Reversing inflammation in children with sepsis-induced organ dysfunction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Children's of Alabama
  Birmingham, Alabama, United States Recruiting
• Arkansas Children's Hospital
  Little Rock, Arkansas, United States Recruiting
• Children's Hospital of Los Angeles
  Los Angeles, California, United States Recruiting
• Benioff Children's Hospital - Oakland
  Oakland, California, United States Recruiting
• University of California, Davis
  Sacramento, California, United States Recruiting
• Rady Children's Hospital
  San Diego, California, United States Recruiting

Study contacts

• Study coordinator: Mark Hall, MD
• Email: mark.hall@nationwidechildrens.org
• Phone: 6147223438

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.