NCT05267821 Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS
| NCT ID | NCT05267821 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Nationwide Children's Hospital |
| Condition | Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome (MODS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2022-06-14 |
| Primary Completion | 2028-05-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 500 participants in total. It began in 2022-06-14 with a primary completion date of 2028-05-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 children with sepsis-induced multiple organ dysfunction syndrome (MODS).
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05267821 clinical trial?
This trial is open to participants of all sexes, aged 1 Day or older, up to 17 Years, studying Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome (MODS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05267821 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05267821 currently recruiting?
Yes, NCT05267821 is actively recruiting participants. Contact the research team at mark.hall@nationwidechildrens.org for enrollment information.
Where is the NCT05267821 trial being conducted?
This trial is being conducted at Birmingham, United States, Little Rock, United States, Los Angeles, United States, Oakland, United States and 11 additional locations.
Who is sponsoring the NCT05267821 clinical trial?
NCT05267821 is sponsored by Nationwide Children's Hospital. The trial plans to enroll 500 participants.