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Evaluation of Diagnostic Accuracy and Clinical Performance of the UllCORE Bloodstream Infection (BSI) Test

Study acronym: B-RAPID
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Deepull Diagnostics S.L.

Record History

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  1. Primary endpoint(s) modified
    • Eligibility criteria expanded, about 12 words
    • Study title expanded, about 2 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07859852
Lead Sponsor Deepull Diagnostics S.L.
Conditions
(from sponsor)		 Blood Stream Infection, Blood Stream Infections, Sepsis, Fungemia, Bacteremia
Related terms Bacteremia, Fungemia, Sepsis
Enrollment 1,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov