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Could a simple drug save kids from sepsis organ failure?

NCT ID NCT05267821

Disease control Sponsor: Nationwide Children's Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether anakinra, a drug that blocks inflammation, can help children with sepsis who are experiencing multiple organ failure. The trial will involve 500 children in intensive care, comparing anakinra to a placebo. The goal is to see if the drug can reduce organ damage and improve quality of life after recovery.

What this could mean

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

Active substance
Anakinra (a drug that blocks inflammation)
What this could lead to
If successful, this could provide a new treatment to reduce organ damage and improve survival in children with severe sepsis.
What could go wrong
This is a mid-stage trial, so results are not guaranteed. Anakinra may not work better than placebo, and could have side effects like increased infection risk.

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.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 500 people

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

Started

Jun 2022

Expected to finish

Aug 2028

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.

Ages

1 day to 17 years

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: * ≥ 40 weeks corrected gestational age to \< 18 years; AND * Admission to the PICU or CICU; AND * Onset of ≥ 2 new organ dysfunctions within the last 3 calendar days (compared to pre-sepsis baseline) as measured by the modified Proulx criteria; AND * Documented or suspected infection as the MODS inciting event. Exclusion Criteria: * Weight \<3kg; OR * Limitation of care order at the time of screening; OR * Patients at high likelihood of progression to brain death in opinion of the clinical team; OR * Moribund condition in which the patient is unlikely to survive the next 48 hours in opinion of the clinical team; OR * Current or prior diagnosis of hemophagocytic lymphohistiocytosis or macrophage activation syndrome; OR * Peripheral white blood cell count \< 1,000 cells/mm3 as the result of myeloablative therapy OR receipt of myeloablative therapy within the previous 14 days; OR * Known allergy to anakinra, or E. coli-derived products; OR * Known pregnancy; OR * Lactating females; OR * Receipt of anakinra within the previous 28 days; OR * Resolution of MODS by MODS Day 2; OR * Previous enrollment in the TRIPS study.

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Conditions

The condition(s) this trial relates to.

multiple organ dysfunction syndrome

As listed by the trial registrant

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

Pediatric sepsis-induced multiple organ dysfunction syndrome (MODS)

How to take part

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

  1. The places running it

    32 sites. 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

  • Akron Children's Hospital

    RECRUITING

    Akron, Ohio, 44308, United States

  • Arkansas Children's Hospital

    RECRUITING

    Little Rock, Arkansas, 72202, United States

  • Benioff Children's Hospital - Mission Bay

    RECRUITING

    San Francisco, California, 94143, United States

  • Benioff Children's Hospital - Oakland

    RECRUITING

    Oakland, California, 64609, United States

  • CS Mott Children's Hospital

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • Children's Hospital Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Children's Hospital of Atlanta

    RECRUITING

    Atlanta, Georgia, 30329, United States

  • Children's Hospital of Los Angeles

    RECRUITING

    Los Angeles, California, 90027, United States

  • Children's Hospital of Michigan

    RECRUITING

    Detroit, Michigan, 48201, United States

  • Children's Hospital of Minnesota

    NOT_YET_RECRUITING

    Minneapolis, Minnesota, 55404, United States

  • Children's Hospital of Orange County

    NOT_YET_RECRUITING

    Orange, California, 92868, United States

  • Children's Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Children's Hospital of Pittsburgh

    RECRUITING

    Pittsburgh, Pennsylvania, 15260, United States

  • Children's Hospital of San Antonio

    RECRUITING

    San Antonio, Texas, 78207, United States

  • Children's National Medical Center

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Children's of Alabama

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • Cincinnati Children's Hospital Medical Center

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Duke University

    RECRUITING

    Durham, North Carolina, 27705, United States

  • Medical College of Wisconsin

    NOT_YET_RECRUITING

    Milwaukee, Wisconsin, 53233, United States

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Mercy Children's Hospital

    RECRUITING

    Kansas City, Missouri, 64108, United States

  • Nationwide Children's Hospital

    RECRUITING

    Columbus, Ohio, 43205, United States

  • Pennsylvania State University

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • Primary Children's Hospital

    RECRUITING

    Salt Lake City, Utah, 84158, United States

  • Rady Children's Hospital

    RECRUITING

    San Diego, California, 92123, United States

  • Rainbow Babies and Children's Hospital

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • Riley Children's Hospital

    RECRUITING

    Indianapolis, Indiana, 46204, United States

  • Texas Children's Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • University of California, Davis

    RECRUITING

    Sacramento, California, 95817, United States

  • University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • University of Texas Southwestern

    RECRUITING

    Dallas, Texas, 75390, United States

  • Virginia Commonwealth University

    RECRUITING

    Richmond, Virginia, 23298, United States