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โ† Trials
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Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS

RecruitingPhase 2, Phase 3Ages 1 Day - 17 YearsAllNationwide Children's Hospital
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * โ‰ฅ 40 weeks corrected gestational age to \< 18 years; AND * Admission to the PICU or CICU; AND * Onset of โ‰ฅ 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.
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What it tests

  • Anakinra
  • Placebo
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Where

32 sites
Children's of Alabama
Birmingham, United States
Arkansas Children's Hospital
Little Rock, United States
Children's Hospital of Los Angeles
Los Angeles, United States
Benioff Children's Hospital - Oakland
Oakland, United States
Children's Hospital of Orange County
Orange, United States
University of California, Davis
Sacramento, United States
Rady Children's Hospital
San Diego, United States
Benioff Children's Hospital - Mission Bay
San Francisco, United States

โ€ฆand 24 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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