Summary

Eligibility
for people ages up to 17 years (full criteria)
Location
at Oakland, California and other locations
Dates
study started
estimated completion

Description

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).

Official Title

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

Details

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.

Keywords

Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome (MODS), Sepsis, Toxemia, Inflammation, Multiple Organ Failure, Interleukin 1 Receptor Antagonist Protein, Anakinra, Anakinra 4 mg/kg/day, Anakinra 8 mg/kg/day, Anakinra 12 mg/kg/day, Anakinra 16 mg/kg/day

Eligibility

You can join if…

Open to people ages up to 17 years

  • ≥ 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.

You CAN'T join if...

  • 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
  • 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 therapyOR 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 or GM-CSF within the previous 28 days; OR
  • Resolution of MODS by MODS Day 2; OR
  • Previous enrollment in the TRIPS study.

Locations

  • Benioff Children's Hospital - Oakland not yet accepting patients
    Oakland California 64609 United States
  • Benioff Children's Hospital - Mission Bay not yet accepting patients
    San Francisco California 94143 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Nationwide Children's Hospital
ID
NCT05267821
Phase
Phase 2/3 Multiple Organ Dysfunction Syndrome Research Study
Study Type
Interventional
Participants
Expecting 500 study participants
Last Updated