New blood test aims to predict sepsis in minutes, not hours
NCT ID NCT07425587
First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 1 time
Summary
This study tests whether measuring a substance called IL-6 in the blood can quickly predict if an emergency room patient with a suspected infection will develop sepsis or septic shock. Researchers will enroll 450 adults admitted from the ER and track their outcomes for up to 30 days. The goal is to find a cutoff level of IL-6 that reliably identifies those at highest risk, enabling faster, more targeted care.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- IL-6 blood test
- What this could lead to
- If successful, this could provide a rapid, reliable way to identify sepsis early in the emergency room, potentially saving lives by speeding up treatment.
- What could go wrong
- This is an early pilot study, so the test may not prove accurate enough. It also only measures one marker, which might miss some cases of sepsis.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 450 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Adult patients who are admitted or are intended to be admitted to the hospital from the emergency department with suspected infection.
- Ages
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22 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Locations
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Beth Israel Deaconess Medical Center
RECRUITINGBoston, Massachusetts, 02215, United States
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Intermountain Health
RECRUITINGSalt Lake City, Utah, 84111, United States
Contact Email: •••••@•••••
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University of Florida College of Medicine
RECRUITINGGainesville, Florida, 32610, United States
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Vanderbilt University Medical Center
RECRUITINGNashville, Tennessee, 37232, United States
Contact Email: •••••@•••••
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Wake Forest School of Medicine
RECRUITINGWinston-Salem, North Carolina, 27157, United States
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