Sepsis, Septic ShockSYMON IIINCT07425587
Multicenter Symphony™ IL-6 Monitoring Sepsis ED Pilot Study
An observational study of Sepsis, Septic Shock, run by Bluejay Diagnostics, Inc. at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Sepsis, Septic Shock
- How many people
- 450 participants
- Where
- 5 sitesUnited States
- Study dates
- 4 May 2026to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients who are admitted or are intended to be admitted to the hospital from the emergency department with suspected infection.
Who may be able to join
- 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))
Show all 23Show fewer
- 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)
Who cannot join
- 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)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University of Florida College of Medicine
Gainesville, Florida, 32610
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Intermountain Health
Salt Lake City, Utah, 84111
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157
About this study
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
- Medical subject headings
- Sepsis, Shock, Septic, Infections, Systemic Inflammatory Response Syndrome, Inflammation, Shock, Pathologic Processes, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Sepsis (according to the Third International Consensus Definitions (Sepsis-3 criteria)) within 3 days after inclusion.
Measured: Within 3 days after inclusion
Secondary outcomes (15)
In-hospital mortality up to 30 days
Measured: Within 30 days after inclusion
In-hospital mortality up to 7 days
Measured: Within 7 days after inclusion
Sequential Organ Failure Assessment (SOFA) score
SOFA score has a range of 1 to 24, where higher scores represent higher degrees of single or multiple organ failure(s)
Measured: Within 3 days after inclusion
Hospital Length of Stay
Measured: Participants will be followed up for hospital length of stay for up to 30 days
ICU length of stay
Measured: Within 30 days after inclusion
Bacterial vs viral infection (As assessed by cultures and/or viral testing)
As assessed by cultures and/or viral testing.
Measured: Within 30 days after inclusion
Progression to septic shock
Participants will be followed up for progression to septic shock for up to 30 days
Measured: Within 30 days after inclusion
30-day all-cause mortality in patients with a final diagnosis of sepsis or septic shock
Participants will be followed up for 30 days for all-cause mortality
Measured: Within 30 days after inclusion
Initiation of vasopressor therapy (by hospital discharge or up to 30 days)
Measured: within 30 days after inclusion
Initiation of renal replacement therapy (by hospital discharge or up to 30 days)
Measured: Within 30 days after inclusion
Initiation of mechanical ventilation (by hospital discharge or up to 30 days)
Measured: Within 30 days after inclusion
Free days from vasopressor therapy (by hospital discharge or up to 30 days)
Measured: Within 30 days after inclusion
Free days from renal replacement therapy (by hospital discharge or up to 30 days)
Measured: Within 30 days after inclusion
Free days from mechanical ventilation (by hospital discharge or up to 30 days)
Measured: Within 30 days after inclusion
Free days from vasopressor therapy, renal replacement therapy, or mechanical ventilation, (by hospital discharge or up to 30 days)
Measured: Within 30 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start4 May 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sepsis, Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bluejay Diagnostics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shapiro, Principal investigator, Beth Israel Deaconess Medical CenterPeltan, Principal investigator, Intermountain HealthMarchick, Principal investigator, University of FloridaWare, Principal investigator, Vanderbilt University Medical CenterMahler, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07425587
- Sponsor's protocol ID
- CES-0009
- Acronym
- SYMON III
- Status last verified
- Sep 2026
- First submitted
- 2 Feb 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Symphony™ IL-6 Monitoring Sepsis ED Pilot Study
- ClinicalTrials.gov ID
- NCT07425587
- Acronym / sponsor ID
- SYMON III / CES-0009
- Conditions
- Sepsis, Septic Shock
- Keywords
- Interleukin-6, IL-6, Risk Stratification, Infections, Toxima, Systemic Inflammatory Response Syndrome, Inflammation, Sepsis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Bluejay Diagnostics, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 May 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who are admitted or are intended to be admitted to the hospital from the emergency department with suspected infection.
Key inclusion criteria (23 listed)
- 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:
- Criterion #1 (2 of below within 3 hours of sample collection, of which 1 is at least (A) or (B))
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sepsis (according to the Third International Consensus Definitions (Sepsis-3 criteria)) within 3 days after inclusion.
Time frame: Within 3 days after inclusion
15 secondary outcomes
In-hospital mortality up to 30 days
Time frame: Within 30 days after inclusion
In-hospital mortality up to 7 days
Time frame: Within 7 days after inclusion
Sequential Organ Failure Assessment (SOFA) score
Time frame: 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
ICU length of stay
Time frame: Within 30 days after inclusion
Bacterial vs viral infection (As assessed by cultures and/or viral testing)
Time frame: Within 30 days after inclusion
Progression to septic shock
Time frame: 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
Initiation of vasopressor therapy (by hospital discharge or up to 30 days)
Time frame: 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
Initiation of mechanical ventilation (by hospital discharge or up to 30 days)
Time frame: 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
Free days from renal replacement therapy (by hospital discharge or up to 30 days)
Time frame: 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Sepsis, Septic Shock
RecruitingPhase 3
Systematic Adjunction of Vasopressine in Septic Shock
Septic Shock
Not yet recruitingObservational study
Clinical Value of EMR3 in Sepsis Diagnosis, Monitoring, and Prognosis: A Multicenter Prospective Observational Study
Sepsis
Not yet recruitingObservational study
Neutrophil Activation and NETosis in Sepsis
Sepsis, Septic Shock
Recruiting
Efficacy and Safety of Methylene Blue in the Treatment of Severe Septic Shock
Septic Shock, Methylene Blue
Not yet recruiting
Perfusion Efficiency-Guided MAP De-escalation in Elderly Septic Shock
Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shapiro principal investigator
Beth Israel Deaconess Medical Center
Peltan principal investigator
Intermountain Health
Marchick principal investigator
University of Florida
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, Septic Shock, run by Bluejay Diagnostics, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.