NCT05266001

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 141 (actual)
• Sponsor: Nationwide Children's Hospital · Academic / Other
• Sex: All
• Age: 1 Day – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The GRACE-2 study is a 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. Eligible subjects will undergo centralized immunophenotyping on MODS Day 2. Those who are found to have immunoparalysis (a whole blood LPS-induced TNF-alpha production capacity \< 200 pg/ml) with mild to moderate inflammation (serum ferritin level \< 2000 ng/ml) will be randomized to receive intravenous (IV) GM-CSF at a dose of 125 mcg/m2/day x 7 days or placebo. The primary outcome variable is the cumulative 28-day Pediatric Logistic Organ Dysfunction (PELOD)-2 score. Secondary outcomes include measures of health-related quality of life and function status at 3 months from randomization.

Conditions

• Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome

Interventions

Type	Name	Description
DRUG	GM-CSF	same as arm/group description
OTHER	Placebo	same as arm/group description

Timeline

• Start date: 2022-06-14
• Primary completion: 2025-09-10
• Completion: 2025-09-10
• First posted: 2022-03-04
• Last updated: 2026-04-09

Locations

25 sites across 1 country: United States

Regulatory

• FDA-regulated drug study