Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS
Start Date
6/14/2022
Completion Date
8/31/2028
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.
Eligibility Criteria
Age Range: No minimum to 17 years
Interventions
Anakinra
Placebo
Conditions
Locations
Children's of Alabama
Birmingham, Alabama 35233
United States
Arkansas Children's Hospital
Little Rock, Arkansas 72202
United States
Children's Hospital of Los Angeles
Los Angeles, California 90027
United States
Benioff Children's Hospital - Oakland
Oakland, California 64609
United States
Children's Hospital of Orange County
Orange, California 92868
United States
University of California, Davis
Sacramento, California 95817
United States
Rady Children's Hospital
San Diego, California 92123
United States
Benioff Children's Hospital - Mission Bay
San Francisco, California 94143
United States
Children's Hospital Colorado
Aurora, Colorado 80045
United States
Children's National Medical Center
Washington D.C., District of Columbia 20010
United States
Children's Hospital of Atlanta
Atlanta, Georgia 30329
United States
Riley Children's Hospital
Indianapolis, Indiana 46204
United States
CS Mott Children's Hospital
Ann Arbor, Michigan 48109
United States
Children's Hospital of Michigan
Detroit, Michigan 48201
United States
Children's Hospital of Minnesota
Minneapolis, Minnesota 55404
United States
University of Minnesota
Minneapolis, Minnesota 55455
United States
Mercy Children's Hospital
Kansas City, Missouri 64108
United States
Duke University
Durham, North Carolina 27705
United States
Akron Children's Hospital
Akron, Ohio 44308
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
United States
Rainbow Babies and Children's Hospital
Cleveland, Ohio 44106
United States
Nationwide Children's Hospital
Columbus, Ohio 43205
United States
Pennsylvania State University
Hershey, Pennsylvania 17033
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania 15260
United States
Medical University of South Carolina
Charleston, South Carolina 29425
United States
University of Texas Southwestern
Dallas, Texas 75390
United States
Texas Children's Hospital
Houston, Texas 77030
United States
Children's Hospital of San Antonio
San Antonio, Texas 78207
United States
Primary Children's Hospital
Salt Lake City, Utah 84158
United States
Virginia Commonwealth University
Richmond, Virginia 23298
United States
Medical College of Wisconsin
Milwaukee, Wisconsin 53233
United States