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.