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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Roger Canton
- Numéro de téléphone: +34 936553530
- E-mail: rcanton@deepull.com
Lieux d'étude
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Berlin-Zehlendorf, Allemagne, 12203
- Pas encore de recrutement
- Charité - Campus Benjamin Franklin
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Jena, Allemagne, 07443
- Pas encore de recrutement
- Universitaetsklinikum Jena
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Leipzig, Allemagne, 04103
- Pas encore de recrutement
- Universitaetsklinikum Leipzig
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Badalona, Espagne
- Pas encore de recrutement
- Hospital Germans Trias I Pujol
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Barcelona, Espagne, 08036
- Pas encore de recrutement
- Hospital Clínic de Barcelona
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Barcelona, Espagne, 08035
- Pas encore de recrutement
- Hospital Universitari Vall d'Hebron - VHIO
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Limoges, France, 87000
- Pas encore de recrutement
- CHU de Limoges - Hôpital Dupuytren
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Lyon, France, 69004
- Pas encore de recrutement
- Hôpital de la Croix-Rousse - HCL
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Florence, Italie, 50134
- Pas encore de recrutement
- Azienda Ospedaliera Universitaria Careggi
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Perugia, Italie, 06129
- Pas encore de recrutement
- Ospedale di Perugia Santa Maria della Misericordia
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California
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Orange, California, États-Unis, 92868
- Pas encore de recrutement
- University of California at Irvine Medical Center
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Florida
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Tampa, Florida, États-Unis, 33606
- Pas encore de recrutement
- Tampa General Hospital
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Maryland
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Baltimore, Maryland, États-Unis, 21287
- Pas encore de recrutement
- The Johns Hopkins Hospital
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Massachusetts
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Boston, Massachusetts, États-Unis, 02215
- Pas encore de recrutement
- Beth Israel Deaconess Medical Center
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Michigan
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Novi, Michigan, États-Unis, 48374
- Pas encore de recrutement
- Henry Ford Health
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Missouri
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St Louis, Missouri, États-Unis, 63110
- Pas encore de recrutement
- Washington University School of Medicine
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Ohio
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Cleveland, Ohio, États-Unis, 44106
- Recrutement
- University Hospitals Cleveland Medical Center
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Pennsylvania
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Danville, Pennsylvania, États-Unis, 17822
- Pas encore de recrutement
- Geisinger Health
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Tennessee
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Nashville, Tennessee, États-Unis, 37232
- Pas encore de recrutement
- Vanderbilt health
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Texas
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Temple, Texas, États-Unis, 76508
- Pas encore de recrutement
- Baylor Scott & White Health Medical Center-Temple
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
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.
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
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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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Clinical Performance of the UllCORE Bloodstream Infection (BSI) Test Assessed by Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA)
Délai: 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.
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- PE-REC-2508
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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