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

Phase 3 Completed 141 enrolled Nationwide Children's Hospital Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collab

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2022-06-14
Primary completion: 2025-09-10
Completion: 2025-09-10

Publications

VanBuren JM, Hall M, Zuppa AF, Mourani PM, Carcillo J, Dean JM, Watt K, Holubkov R. The Design of Nested Adaptive Clinical Trials of Multiple Organ Dysfunction Syndrome Children in a Single Study. Pediatr Crit Care Med. 2023 Dec 1;24(12):e635-e646. doi: 10.1097/PCC.0000000000003332. Epub 2023 Jul 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	sargramostim	Protein / enzyme biologic	125 ug/m2	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications