Overview

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

Status:
Not yet recruiting
Trial end date:
2027-08-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Nationwide Children's Hospital
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Criteria
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.