Multicenter Symphony™ IL-6 Monitoring Sepsis ED Pilot Study

Recruiting now

Conditions studied: Sepsis, Septic Shock

In brief

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.

Key facts

Study ID

NCT07425587

Run by

Bluejay Diagnostics, Inc.

People needed

450

Starts

2026-05-04

Expected to finish

2026-12-30

Last updated by the study team

2026-07-02

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• 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))
• Cohort 2 (Treatment for suspected infection initiated):
• Meets criteria for Cohort 1 and antimicrobials (antibiotics or antivirals) ordered.
• 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)

You may not qualify if…

• 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)

Where it is running

• University of Florida College of Medicine — Gainesville, Florida, United States (enrolling)
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
• Wake Forest School of Medicine — Winston-Salem, North Carolina, United States (enrolling)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
• Intermountain Health — Salt Lake City, Utah, United States (enrolling)

Full record on ClinicalTrials.gov

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