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New blood test aims to predict sepsis in minutes, not hours

NCT ID NCT07425587

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

About 450 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

22 years and older

Sex

Anyone

Healthy volunteers

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

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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Conditions

The condition(s) this trial relates to.

Emergencies Infections infectious disease with sepsis Inflammation Pathologic Processes Sepsis Shock Systemic Inflammatory Response Syndrome toxic shock syndrome

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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    5 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Locations

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Intermountain Health

    RECRUITING

    Salt Lake City, Utah, 84111, United States

    Contact Email: •••••@•••••

  • University of Florida College of Medicine

    RECRUITING

    Gainesville, Florida, 32610, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

    Contact Email: •••••@•••••

  • Wake Forest School of Medicine

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.