Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS
a study on Multiple Organ Dysfunction Syndrome Sepsis
Summary
- Eligibility
- for people ages up to 17 years (full criteria)
- Location
- at UC Davis UCSF
- Dates
- study startedcompletion around
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
accepting new patients
Oakland California 64609 United States - University of California, Davis
accepting new patients
Sacremento California 95817 United States - Benioff Children's Hospital - Mission Bay
accepting new patients
San Francisco California 94143 United States - Children's Hospital of Los Angeles
accepting new patients
Los Angeles California 90027 United States - Children's Hospital of Orange County
not yet accepting patients
Orange California 92868 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Nationwide Children's Hospital
- ID
- NCT05267821
- Phase
- Phase 2/3 research study
- Study Type
- Interventional
- Participants
- Expecting 500 study participants
- Last Updated