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Reversing inflammation in children with sepsis-induced organ dysfunction

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

Phase2; Phase3 Interventional Nationwide Children's Hospital · NCT05267821

This study is testing if a drug called anakinra can help children with sepsis-induced organ problems by reducing inflammation.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment500 (estimated)
Ages1 Day to 17 Years
SexAll
SponsorNationwide Children's Hospital Academic / other
Locations32 sites (Birmingham, Alabama and 31 other locations)
Trial IDNCT05267821 on ClinicalTrials.gov

What this trial studies

The TRIPS study is a multi-center, double-blind, randomized clinical trial investigating the use of anakinra, a drug aimed at reversing hyperinflammation in children suffering from sepsis-induced multiple organ dysfunction syndrome (MODS). Eligible participants will be children aged from 40 weeks corrected gestational age to under 18 years who have developed two or more new organ dysfunctions within three days of sepsis onset. The trial will involve administering intravenous anakinra or a placebo for seven days, with careful monitoring of immunological responses. Centralized immunophenotyping will be conducted to assess eligibility based on specific inflammatory markers.

Who should consider this trial

Good fit: Ideal candidates are children aged 40 weeks to under 18 years with recent onset of multiple organ dysfunction due to sepsis.

Not a fit: Patients with severe underlying conditions or those unlikely to survive the next 48 hours may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve recovery outcomes for children suffering from severe sepsis-induced organ dysfunction.

How similar studies have performed: Other studies have explored similar approaches to treating sepsis-induced inflammation, but the specific use of anakinra in this context is novel.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Birmingham, Alabama and 31 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.