NCT05267821

Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS

Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS (TRIPS)

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Nationwide Children's Hospital · Academic / Other
• Sex: All
• Age: 1 Day – 17 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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). Eligible subjects will undergo centralized immunophenotyping on day 2 of MODS. Subjects without immunoparalysis (a whole blood ex vivo LPS-induced TNF-alpha production capacity \< 200 pg/ml) and a serum ferritin level of 500 - 2,000 ng/ml or a serum C-reactive protein (CRP) ≥ 4 mg/dl will be eligible for randomization, along with subjects with a serum ferritin level of 2,000 - 10,000 ng/ml regardless of their TNF-alpha response. Eligible subjects will receive intravenous (IV) anakinra at a dose of 4, 8, 12, or 16 mg/kg/day or placebo for 7 days.

Conditions

• Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome (MODS)

Interventions

Type	Name	Description
DRUG	Anakinra	See information in arm/group descriptions
DRUG	Placebo	See information in arm/group descriptions

Timeline

• Start date: 2022-06-14
• Primary completion: 2028-05-15
• Completion: 2028-08-31
• First posted: 2022-03-04
• Last updated: 2026-03-13

Locations

32 sites across 1 country: United States

Regulatory

• FDA-regulated drug study