Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS

Recruiting now · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome (MODS)

In brief

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).

Key facts

Study ID

NCT05267821

Run by

Nationwide Children's Hospital

People needed

500

Starts

2022-06-14

Expected to finish

2028-08-31

Last updated by the study team

2026-03-13

Who can join

Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 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 may not qualify 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
• 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.

Where it is running

• Children's of Alabama — Birmingham, Alabama, United States (enrolling)
• Arkansas Children's Hospital — Little Rock, Arkansas, United States (enrolling)
• Children's Hospital of Los Angeles — Los Angeles, California, United States (enrolling)
• Benioff Children's Hospital - Oakland — Oakland, California, United States (enrolling)
• Children's Hospital of San Antonio — San Antonio, Texas, United States (enrolling)
• Primary Children's Hospital — Salt Lake City, Utah, United States (enrolling)
• Virginia Commonwealth University — Richmond, Virginia, United States (enrolling)
• University of California, Davis — Sacramento, California, United States (enrolling)
• Rady Children's Hospital — San Diego, California, United States (enrolling)
• Benioff Children's Hospital - Mission Bay — San Francisco, California, United States (enrolling)
• Children's Hospital Colorado — Aurora, Colorado, United States (enrolling)
• Children's National Medical Center — Washington D.C., District of Columbia, United States (enrolling)
• Children's Hospital of Atlanta — Atlanta, Georgia, United States (enrolling)
• Riley Children's Hospital — Indianapolis, Indiana, United States (enrolling)
• CS Mott Children's Hospital — Ann Arbor, Michigan, United States (enrolling)
• Children's Hospital of Michigan — Detroit, Michigan, United States (enrolling)
• University of Minnesota — Minneapolis, Minnesota, United States (enrolling)
• Mercy Children's Hospital — Kansas City, Missouri, United States (enrolling)
• Duke University — Durham, North Carolina, United States (enrolling)
• Akron Children's Hospital — Akron, Ohio, United States (enrolling)
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (enrolling)
• Rainbow Babies and Children's Hospital — Cleveland, Ohio, United States (enrolling)
• Nationwide Children's Hospital — Columbus, Ohio, United States (enrolling)
• Pennsylvania State University — Hershey, Pennsylvania, United States (enrolling)
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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