GM-CSF for Reversal of Immunoparalysis in Pediatric Sepsis-induced MODS
NCT ID: NCT05266001
Last Updated: 2024-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
141 participants
INTERVENTIONAL
2022-06-14
2024-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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GM-CSF
Intravenous GM-CSF 125 mcg/m2/day x 7 days
GM-CSF
same as arm/group description
Placebo
Intravenous placebo x 7 days
Placebo
same as arm/group description
Interventions
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GM-CSF
same as arm/group description
Placebo
same as arm/group description
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
1 Day
17 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Nationwide Children's Hospital
OTHER
Responsible Party
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Mark Hall
Chief, Critical Care Medicine
Locations
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Arkansas Children's Hospital
Little Rock, Arkansas, United States
Children's Hospital of Los Angeles
Los Angeles, California, United States
Benioff Children's Hospital - Oakland
Oakland, California, United States
Children's Hospital of Orange County
Orange, California, United States
University of California - Davis
Sacramento, California, United States
Benioff Children's Hospital - Mission Bay
San Francisco, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
CS Mott Children's Hospital
Ann Arbor, Michigan, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
Children's Hospital of Minnesota
Minneapolis, Minnesota, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mercy Children's Hospital
Kansas City, Missouri, United States
Duke University
Durham, North Carolina, United States
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Pennsylvania State University
Hershey, Pennsylvania, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Texas Children's Hospital
Houston, Texas, United States
Children's Hospital of San Antonio
San Antonio, Texas, United States
Primary Children's Hospital
Salt Lake City, Utah, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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GRACE-2
Identifier Type: -
Identifier Source: org_study_id