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

GRACE-2

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.

2022-06-14

2027-05-31

2027-08-31

Recruiting

Early phase I

400

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.

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2023-02-08