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Can a drug reverse immune shutdown in kids with sepsis?

NCT ID NCT05266001

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a drug called GM-CSF in 141 children with sepsis who had multiple organ failure and a weakened immune system. The goal was to see if the drug could help their organs recover better than a placebo. The trial is complete, and results will show if this approach improves survival and quality of life.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

141 people

The number who actually took part.

Started

Jun 2022

Finished

Sep 2025

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 * History of myeloid leukemia, myelodysplasia, or autoimmune thrombocytopenia; 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 GM-CSF; OR * Known pregnancy; OR * Lactating females; OR * Receipt of anakinra or GM-CSF within the previous 28 days; OR * Resolution of MODS by MODS Day 2; OR * Previous enrollment in the GRACE-2 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

Contacts and locations

Locations

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72202, United States

  • Benioff Children's Hospital - Mission Bay

    San Francisco, California, 94143, United States

  • Benioff Children's Hospital - Oakland

    Oakland, California, 64609, United States

  • CS Mott Children's Hospital

    Ann Arbor, Michigan, 48109, United States

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Children's Hospital of Los Angeles

    Los Angeles, California, 90027, United States

  • Children's Hospital of Michigan

    Detroit, Michigan, 48202, United States

  • Children's Hospital of Minnesota

    Minneapolis, Minnesota, 55404, United States

  • Children's Hospital of Orange County

    Orange, California, 92868, United States

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15260, United States

  • Children's Hospital of San Antonio

    San Antonio, Texas, 78207, United States

  • Children's National Medical Center

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

  • Duke University

    Durham, North Carolina, 27705, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53233, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Mercy Children's Hospital

    Kansas City, Missouri, 64108, United States

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

  • Pennsylvania State University

    Hershey, Pennsylvania, 17033, United States

  • Primary Children's Hospital

    Salt Lake City, Utah, 84158, United States

  • Rainbow Babies and Children's Hospital

    Cleveland, Ohio, 44106, United States

  • Texas Children's Hospital

    Houston, Texas, 77030, United States

  • University of California - Davis

    Sacramento, California, 95618, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • Virginia Commonwealth University

    Richmond, Virginia, 23298, United States

More trials for these conditions

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