Recruiting

UllCORE BSI Test

Sponsor:

Deepull Diagnostics S.L.

Code:

NCT07859852

Conditions

Blood Stream Infection

Blood Stream Infections

Sepsis

Fungemia

Bacteremia

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

UllCORE BSI Test

Study Details

Brief 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.

Conditions

Blood Stream Infection

Blood Stream Infections

Sepsis

Fungemia

Bacteremia

Study ID

NCT07859852

Start date

Sep 21, 2026

Status verified date

Sep, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Design

Enrollment

1500 participants

Anticipated

Interventions and Outcome Measures

Arms

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 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.

Interventions

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.

Primary outcome measure

  • Clinical Performance of the UllCORE ID 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. ]

Central Contacts and Locations

Central contacts

Roger Canton

936553530rcanton@deepull.com

Locations

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

More Information

Sponsor

Deepull Diagnostics S.L.

Last update posted

Oct 6, 2026

Last verified

Sep, 2026

Keywords

  • 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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-07. This information was provided to ClinicalTrials.gov by Deepull Diagnostics S.L. on 2026-10-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.