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

October 5, 2026 updated by: Deepull Diagnostics S.L.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Limoges, France, 87000
        • Not yet recruiting
        • CHU de Limoges - Hôpital Dupuytren
      • Lyon, France, 69004
        • Not yet recruiting
        • Hôpital de la Croix-Rousse - HCL
  • Germany
      • Berlin-Zehlendorf, Germany, 12203
        • Not yet recruiting
        • Charité - Campus Benjamin Franklin
      • Jena, Germany, 07443
        • Not yet recruiting
        • Universitaetsklinikum Jena
      • Leipzig, Germany, 04103
        • Not yet recruiting
        • Universitaetsklinikum Leipzig
  • Italy
      • Florence, Italy, 50134
        • Not yet recruiting
        • Azienda Ospedaliera Universitaria Careggi
      • Perugia, Italy, 06129
        • Not yet recruiting
        • Ospedale di Perugia Santa Maria della Misericordia
  • Spain
      • Badalona, Spain
        • Not yet recruiting
        • Hospital Germans Trias I Pujol
      • Barcelona, Spain, 08036
        • Not yet recruiting
        • Hospital Clínic de Barcelona
      • Barcelona, Spain, 08035
        • Not yet recruiting
        • Hospital Universitari Vall d'Hebron - VHIO
  • United States
    • California
      • Orange, California, United States, 92868
        • Not yet recruiting
        • University of California at Irvine Medical Center
    • Florida
      • Tampa, Florida, United States, 33606
        • Not yet recruiting
        • Tampa General Hospital
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Not yet recruiting
        • The Johns Hopkins Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Not yet recruiting
        • Beth Israel Deaconess Medical Center
    • Michigan
      • Novi, Michigan, United States, 48374
        • Not yet recruiting
        • Henry Ford Health
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Not yet recruiting
        • Washington University School of Medicine
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals Cleveland Medical Center
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Not yet recruiting
        • Geisinger Health
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Not yet recruiting
        • Vanderbilt health
    • Texas
      • Temple, Texas, United States, 76508
        • Not yet recruiting
        • Baylor Scott & White Health Medical Center-Temple

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study 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.

Description

Inclusion Criteria:

  • 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.

Planned blood culture collection and laboratory analysis as per standard of care (SOC).

• Patient is able and an appropriate candidate to be able to collect 2 K2 ethylenediaminetetraacetic acid (EDTA) tubes of whole blood.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants with Suspected Bloodstream Infection or Sepsis

Participants with suspected bloodstream infection or sepsis whose prospectively collected whole-blood specimens are either tested fresh using the investigational UllCORE Bloodstream Infection (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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Performance of the UllCORE Bloodstream Infection (BSI) Test Assessed by Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA)
Time Frame: From specimen collection through completion of investigational and comparator testing, up to 365 days after specimen collection.

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.
From specimen collection through completion of investigational and comparator testing, up to 365 days after specimen collection.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deepull Diagnostics S.L.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

September 30, 2026

First Submitted That Met QC Criteria

September 30, 2026

First Posted (Actual)

October 6, 2026

Study Record Updates

Last Update Posted (Actual)

October 8, 2026

Last Update Submitted That Met QC Criteria

October 5, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PE-REC-2508

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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