Multicenter Symphony™ IL-6 Monitoring Sepsis ED Pilot Study

Part of paid clinical trials in Gainesville, Florida.

Sponsor
Bluejay Diagnostics, Inc.
Study ID
NCT07425587
Status
Recruiting
Apply to this trial

Conditions

  • Sepsis, Septic Shock

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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 Dates

Start date
May 4, 2026
Status verified
Jul 2026
Primary completion
Dec 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
450 participants (estimated)

Arms

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

Primary Outcome Measure

Sepsis (according to the Third International Consensus Definitions (Sepsis-3 criteria)) within 3 days after inclusion. [ Time Frame: Within 3 days after inclusion ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
University of Florida College of MedicineGainesvilleFlorida32610
Office of Research, MD
[email protected]
(352) 273-5946
Michael Marchick, MD (PRINCIPAL_INVESTIGATOR)
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Clinical Trials Office
[email protected]
617-667-4443
Nathan I Shapiro, MD (PRINCIPAL_INVESTIGATOR)
Wake Forest School of MedicineWinston-SalemNorth Carolina27157
Clinical Translation Science Institute
[email protected]
336-716-1195
Simon A Mahler, MD (PRINCIPAL_INVESTIGATOR)
Vanderbilt University Medical CenterNashvilleTennessee37232
VUMC Office of Research
[email protected]
6153225000
Lorraine B Ware, MD (PRINCIPAL_INVESTIGATOR)
Intermountain HealthSalt Lake CityUtah84111
Clinical Trials Office
[email protected]
(801) 507-3950
Ithan D Peltan, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Gainesville, FL

By research site
University of Florida College of Medicine· Gainesville, FLBeth Israel Deaconess Medical Center· Boston, MAWake Forest School of Medicine· Winston-Salem, NCVanderbilt University Medical Center· Nashville, TNIntermountain Health· Salt Lake City, UT

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