Status:
TERMINATED
GM-CSF for Reversal of Immunoparalysis in Pediatric Sepsis-induced MODS
Lead Sponsor:
Nationwide Children's Hospital
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome
Eligibility:
All Genders
1-17 years
Phase:
PHASE3
Brief 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...
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...
Eligibility Criteria
Inclusion
- ≥ 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
- 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.
Key Trial Info
Start Date :
June 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2024
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT05266001
Start Date
June 14 2022
End Date
December 1 2024
Last Update
December 18 2024
Active Locations (25)
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1
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
2
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
3
Benioff Children's Hospital - Oakland
Oakland, California, United States, 64609
4
Children's Hospital of Orange County
Orange, California, United States, 92868