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NCT05267821 · ClinicalTrials.gov registry record · Phase 2
Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS
A Phase 2 study of Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome (MODS), sponsored by Nationwide Children's Hospital.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 500
- Enrollment target
- 20
- Study locations
NCT05267821: Recruiting Phase 2 study of Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome (MODS), sponsored by Nationwide Children's Hospital.
NCT05267821 is a Phase 2 study of Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome (MODS) that is actively recruiting participants, run by Nationwide Children's Hospital. The registered enrollment target is 500 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (276% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05267821, a Phase 2 study of Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome (MODS), is actively recruiting participants, sponsored by Nationwide Children's Hospital.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 500 participants
- Enrollment target
- 20
- Study locations
Study 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).
Primary Outcome
The cumulative Pediatric Logistic Organ Dysfunction (PELOD)-2 score over 28 days from randomization. The range of daily PELOD-2 scores is from 0 - 33, with higher scores representing worse organ function.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Anakinra
Study Locations (20)
California
- Children's Hospital of Los Angeles - Los Angeles
- Benioff Children's Hospital - Oakland - Oakland
- Children's Hospital of Orange County - Orange
- University of California, Davis - Sacramento
- Rady Children's Hospital - San Diego
- Benioff Children's Hospital - Mission Bay - San Francisco
Michigan
- CS Mott Children's Hospital - Ann Arbor
- Children's Hospital of Michigan - Detroit
Minnesota
- Children's Hospital of Minnesota - Minneapolis
- University of Minnesota - Minneapolis
Ohio
- Akron Children's Hospital - Akron
- Cincinnati Children's Hospital Medical Center - Cincinnati
Alabama
- Children's of Alabama - Birmingham
Arkansas
- Arkansas Children's Hospital - Little Rock
Colorado
- Children's Hospital Colorado - Aurora
District of Columbia
- Children's National Medical Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2022-06-14 |
| Est. Completion | 2028-08-31 |
| Phase | Phase 2 |
What NCT05267821 shows while recruiting
NCT05267821 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (276% higher).
The record links to 1 condition, with Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome (MODS) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05267821 names 20 study sites across 12 states, led by California, Michigan, Minnesota.
Frequently Asked Questions
What is clinical trial NCT05267821 about?
NCT05267821 is a clinical study titled "Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS". 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).
What is the current status of trial NCT05267821?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 500 participants. The study started on 2022-06-14. Estimated completion is 2028-08-31.
What conditions does trial NCT05267821 study?
This clinical trial studies the following conditions: Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome (MODS).
What interventions are being tested in trial NCT05267821?
The interventions under investigation include: Placebo (DRUG), Anakinra (DRUG).
Who is sponsoring clinical trial NCT05267821?
This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05267821 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05267821's enrollment target sits among peer trials
500 70th of 2000 higher than 1,928 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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