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Active, not recruiting Observational

Multicenter Symphony™ IL-6 Monitoring Sepsis ED Pilot Study

NCT07425587 · tracked via the Priya Life Science USA tracker
Sponsor
Bluejay Diagnostics, Inc
Phase
Observational
Started
2026-05-04
Last updated
2026-09-29

Condition(s) studied

Sepsis, Septic Shock

Study summary

The primary objective of this study is to establish an IL-6 concentration cutoff that predicts sepsis or septic shock (according to the Third International Consensus Definitions (Sepsis-3 criteria)) in patients who are admitted or are intended to be admitted to the hospital from the emergency department with suspected infection.

Eligibility

Sex
ALL
Min age
22 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adult patients (≥22 years of age) * Intent to admit to hospital or admitted to the hospital via the emergency department * At least 0.6 mL plasma drawn (optimal 1 mL) and available for collection (or is anticipated to be able to be drawn and available) within 12 hours of (i.e., up to 12 hours after) presentation to the emergency department. For Cohort 1, Criterion #1 criteria should be met within 3 hours of sample collection (fresh or remnant). * Meets criteria for at least one of the 3 cohorts (patients may be included in more than one cohort) within 12 hours of emergency department presentation: 1\. Cohort 1 (Systemic inflammatory response or culture ordered): * Criterion #1 (2 of below within 3 hours of sample collection, of which 1 is at least (A) or (B)) * A) body temperature \>38C or \<36C, * B) HR\>90 beats/min, * C) respiratory rate \>20 breaths/min, or * D) white blood cell count \> 12K or \<4K/microliters or over 10% immature forms or bands) OR: * Criterion #2 (order for culture of a body fluid (e.g., blood, urine, sputum)) 2\. Cohort 2 (Treatment for suspected infection initiated): * Meets criteria for Cohort 1 and antimicrobials (antibiotics or antivirals) ordered. 3\. Cohort 3 (Confirmed or strong evidence of infection): * Meets criteria for Cohorts 1 and 2, AND 1 or more of the following criteria: * Temp \>101F (38.3C) * pneumonia by x-ray or CT, * Urinalysis with WBC\>10/HPF; * Intraabdominal-pelvis infection by CT, U/S, or MRI * Skin / soft tissue infection by clinical exam * Evidence of meningitis on LP; * Positive microbiological culture (cultures drawn within 3 days of presentation) * Suspected line infection (e.g. redness or pus around the line) Exclusion Criteria: * Prisoners or imprisonment at time of enrollment * Pregnant * Prior enrollment into this study * Informed consent as approved by IRB is unable to be obtained. * Environmental exposure (e.g., heat exposure)

Primary outcome measure(s)

  • Sepsis (according to the Third International Consensus Definitions (Sepsis-3 criteria)) within 3 days after inclusion. — Within 3 days after inclusion

Trial sites (5)

FacilityCityRegionStatus
University of Florida College of Medicine Gainesville Florida
Beth Israel Deaconess Medical Center Boston Massachusetts
Wake Forest School of Medicine Winston-Salem North Carolina
Vanderbilt University Medical Center Nashville Tennessee
Intermountain Health Salt Lake City Utah

More Bluejay Diagnostics, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07425587 on ClinicalTrials.gov ↗ ← All trials in the USA