CPCCRN is pleased to announce our newest study, the Personalized Immunomodulation in Pediatric Sepsis-Induced MODS Trial, or PRECISE. The PRECISE Trial, funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, will begin enrolling in May 2022. All 24 CPCCRN sites will participate in enrolling for this study. For more information about the study, please read the overview below, or view our registrations on clinicaltrials.gov (NCT05266001, NCT05267821)
Personalized Immunomodulation in Pediatric Sepsis-Induced MODS (PRECISE)
The purpose of this study is to improve outcomes in children with sepsis-induced multi-organ dysfunction syndrome (MODS). This will be done by bringing the immune system back to a normal state which assists with infection clearing, improves surveillance for new infection, and promotes tissue healing – all of which we hope will speed the resolution of organ failure.
PRECISE is a prospective, double-blind, randomized controlled trial. Dependent on blood test results that measure immune function (phenotyping) at baseline, the participant will be placed in one of the following 3 groups.
The objective of the GRACE-2 trial is to demonstrate reduced duration/severity of organ dysfunction and death in children with sepsis-induced MODS. Participants, whose blood test results show immunoparalysis with mild to moderate inflammation, will be assigned to receive either GM-CSF or placebo (saline). GM-CSF is used to target stimulation of the immune system by increasing the white blood cell production. Secondary objectives include understanding the impact of GM-CSF treatment on short-term health-related quality of life and functional status.
The objective of the TRIPS trial is to demonstrate reduced duration/severity of organ dysfunction and death in children with sepsis-induced MODS for participants whose blood test results show either no immunoparalysis with moderate to severe inflammation or immunoparalysis with severe inflammation. Participants qualifying for this cohort will be given the targeted anti-inflammatory therapy anakinra or placebo (saline). Secondary objectives include understanding the impact of anakinra treatment on short-term health-related quality of life and functional status.
Participants who do not qualify for GRACE-2 or TRIPS based on their blood test results will be enrolled into the observational cohort. The observational cohort will have the same study procedures completed, with the exception of study drug administration. The observational cohort consists of two sets of participants, those whose blood test shows either no immunoparalysis with mild inflammation or no immunoparalysis with severe inflammation. Those with no immunoparalysis and mild inflammation are expected to have a good outcome, while those with no immunoparalysis and severe inflammation should be treated with medication and not be given placebo.
The PRECISE Trial is projected to be complete in the Spring of 2026.