Multicenter Symphony IL-6 Monitoring Sepsis ICU Validation Study (SYMON II)

The primary objective of this study is to validate a pre-defined IL-6 concentration cutoff that predicts 28-day mortality in patients who are admitted or are intended to be admitted to the ICU diagnosed with sepsis or septic shock.

Study Overview

• Status: Recruiting
• Conditions: Sepsis, Septic Shock

• Study Type: Observational
• Enrollment (Estimated): 700

Contacts and Locations

• Study Contact: Name: Clinical Affairs; Phone Number: 844-327-7078; Email: clinical@bluejaydx.com

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • Recruiting
      • University of Florida College of Medicine
      • Contact: Office of Research College of Medicine; Phone Number: 352-273-5946; Email: com-research@ufl.edu
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Beth Israel Deaconess Medical Center
      • Contact: Clinical Affairs
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest School of Medicine
      • Contact: Clinical Translation Science Institute; Phone Number: 336-716-1195; Email: ctsi@wakehealth.edu
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Recruiting
      • Vanderbilt University Medical Center
      • Contact: VUMC Office of Research; Phone Number: 615-322-5000; Email: sponsoredprograms@vumc.org
  • Utah
    • Salt Lake City, Utah, United States, 84111
      • Recruiting
      • Intermountain Health
      • Contact: Clinical Affairs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult patients diagnosed with sepsis or septic shock, in accordance with the sepsis-3 criteria, admitted or intended to be admitted to the ICU.

Description

Inclusion Criteria:

• Adult patients (≥22 years of age)

• Diagnosis of sepsis or septic shock based on: the Third International Consensus Definitions (Sepsis-3 criteria) defined as at least one of the following criteria as determined by a treating physician or study physician investigator.

  • Sepsis: suspected or documented infection (i.e., use or intent to use antibiotics as an indicator) and organ dysfunction defined by a Sequential Organ Failure Assessment (SOFA) score ≥2
  • Septic shock: sepsis requiring vasopressors and serum lactate levels >2 mmol/L (18 mg/dL)
• Admitted or intended to be admitted to the ICU
• At least 3 mL plasma drawn and available for collection (or is anticipated to be able to be drawn and available) within 24 hours of (i.e., up to 24 hours after) the earliest diagnosis of sepsis or septic shock.

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28-day all-cause mortality [Time Frame: within 28 days after inclusion] participants will be followed up for 28 days	Participants will be followed up for 28 days for all-cause mortality	Within 28 days after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-hospital mortality up to 28 days	Participants will be followed up for 28 days for in-hospital mortality	Within 28 days after inclusion
All-cause mortality up to 7 days	Participants will be followed up for 7 days for all-cause mortality	Within 7 days after inclusion
Sequential Organ Failure Assessment (SOFA) score	SOFA score has a range from 1 to 24, where higher scores represent higher degrees of single or multiple organ failure(s).	Within 28 days after inclusion
Hospital length of stay	Participants will be followed up for hospital length of stay for up to 28 days	Within 28 days after inclusion
ICU length of stay	Participants will be followed up for ICU length of stay for up to 28 days	Within 28 days after inclusion
Vasopressor utilization	Participants will be followed up for use of Vasopressors for up to 28 days	Within 28 days after inclusion
Progression to septic shock	Participants will be followed up for progression to septic shock for up to 28 days	Within 28 days after inclusion
28-day all-cause mortality in patients with a final diagnosis of sepsis or septic shock	Participants will be followed up for 28 days for all-cause mortality	Within 28 days after inclusion

Collaborators and Investigators

• Sponsor: Bluejay Diagnostics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2024
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: October 15, 2024
• First Submitted That Met QC Criteria: October 21, 2024
• First Posted (Actual): October 23, 2024

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Inflammation; Pathologic Processes; Shock; Septic Shock; Sepsis; Risk Stratification; Infections; IL-6; Systemic Inflammatory Response Syndrome; Interleukin-6; Toxima
• Additional Relevant MeSH Terms: Pathological Conditions, Signs and Symptoms; Inflammation; Sepsis; Infections; Pathologic Processes; Shock; Shock, Septic; Systemic Inflammatory Response Syndrome
• Other Study ID Numbers: CES-0008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No