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Can a drug wake up the immune system in kids with sepsis?

NCT ID NCT03769844

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 75 children with sepsis who had a weakened immune system (immunoparalysis) and organ failure. The goal was to see if the drug could restore their immune response and find the best dose and way to give it (by IV or injection). The study focused on measuring immune function, not long-term cure or survival.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

75 people

The number who actually took part.

Started

Dec 2018

Finished

Dec 2023

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

Up 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 gestational age to \<18 years; AND * Onset of \>=2 new organ dysfunctions (compared to pre-sepsis baseline) as measured by the Proulx criteria; AND * Documented or suspected infection as the MODS inciting event. Exclusion Criteria: * Unable to collect a cumulative total of 20.5 mL of blood for this study due to research blood draw limits; OR * Limitation of care order at the time of screening; OR * Patients at high risk for brain death; OR * Active (or planned within 7 days) immunosuppressive treatment for oncologic, transplant, or rheumatologic disease; OR * Known primary immunodeficiency disorder; OR * Diagnosis of myeloid leukemia, myelodysplasia, or autoimmune thrombocytopenia;OR * Known allergy to GM-CSF; OR * Documented hyperferritinemia (serum ferritin \>= 500 ng/ml) during current sepsis event; OR * Contraindication to SQ injection (ECMO); OR * Burns where \>5% of the total body surface area is affected; OR * Renal replacement therapy at the time of screening; OR * On ECMO or anticipated to require ECMO; OR * Known pregnancy; OR * Inability to collect and ship sample for immune testing on MODS Day 2; OR * Previous enrollment in the GRACE study

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Conditions

The condition(s) this trial relates to.

multiple organ dysfunction syndrome Sepsis

As listed by the trial registrant

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

Pediatric sepsis-induced mods

Contacts and locations

Locations

  • Benioff Children's Hospital/UCSF

    San Francisco, California, 94158, United States

  • Children's Hospital of Colorado

    Aurora, Colorado, 80045, United States

  • Children's Hospital of Michigan

    Detroit, Michigan, 48201, United States

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15224, United States

  • Children's National Medical Center

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

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

  • UCLA Mattel Children's Hospital

    Los Angeles, California, 90095, United States