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
    Oakland California 64609 United States
  • Benioff Children's Hospital - Mission Bay
    San Francisco California 94143 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Nationwide Children's Hospital
ID
NCT05267821
Phase
Phase 2/3 Sepsis-induced Multiple Organ Dysfunction Syndrome (MODS) Research Study
Study Type
Interventional
Participants
Expecting 500 study participants
Last Updated