An observational study in Blood Stream Infection, Blood Stream Infections and Sepsis, sponsored by Deepull Diagnostics S.L.. Recruiting at 20 sites in 5 countries. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by Deepull Diagnostics S.L. · Observational
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.
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 160 across 931 observational studies indexed under Sepsis.
Browse Sepsis studies →This is the only study on the registry with Deepull Diagnostics S.L. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Participants with suspected bloodstream infection or sepsis whose prospectively collected whole-blood specimens are either tested fresh using the investigational UllCORE 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.
Diagnostic Test: UllCORE BSI Test
The UllCORE 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.
Clinical Performance of the UllCORE ID BSI Test Assessed by Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA)
Clinical performance of the UllCORE ID 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.
Time frame: From specimen collection through completion of investigational and comparator testing, up to 365 days after specimen collection.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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