Status:
RECRUITING
Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS
Lead Sponsor:
Nationwide Children's Hospital
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome (MODS)
Eligibility:
All Genders
1-17 years
Phase:
PHASE2
PHASE3
Brief Summary
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 chil...
Detailed Description
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 chil...
Eligibility Criteria
Inclusion
- ≥ 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
- 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.
Key Trial Info
Start Date :
June 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2027
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT05267821
Start Date
June 14 2022
End Date
August 31 2027
Last Update
September 2 2025
Active Locations (32)
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1
Children's of Alabama
Birmingham, Alabama, United States, 35233
2
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
3
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
4
Benioff Children's Hospital - Oakland
Oakland, California, United States, 64609