NCT07425587 · Bluejay Diagnostics, Inc.
Multicenter Symphony™ IL-6 Monitoring Sepsis ED Pilot Study
(SYMON III)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Prior enrollment into this study
- Informed consent as approved by IRB is unable to be obtained.
- Environmental exposure (e.g., heat exposure)
Where
- Gainesville, Florida
- Boston, Massachusetts
- Winston-Salem, North Carolina
- Nashville, Tennessee
- Salt Lake City, Utah
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 2, 2026 · Source of record for eligibility and locations