PeRsonalizEd immunomodulation in pediatriC sepsIS-inducEd MODS (PRECISE) Study

Protocol Description

This is a large-scale multi-center study of personalized, targeted immune modulation in children with sepsis-induced multiple organ dysfunction syndrome (MODS) in the PICU. The study includes two concurrent, immunophenotype-driven placebo controlled RCTs that will address the central hypothesis that individualized, pathophysiology-specific immunomodulation will improve outcomes from sepsis-induced MODS in children. Children’s Hospital of Pittsburgh of UPMC is part of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)'s Collaborative Pediatric Critical Care Research Network (CPCCRN) involving 26 U.S. hospitals and up to 1000 child participants.

Eligibility Criteria

Critically ill children admitted to the PICU from newborn age up to 17 years may take part in this research study if they meet eligibility requirements. Among those requirements, participants must have sepsis-induced MODS.
Boys: Newborn to 17 years
Girls: Newborn to 17 years

Requirements

While in the PICU, children will be tested for immune phenotypes which determines whether the child will receive a test intervention or placebo or no intervention.
Visits: Occurs during hospitalization
Duration: Up to 1 year

Status: Open for Enrollment expected Summer 2022

Source(s) of Support

National Institute of Child Health and Human Development

Additional Information

Study Description at National Institutes of Health (GRACE-2)
Study Description at National Institutes of Health (TRIPS)

Primary Investigator

Joseph A. Carcillo, MD (Site Primary Investigator)
Ericka L. Fink, MD (Site Co-Investigator)