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RECRUITINGPhase 2 / Phase 3INTERVENTIONAL

Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

Who May Be Eligible (Plain English)

Who May Qualify: - ≥ 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Anakinra

See information in arm/group descriptions

DRUG

Placebo

See information in arm/group descriptions

Locations (20)

Children's of Alabama
Birmingham, Alabama, United States
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Children's Hospital of Los Angeles
Los Angeles, California, United States
Benioff Children's Hospital - Oakland
Oakland, California, United States
Children's Hospital of Orange County
Orange, California, United States
University of California, Davis
Sacramento, California, United States
Rady Children's Hospital
San Diego, California, United States
Benioff Children's Hospital - Mission Bay
San Francisco, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Children's Hospital of Atlanta
Atlanta, Georgia, United States
Riley Children's Hospital
Indianapolis, Indiana, United States
CS Mott Children's Hospital
Ann Arbor, Michigan, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
Children's Hospital of Minnesota
Minneapolis, Minnesota, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mercy Children's Hospital
Kansas City, Missouri, United States
Duke University
Durham, North Carolina, United States
Akron Children's Hospital
Akron, Ohio, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States