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Interleukin-1 Receptor Antagonist
Anakinra for Pediatric Multiple Organ Failure (TRIPS Trial)
Phase 2 & 3
Recruiting
Research Sponsored by Nationwide Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
≥ 40 weeks corrected gestational age to < 18 years
Documented or suspected infection as the MODS inciting event
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months post-randomization
Awards & highlights
TRIPS Trial Summary
This trial is testing a drug called anakinra to see if it can help reverse severe inflammation in children with sepsis-induced multiple organ dysfunction syndrome (MODS).
Who is the study for?
This trial is for children from newborns up to 17 years old with severe inflammation due to sepsis-induced organ failure. They must have had a recent worsening in organ function and suspected or confirmed infection causing it. Kids can't join if they're under 3kg, pregnant, lactating, have certain blood disorders or immune conditions, are likely to die within 48 hours, or previously received specific treatments.Check my eligibility
What is being tested?
The TRIPS study tests the drug Anakinra against a placebo in kids with sepsis-induced multiple organ dysfunction syndrome (MODS). It's a double-blind trial meaning neither doctors nor patients know who gets the real drug versus the placebo. The goal is to see if Anakinra can reverse severe inflammation.See study design
What are the potential side effects?
Anakinra may cause allergic reactions because it's made from E. coli bacteria products. Other side effects could include increased risk of infections due to its effect on the immune system.
TRIPS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 40 weeks corrected gestational age but younger than 18 years.
Select...
I have or might have an infection that led to my multiple organ dysfunction syndrome.
TRIPS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months post-randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months post-randomization
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cumulative 28-day Pediatric Logistic Organ Dysfunction (PELOD-2) score
Secondary outcome measures
3-month functional status
3-month health-related quality of life
TRIPS Trial Design
5Treatment groups
Active Control
Placebo Group
Group I: Anakinra 16 mg/kg/dayActive Control1 Intervention
IV Anakinra 16 mg/kg/day x 7 days
Group II: Anakinra 8 mg/kg/dayActive Control1 Intervention
IV Anakinra 8 mg/kg/day x 7 days
Group III: Anakinra 12 mg/kg/dayActive Control1 Intervention
IV Anakinra 12 mg/kg/day x 7 days
Group IV: Anakinra 4 mg/kg/dayActive Control1 Intervention
IV Anakinra 4mg/kg/day x 7 days
Group V: PlaceboPlacebo Group1 Intervention
IV placebo x 7 days
Find a Location
Who is running the clinical trial?
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,977 Previous Clinical Trials
2,680,297 Total Patients Enrolled
Nationwide Children's HospitalLead Sponsor
341 Previous Clinical Trials
5,219,999 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have or might have an infection that led to my multiple organ dysfunction syndrome.My white blood cell count is low due to recent intense therapy.My weight is less than 3 kilograms.I have a history of blood disorders like leukemia or low platelet counts due to an autoimmune condition.I am currently breastfeeding.My multiple organ dysfunction syndrome (MODS) improved by the second day.I am older than 40 weeks corrected gestational age but younger than 18 years.I have not taken anakinra or GM-CSF in the last 28 days.I have or had hemophagocytic lymphohistiocytosis or macrophage activation syndrome.
Research Study Groups:
This trial has the following groups:- Group 1: Anakinra 16 mg/kg/day
- Group 2: Anakinra 8 mg/kg/day
- Group 3: Anakinra 12 mg/kg/day
- Group 4: Anakinra 4 mg/kg/day
- Group 5: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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