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Life sciences · Observational Study
ClinicalTrials.gov · October 6, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Observational Study.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT07859852). This is a study registration, not published results. Lead sponsor: Deepull Diagnostics S.L.. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 1500 participants (ESTIMATED). Conditions: Blood Stream Infection, Blood Stream Infections, Sepsis, Fungemia, Bacteremia. Interventions: DIAGNOSTIC_TEST: UllCORE BSI Test. Primary outcome measures: Clinical Performance of the UllCORE ID BSI Test Assessed by Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) , From specimen collection through completion of investigational and comparator testing, up to 365 days after specimen collection.. Brief summary: This study is designed to evaluate the clinical performance of the UllCORE 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.