Actively Recruiting
Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS
Led by Nationwide Children's Hospital · Updated on 2026-03-13
500
Participants Needed
32
Research Sites
324 weeks
Total Duration
On this page
Sponsors
N
Nationwide Children's Hospital
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 40 weeks corrected gestational age and under 18 years old
- Admitted to the pediatric intensive care unit (PICU) or cardiac intensive care unit (CICU)
- Onset of two or more new organ dysfunctions within the last 3 calendar days compared to pre-sepsis baseline
- Documented or suspected infection triggering the MODS
You will not qualify if you...
- Weighs less than 3 kilograms
- Has a limitation of care order at screening
- High likelihood of progressing to brain death as judged by clinical team
- Moribund condition unlikely to survive next 48 hours as judged by clinical team
- Current or prior diagnosis of hemophagocytic lymphohistiocytosis or macrophage activation syndrome
- Peripheral white blood cell count under 1,000 cells/mm3 due to myeloablative therapy or received such therapy within previous 14 days
- Known allergy to anakinra or E. coli-derived products
- Known pregnancy or lactating female
- Received anakinra within previous 28 days
- MODS resolved by day 2
- Previously enrolled in the TRIPS study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 32 locations
1
Children's of Alabama
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
Actively Recruiting
3
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
4
Benioff Children's Hospital - Oakland
Oakland, California, United States, 64609
Actively Recruiting
5
Children's Hospital of Orange County
Orange, California, United States, 92868
Not Yet Recruiting
6
University of California, Davis
Sacramento, California, United States, 95817
Actively Recruiting
7
Rady Children's Hospital
San Diego, California, United States, 92123
Actively Recruiting
8
Benioff Children's Hospital - Mission Bay
San Francisco, California, United States, 94143
Actively Recruiting
9
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
10
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
11
Children's Hospital of Atlanta
Atlanta, Georgia, United States, 30329
Actively Recruiting
12
Riley Children's Hospital
Indianapolis, Indiana, United States, 46204
Actively Recruiting
13
CS Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
14
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
Actively Recruiting
15
Children's Hospital of Minnesota
Minneapolis, Minnesota, United States, 55404
Not Yet Recruiting
16
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
17
Mercy Children's Hospital
Kansas City, Missouri, United States, 64108
Actively Recruiting
18
Duke University
Durham, North Carolina, United States, 27705
Actively Recruiting
19
Akron Children's Hospital
Akron, Ohio, United States, 44308
Actively Recruiting
20
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
21
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106
Actively Recruiting
22
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
23
Pennsylvania State University
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
24
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
25
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15260
Actively Recruiting
26
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
27
University of Texas Southwestern
Dallas, Texas, United States, 75390
Actively Recruiting
28
Texas Children's Hospital
Houston, Texas, United States, 77030
Actively Recruiting
29
Children's Hospital of San Antonio
San Antonio, Texas, United States, 78207
Actively Recruiting
30
Primary Children's Hospital
Salt Lake City, Utah, United States, 84158
Actively Recruiting
31
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Actively Recruiting
32
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53233
Not Yet Recruiting
Research Team
M
Mark Hall, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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