
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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Participants with Suspected Bloodstream Infection or Sepsis
Participants with suspected bloodstream infection or sepsis whose prospectively collected whole-blood specimens are either tested fresh using the investigational UllCORE Bloodstream Infection (BSI) Test or stored frozen before subsequent testing. UllCORE BSI Test results will be compared with standard-of-care microbiology results and will not be used for clinical decision-making. |
The UllCORE Bloodstream Infection (BSI) Test is an investigational molecular diagnostic test designed to detect microorganisms and selected antimicrobial resistance markers directly from whole blood. In this study, prospectively collected whole blood specimens will be tested either fresh or after frozen storage, according to the study protocol. UllCORE BSI Test results will be compared with standard-of-care microbiology results and will not be used for clinical decision-making. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Clinical Performance of the UllCORE Bloodstream Infection (BSI) Test Assessed by Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA)
Tidsramme: From specimen collection through completion of investigational and comparator testing, up to 365 days after specimen collection.
|
Clinical performance of the UllCORE Bloodstream Infection (BSI) Test will be assessed using positive percent agreement (PPA) and negative percent agreement (NPA) compared with standard-of-care microbiological methods, as applicable. Performance will be evaluated for the microorganisms and antimicrobial resistance markers included in the test panel. |
From specimen collection through completion of investigational and comparator testing, up to 365 days after specimen collection.
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PE-REC-2508
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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