Evaluation of Diagnostic Accuracy and Clinical Performance of the UllCORE Bloodstream Infection (BSI) Test
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorDeepull Diagnostics S.L.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Unable to collect UllCORE BSI Test samples from the same venipuncture as blood culture (BC) samples
Patient was previously enrolled in the study
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
UllCORE BSI Test
Diagnostic testThe 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.
Treatment groups
1,500 Participants
are divided into 1 treatment groupGroup A: Participants with Suspected Bloodstream Infection or Sepsis1 intervention
Trial outcomes
Primary outcomes
1
Clinical Performance of the UllCORE Bloodstream Infection (BSI) Test Assessed by Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA)
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.
Time frame
From specimen collection through completion of investigational and comparator testing, up to 365 days after specimen collection.Sponsors and contacts
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Source ClinicalTrials.gov