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Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS
RecruitingPhase 2/3
Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS (TRIPS)
Who can join
1 Day – 17 Years · All sexes
Full eligibility criteria
Inclusion Criteria: * ≥ 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 Criteria: * 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 * 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 anakinra, or E. coli-derived products; OR * Known pregnancy; OR * Lactating females; OR * Receipt of anakinra within the previous 28 days; OR * Resolution of MODS by MODS Day 2; OR * Previous enrollment in the TRIPS study.
About the study
The TRIPS study is a prospective, multi-center, double-blind, adaptively randomized, placebo-controlled clinical trial of the drug anakinra for reversal of moderate to severe hyperinflammation in children with sepsis-induced multiple organ dysfunction syndrome (MODS).
What is being tested
- Anakinra (drug)
- Placebo (drug)
Sponsor: Nationwide Children's Hospital · Participants: 500 · Started: Jun 14, 2022
Contact the study team
- Mark Hall, MD · Phone: 6147223438
Official record on ClinicalTrials.gov — NCT05267821
Locations in the U.S.
From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.