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Interleukin-1 Receptor Antagonist

Anakinra for Pediatric Multiple Organ Failure (TRIPS Trial)

Q: Are there any patients that have not yet been enrolled in this clinical trial?

The clinical trial is still recruiting patients, based on the information available on clinicaltrials.gov. The study was first posted on June 8th, 2022, and was most recently updated on October 3rd, 2022.

Q: If a patient were interested in enrolling in this research, would they have multiple options in terms of location?

There are 25 sites administering this trial currently. If you are interested in participating, try to select a location close to you to minimize travel as the sites are located in Cleveland, Milwaukee, Oakland, and other cities.

Q: For this particular test, are elderly patients above a certain age limit being accepted?

This trial is looking for young patients that are older than 1 Day old, but not yet 17 years old.

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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months post-randomization for reporting.

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 4 mg/kg/dayActive Control1 Intervention

IV Anakinra 4mg/kg/day x 7 days

Group IV: Anakinra 12 mg/kg/dayActive Control1 Intervention

IV Anakinra 12 mg/kg/day x 7 days

Group V: PlaceboPlacebo Group1 Intervention

IV placebo x 7 days

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH

1,965 Previous Clinical Trials

2,672,297 Total Patients Enrolled

Nationwide Children's HospitalLead Sponsor

341 Previous Clinical Trials

5,220,006 Total Patients Enrolled

Media Library

Anakinra (Interleukin-1 Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05267821 — Phase 2 & 3

Sepsis-induced Multiple Organ Dysfunction Syndrome Research Study Groups: Anakinra 16 mg/kg/day, Anakinra 8 mg/kg/day, Anakinra 4 mg/kg/day, Anakinra 12 mg/kg/day, Placebo

Sepsis-induced Multiple Organ Dysfunction Syndrome Clinical Trial 2023: Anakinra Highlights & Side Effects. Trial Name: NCT05267821 — Phase 2 & 3

Anakinra (Interleukin-1 Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05267821 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any patients that have not yet been enrolled in this clinical trial?

"The clinical trial is still recruiting patients, based on the information available on clinicaltrials.gov. The study was first posted on June 8th, 2022, and was most recently updated on October 3rd, 2022."

Answered by AI

If a patient were interested in enrolling in this research, would they have multiple options in terms of location?

"There are 25 sites administering this trial currently. If you are interested in participating, try to select a location close to you to minimize travel as the sites are located in Cleveland, Milwaukee, Oakland, and other cities."

Answered by AI