Evaluation of Diagnostic Accuracy and Clinical Performance of the UllCORE Bloodstream Infection (BSI) Test
Public ClinicalTrials.gov record NCT07859852. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT07859852
- Recruitment status
- Recruiting
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 1,500 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 21, 2026 (Actual)
- Primary completion
- Apr 2027 (Estimated)
- Completion
- Oct 2027 (Estimated)
- Last update posted
- Oct 8, 2026
2026 – 2027
United States locations
- U.S. sites
- 10
- U.S. states
- 10
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California at Irvine Medical Center | Orange | California | 92868 | Not yet recruiting |
| Tampa General Hospital | Tampa | Florida | 33606 | Not yet recruiting |
| The Johns Hopkins Hospital | Baltimore | Maryland | 21287 | Not yet recruiting |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | Not yet recruiting |
| Henry Ford Health | Novi | Michigan | 48374 | Not yet recruiting |
| Washington University School of Medicine | St Louis | Missouri | 63110 | Not yet recruiting |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | Recruiting |
| Geisinger Health | Danville | Pennsylvania | 17822 | Not yet recruiting |
| Vanderbilt health | Nashville | Tennessee | 37232 | Not yet recruiting |
| Baylor Scott & White Health Medical Center-Temple | Temple | Texas | 76508 | Not yet recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 10 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07859852, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 8, 2026 · Synced Oct 13, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07859852 live on ClinicalTrials.gov.