GM-CSF for Reversal of Immunoparalysis in Pediatric Sepsis-induced MODS
GRACE-2
1 other identifier
interventional
141
1 country
25
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 have immunoparalysis with mild to moderate inflammation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2022
Typical duration for phase_3
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2022
CompletedFirst Posted
Study publicly available on registry
March 4, 2022
CompletedStudy Start
First participant enrolled
June 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 10, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 10, 2025
CompletedApril 9, 2026
April 1, 2026
3.2 years
February 23, 2022
April 8, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Cumulative 28-day Pediatric Logistic Organ Dysfunction (PELOD)-2 score
Cumulative Pediatric Logistic Organ Dysfunction (PELOD)-2 score through 28 days post-randomization. The range of PELOD-2 score for a given day is 0 - 33 with a higher number being worse.
28 days from randomization
Secondary Outcomes (2)
3-month health-related quality of life
3 months post-randomization
3-month functional status
3 months post-randomization
Study Arms (2)
GM-CSF
ACTIVE COMPARATORIntravenous GM-CSF 125 mcg/m2/day x 7 days
Placebo
PLACEBO COMPARATORIntravenous placebo x 7 days
Interventions
Eligibility Criteria
You may qualify if:
- ≥ 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
Children's Hospital of Los Angeles
Los Angeles, California, 90027, United States
Benioff Children's Hospital - Oakland
Oakland, California, 64609, United States
Children's Hospital of Orange County
Orange, California, 92868, United States
University of California - Davis
Sacramento, California, 95618, United States
Benioff Children's Hospital - Mission Bay
San Francisco, California, 94143, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
CS Mott Children's Hospital
Ann Arbor, Michigan, 48109, United States
Children's Hospital of Michigan
Detroit, Michigan, 48202, United States
Children's Hospital of Minnesota
Minneapolis, Minnesota, 55404, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Mercy Children's Hospital
Kansas City, Missouri, 64108, United States
Duke University
Durham, North Carolina, 27705, United States
Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Pennsylvania State University
Hershey, Pennsylvania, 17033, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15260, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
Children's Hospital of San Antonio
San Antonio, Texas, 78207, United States
Primary Children's Hospital
Salt Lake City, Utah, 84158, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53233, United States
Related Publications (1)
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.
PMID: 37498156DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief, Critical Care Medicine
Study Record Dates
First Submitted
February 23, 2022
First Posted
March 4, 2022
Study Start
June 14, 2022
Primary Completion
September 10, 2025
Study Completion
September 10, 2025
Last Updated
April 9, 2026
Record last verified: 2026-04