UllCORE BSI Test for Bloodstream Infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study compares the UllCORE BSI Test results from whole blood with standard blood culture results in patients with suspected bloodstream infection or sepsis. Samples are collected at the same time as routine blood cultures and tested either fresh or after freezing, following a predefined protocol. The goal is to characterize the diagnostic performance of the investigational test without using its results to guide patient care. Data from multiple sites, including UC Irvine Medical Center, Tampa General Hospital, and Johns Hopkins Hospital, will support sensitivity, specificity, and concordance analyses against conventional microbiology methods. No clinical decisions will be made based on UllCORE BSI Test results for this study.

Why it matters

Who can join: the full rules

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

Where it's running

• University Hospitals Cleveland Medical Center
  Cleveland, Ohio, United States Recruiting
• University of California at Irvine Medical Center
  Orange, California, United States Not yet recruiting
• Tampa General Hospital
  Tampa, Florida, United States Not yet recruiting
• The Johns Hopkins Hospital
  Baltimore, Maryland, United States Not yet recruiting
• Beth Israel Deaconess Medical Center
  Boston, Massachusetts, United States Not yet recruiting
• Henry Ford Health
  Novi, Michigan, United States Not yet recruiting

Study contacts

• Study coordinator: Roger Canton
• Email: rcanton@deepull.com
• Phone: 936553530

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• New care guideline for infants 60 days and younger with fever in Sweden

  This project will test a new guideline to see if infants 60 days or younger with fever can safely avoid many invasive tests, hospital stays, and broad antibiotics compared with usual care.

  Recruiting at 9 sites Region Skane · Gothenburg and 10 other locations · NCT07134751

• Improving vancomycin dosing for young infants with infections

  This study is testing a new way to give the right amount of vancomycin to young infants with infections to help them get better faster.

  Recruiting at 2 sites Phase 4 Murdoch Childrens Research Institute · Melbourne, Victoria and 3 other locations · NCT05770622

• Using fosfomycin to treat severely infected patients

  This study is testing if an intravenous antibiotic called fosfomycin can safely help people with serious infections like osteomyelitis and bacterial meningitis feel better.

  Recruiting at 45 sites Infectopharm Arzneimittel GmbH · Hall in Tirol and 49 other locations · NCT02979951

• Pneumococcal infection surveillance in Lebanon

  This study is trying to find out which types of bacteria cause serious infections like pneumonia in Lebanon and how well current vaccines and antibiotics work against them.

  Recruiting American University of Beirut Medical Center · Beirut · NCT00901602

• Ruta C and Vitamin C in Sepsis: Adding antioxidants to standard care

  This trial tests whether adding Ruta C (rutin plus vitamin C) or vitamin C alone to standard sepsis treatment helps adults in the ICU stay shorter and recover better.

  Recruiting Ain Shams University · Cairo, Cairo Governorate · NCT07922213

• Early detection of sepsis-related blood clotting problems in severe burn patients

  This study tests how well the JAAM-2 score can detect sepsis-induced coagulopathy early in adults with severe burns who develop sepsis in the ICU.

  Recruiting Center for Traumatology and Major Burns, Ben Arous · Tunis · NCT07914205

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.