Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age1-17
SponsorNationwide Children's Hospital
About this trial
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).
Eligibility criteria
Qualifiers
≥ 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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Anakinra
- Placebo
Treatment groups
500 Participants
are divided into 5 treatment groupsSponsors and collaborators
Nationwide Children's Hospital
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov