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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Roger Canton
- Telefonnummer: +34 936553530
- E-post: rcanton@deepull.com
Studiesteder
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California
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Orange, California, Forente stater, 92868
- Har ikke rekruttert ennå
- University of California at Irvine Medical Center
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Florida
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Tampa, Florida, Forente stater, 33606
- Har ikke rekruttert ennå
- Tampa General Hospital
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Maryland
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Baltimore, Maryland, Forente stater, 21287
- Har ikke rekruttert ennå
- The Johns Hopkins Hospital
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Massachusetts
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Boston, Massachusetts, Forente stater, 02215
- Har ikke rekruttert ennå
- Beth Israel Deaconess Medical Center
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Michigan
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Novi, Michigan, Forente stater, 48374
- Har ikke rekruttert ennå
- Henry Ford Health
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Missouri
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St Louis, Missouri, Forente stater, 63110
- Har ikke rekruttert ennå
- Washington University School of Medicine
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Ohio
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Cleveland, Ohio, Forente stater, 44106
- Rekruttering
- University Hospitals Cleveland Medical Center
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Pennsylvania
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Danville, Pennsylvania, Forente stater, 17822
- Har ikke rekruttert ennå
- Geisinger Health
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Tennessee
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Nashville, Tennessee, Forente stater, 37232
- Har ikke rekruttert ennå
- Vanderbilt health
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Texas
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Temple, Texas, Forente stater, 76508
- Har ikke rekruttert ennå
- Baylor Scott & White Health Medical Center-Temple
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Limoges, Frankrike, 87000
- Har ikke rekruttert ennå
- CHU de Limoges - Hôpital Dupuytren
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Lyon, Frankrike, 69004
- Har ikke rekruttert ennå
- Hôpital de la Croix-Rousse - HCL
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Florence, Italia, 50134
- Har ikke rekruttert ennå
- Azienda Ospedaliera Universitaria Careggi
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Perugia, Italia, 06129
- Har ikke rekruttert ennå
- Ospedale di Perugia Santa Maria della Misericordia
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Badalona, Spania
- Har ikke rekruttert ennå
- Hospital Germans Trias I Pujol
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Barcelona, Spania, 08036
- Har ikke rekruttert ennå
- Hospital Clínic de Barcelona
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Barcelona, Spania, 08035
- Har ikke rekruttert ennå
- Hospital Universitari Vall d'Hebron - VHIO
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Berlin-Zehlendorf, Tyskland, 12203
- Har ikke rekruttert ennå
- Charité - Campus Benjamin Franklin
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Jena, Tyskland, 07443
- Har ikke rekruttert ennå
- Universitaetsklinikum Jena
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Leipzig, Tyskland, 04103
- Har ikke rekruttert ennå
- Universitaetsklinikum Leipzig
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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 studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
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.
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PE-REC-2508
Plan for individuelle deltakerdata (IPD)
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