Recruiting

IL-6 Cutoff

Sponsor:

Bluejay Diagnostics, Inc.

Code:

NCT07425587

Conditions

Sepsis, Septic Shock

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT07425587

Start date

May 4, 2026

Status verified date

Jul, 2026

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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
  • Pregnant
  • Prior enrollment into this study
  • Informed consent as approved by IRB is unable to be obtained.
  • Environmental exposure (e.g., heat exposure)

Study Design

Enrollment

450 participants

Anticipated

Interventions and Outcome Measures

Arms

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)

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 and Locations

Central contacts

Clinical Affairs

844-327-7078clinical@bluejaydx.com

Locations

University of Florida College of Medicine

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Office of Research, MD

(352) 273-5946COM-Research@ufl.edu

Principal Investigator:

Michael Marchick, MD

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Clinical Trials Office

617-667-4443cto@bidmc.harvard.edu

Principal Investigator:

Nathan I Shapiro, MD

Wake Forest School of Medicine

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Clinical Translation Science Institute

336-716-1195ctsi@wakehealth.edu

Principal Investigator:

Simon A Mahler, MD

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

VUMC Office of Research

6153225000sponsoredprograms@vumc.org

Principal Investigator:

Lorraine B Ware, MD

Intermountain Health

Recruiting

Salt Lake City, Utah, United States, 84111

Contacts

Clinical Trials Office

(801) 507-3950intermountainresearch@imail.org

Principal Investigator:

Ithan D Peltan, MD

More Information

Sponsor

Bluejay Diagnostics, Inc.

Last update posted

Jul 2, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Bluejay Diagnostics, Inc. on 2026-07-02.