Multicenter Symphony™ IL-6 Monitoring Sepsis ED Pilot Study (SYMON III)

February 13, 2026 updated by: Bluejay Diagnostics, Inc.
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Sepsis (according to the Third International Consensus Definitions (Sepsis-3 criteria)) within 3 days after inclusion.
Time Frame: Within 3 days after inclusion
Within 3 days after inclusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
In-hospital mortality up to 30 days
Time Frame: Within 30 days after inclusion
Within 30 days after inclusion
In-hospital mortality up to 7 days
Time Frame: Within 7 days after inclusion
Within 7 days after inclusion
Sequential Organ Failure Assessment (SOFA) score
Time Frame: Within 3 days after inclusion
SOFA score has a range of 1 to 24, where higher scores represent higher degrees of single or multiple organ failure(s)
Within 3 days after inclusion
Hospital Length of Stay
Time Frame: Participants will be followed up for hospital length of stay for up to 30 days
Participants will be followed up for hospital length of stay for up to 30 days
ICU length of stay
Time Frame: Within 30 days after inclusion
Within 30 days after inclusion
Bacterial vs viral infection (As assessed by cultures and/or viral testing)
Time Frame: Within 30 days after inclusion
As assessed by cultures and/or viral testing.
Within 30 days after inclusion
Progression to septic shock
Time Frame: Within 30 days after inclusion
Participants will be followed up for progression to septic shock for up to 30 days
Within 30 days after inclusion
30-day all-cause mortality in patients with a final diagnosis of sepsis or septic shock
Time Frame: Within 30 days after inclusion
Participants will be followed up for 30 days for all-cause mortality
Within 30 days after inclusion
Initiation of vasopressor therapy (by hospital discharge or up to 30 days)
Time Frame: within 30 days after inclusion
within 30 days after inclusion
Initiation of renal replacement therapy (by hospital discharge or up to 30 days)
Time Frame: Within 30 days after inclusion
Within 30 days after inclusion
Initiation of mechanical ventilation (by hospital discharge or up to 30 days)
Time Frame: Within 30 days after inclusion
Within 30 days after inclusion
Free days from vasopressor therapy (by hospital discharge or up to 30 days)
Time Frame: Within 30 days after inclusion
Within 30 days after inclusion
Free days from renal replacement therapy (by hospital discharge or up to 30 days)
Time Frame: Within 30 days after inclusion
Within 30 days after inclusion
Free days from mechanical ventilation (by hospital discharge or up to 30 days)
Time Frame: Within 30 days after inclusion
Within 30 days after inclusion
Free days from vasopressor therapy, renal replacement therapy, or mechanical ventilation, (by hospital discharge or up to 30 days)
Time Frame: Within 30 days after inclusion
Within 30 days after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bluejay Diagnostics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 12, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CES-0009

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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