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Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS

RecruitingPhase 2/3

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

Who can join

1 Day – 17 Years · All sexes

Full eligibility criteria
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.

About the study

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).

What is being tested

Sponsor: Nationwide Children's Hospital · Participants: 500 · Started: Jun 14, 2022

Contact the study team

Official record on ClinicalTrials.gov — NCT05267821

Locations in the U.S.

AlabamaChildren's of Alabama, Birmingham
ArkansasArkansas Children's Hospital, Little Rock
CaliforniaChildren's Hospital of Los Angeles, Los Angeles
Benioff Children's Hospital - Oakland, Oakland
Children's Hospital of Orange County, Orange (Not yet recruiting)
University of California, Davis, Sacramento
Rady Children's Hospital, San Diego
Benioff Children's Hospital - Mission Bay, San Francisco
ColoradoChildren's Hospital Colorado, Aurora
District of ColumbiaChildren's National Medical Center, Washington D.C.
GeorgiaChildren's Hospital of Atlanta, Atlanta
IndianaRiley Children's Hospital, Indianapolis
MichiganCS Mott Children's Hospital, Ann Arbor
Children's Hospital of Michigan, Detroit
MinnesotaChildren's Hospital of Minnesota, Minneapolis (Not yet recruiting)
University of Minnesota, Minneapolis
MissouriMercy Children's Hospital, Kansas City
North CarolinaDuke University, Durham
OhioAkron Children's Hospital, Akron
Cincinnati Children's Hospital Medical Center, Cincinnati
Rainbow Babies and Children's Hospital, Cleveland
Nationwide Children's Hospital, Columbus
PennsylvaniaPennsylvania State University, Hershey
Children's Hospital of Philadelphia, Philadelphia
Children's Hospital of Pittsburgh, Pittsburgh
South CarolinaMedical University of South Carolina, Charleston
TexasUniversity of Texas Southwestern, Dallas
Texas Children's Hospital, Houston
Children's Hospital of San Antonio, San Antonio
UtahPrimary Children's Hospital, Salt Lake City
VirginiaVirginia Commonwealth University, Richmond
WisconsinMedical College of Wisconsin, Milwaukee (Not yet recruiting)

From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.