GM-CSF for Reversal of Immunoparalysis in Pediatric Sepsis-induced MODS

Completed · Phase 3 · Has a placebo group

Conditions studied: Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome

In brief

The GRACE-2 study is a prospective, multi-center, double-blind, randomized controlled trial of the drug GM-CSF vs placebo in children with sepsis-induced multiple organ dysfunction syndrome (MODS) who have immunoparalysis with mild to moderate inflammation.

Key facts

Study ID

NCT05266001

Run by

Nationwide Children's Hospital

People needed

141

Starts

2022-06-14

Expected to finish

2025-09-10

Last updated by the study team

2026-04-09

Who can join

Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 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.

You may not qualify if…

• 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.

Where it is running

• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• Children's Hospital of Los Angeles — Los Angeles, California, United States
• Benioff Children's Hospital - Oakland — Oakland, California, United States
• Children's Hospital of Orange County — Orange, California, United States
• University of California - Davis — Sacramento, California, United States
• Benioff Children's Hospital - Mission Bay — San Francisco, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• CS Mott Children's Hospital — Ann Arbor, Michigan, United States
• Children's Hospital of Michigan — Detroit, Michigan, United States
• Children's Hospital of Minnesota — Minneapolis, Minnesota, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Mercy Children's Hospital — Kansas City, Missouri, United States
• Duke University — Durham, North Carolina, United States
• Rainbow Babies and Children's Hospital — Cleveland, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Pennsylvania State University — Hershey, Pennsylvania, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Texas Children's Hospital — Houston, Texas, United States
• Children's Hospital of San Antonio — San Antonio, Texas, United States
• Primary Children's Hospital — Salt Lake City, Utah, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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