Not currently recruiting at UC Irvine

Evaluation of Diagnostic Accuracy and Clinical Performance of the UIICORE BSI Test

a study on Blood Stream Infection Sepsis Fungemia Bacteremia

Summary

Location
at Orange, California and other locations
Dates
study started
study ends around

Description

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.

Keywords

Blood Stream Infection, Blood Stream Infections, Sepsis, Fungemia, Bacteremia, Bloodstream infection, Blood culture, Molecular diagnostics, Molecular diagnostic testing, Whole blood, Pathogen detection, Antimicrobial resistance markers, Rapid diagnostic testing, Sepsis diagnosis, Direct-from-blood testing, Multiplex polymerase chain reaction, UllCORE BSI Test

Eligibility

You can join if…

  • Any age (where the remaining criteria can be safely fulfilled)
  • Ability to provide consent/assent in accordance with IRB/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 SOC.
  • Patient is able and an appropriate candidate to be able to collect 2 K2 EDTA tubes of whole blood.

You CAN'T join if...

  • Unable to collect UllCORE BSI Test samples from same venipuncture as BC samples
  • Patient was previously enrolled in the study

Locations

  • University of California at Irvine Medical Center not yet accepting patients
    Orange California 92868 United States
  • Baylor Scott & White Health Medical Center-Temple not yet accepting patients
    Temple Texas 76508 United States
  • University Hospitals Cleveland Medical Center accepting new patients
    Cleveland Ohio 44106 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Deepull Diagnostics S.L.
ID
NCT07859852
Study Type
Observational [Patient Registry]
Participants
Expecting 1500 study participants
Last Updated