Multicenter Symphony™ IL-6 Monitoring Sepsis ED Pilot Study

NCT07425587 | Not Yet Recruiting

• 1 other identifier: CES-0009
• Study Type: observational
• Target: 450
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Sepsis, Septic Shock

Keywords

Interleukin-6; IL-6; Risk Stratification; Infections; Toxima; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Septic Shock; Shock; Pathologic Process; Emergency Department

Outcome Measures

Primary Outcomes (1)

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

  Within 3 days after inclusion

Secondary Outcomes (15)

• In-hospital mortality up to 30 days

  Within 30 days after inclusion

• In-hospital mortality up to 7 days

  Within 7 days after inclusion

• Sequential Organ Failure Assessment (SOFA) score

  Within 3 days after inclusion

• Hospital Length of Stay

  Participants will be followed up for hospital length of stay for up to 30 days

• ICU length of stay

  Within 30 days after inclusion

Study Arms (3)

Cohort 1: Systemic inflammatory response or culture ordered

Criterion #1: (2 of the following within 3 hours of sample collection, of which 1 is at least (A or B): A) body temp \>38c or \<36c B) HR \>90bpm C) respiratory rate \>20 breaths/min 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 (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)

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients who are admitted or are intended to be admitted to the hospital from the emergency department with suspected infection.

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:

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)

Sponsors & Collaborators

• Bluejay Diagnostics, Inc.: lead

MeSH Terms

Conditions

Sepsis; Shock, Septic; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Pathologic Processes; Emergencies

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Shapiro

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

• Peltan

  Intermountain Health

  PRINCIPAL INVESTIGATOR

• Guirgis

  University of Florida

  PRINCIPAL INVESTIGATOR

• Ware

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

• Mahler

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Affairs

CONTACT

844-327-7078; clinical@bluejaydx.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 23, 2026
• Study Start: April 12, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share