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Blood markers could spot sepsis risk early

NCT ID NCT02545478

Knowledge-focused Sponsor: Beth Israel Deaconess Medical Center Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study is looking at whether early signs of inflammation in the blood can help identify which patients with infections are at risk for serious complications like sepsis. Researchers will follow 4,200 adults with confirmed or suspected infections, as well as healthy controls, to see how well these biomarkers predict death or organ failure within 28 days. The goal is to improve early detection and treatment of severe infections.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to better tools for early detection of severe infections, helping doctors intervene sooner and potentially reduce deaths from sepsis.
What could go wrong
This is an observational study, not a treatment trial. It may not directly improve patient outcomes, and the biomarkers might not be accurate enough for widespread use.

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 4,200 people

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

Start date

Apr 2006

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients presenting to the Emergency Department with suspected infection as well as a non-infected control population.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 for Infected subjects: * Age 18 years of age or older * Confirmed or suspected infection Inclusion Criteria for Control Subjects: * Age 18 years of age or older * A non-infectious clinical presentation to include * Normal white blood cell count ( \> 4,000 and/or \< 12,000) * Normothermia ( \> 96.5 and/or less 100.4) * Absence of the following clinical complaints: productive cough, fever, pyuria, rash * No evidence of acute coronary syndrome Exclusion Criteria for Control Subjects: \- Suspected infection

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Conditions

The condition(s) this trial relates to.

Infections infectious disease infectious disease with sepsis Inflammation inflammatory disease Pathologic Processes Sepsis toxic shock syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Infection Inflammation Sepsis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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

  • Massachusetts General Hospital

    ACTIVE_NOT_RECRUITING

    Boston, Massachusetts, 02114, United States

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