What side effects are associated with this type of intervention?

Common treatments for Sepsis-induced Multiple Organ Dysfunction Syndrome (MODS) include biologic agents like Anakinra, which is an Interleukin-1 Receptor Antagonist. Known side effects of Anakinra include injection site reactions, increased risk of infections, and potential for neutropenia. Other biologic agents used in similar contexts may have overlapping side effects, such as increased susceptibility to infections and potential allergic reactions. It is crucial to monitor patients closely for these adverse effects during treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for conditions related to sepsis-induced Multiple Organ Dysfunction Syndrome (MODS), though specific approvals for MODS itself are limited. Anakinra, an Interleukin-1 Receptor Antagonist, is being studied for its potential in treating sepsis-induced MODS. Other related treatments include Tocilizumab, an IL-6 receptor antagonist, which has been used in inflammatory conditions and may have potential applications in sepsis. These treatments aim to modulate the immune response and reduce inflammation, which is critical in managing sepsis and its complications.

What other types of research exist?

Promising novel alternatives to Anakinra for Sepsis-induced Multiple Organ Dysfunction Syndrome (MODS) include IL-6 inhibitors like Tocilizumab and Sarilumab, which have shown efficacy in other inflammatory conditions. Additionally, Janus kinase (JAK) inhibitors such as Baricitinib and Upadacitinib are being investigated for their anti-inflammatory properties and could be potential options. These therapies target key inflammatory pathways and have shown promise in clinical trials for various inflammatory diseases.

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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

Must not have

History of myeloid leukemia, myelodysplasia, or autoimmune thrombocytopenia

Weight <3kg

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months post-randomization

Summary

This trial tests anakinra, a drug that reduces inflammation, in children with severe inflammation due to sepsis-induced organ failure. Anakinra works by blocking a protein that causes inflammation. It is widely used in treating Rheumatoid Arthritis and has shown potential in managing hyperinflammatory conditions like sepsis.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 40 weeks corrected gestational age but younger than 18 years.

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I have or might have an infection that led to my multiple organ dysfunction syndrome.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of blood disorders like leukemia or low platelet counts due to an autoimmune condition.

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My weight is less than 3 kilograms.

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I am currently breastfeeding.

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My multiple organ dysfunction syndrome (MODS) improved by the second day.

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I have or had hemophagocytic lymphohistiocytosis or macrophage activation syndrome.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cumulative 28-day Pediatric Logistic Organ Dysfunction (PELOD-2) score

Secondary study objectives

3-month functional status

3-month health-related quality of life

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

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Sepsis-induced Multiple Organ Dysfunction Syndrome (MODS) focus on modulating the immune response and controlling inflammation. Anakinra, an Interleukin-1 Receptor Antagonist, blocks the activity of interleukin-1 (IL-1), a key pro-inflammatory cytokine, thereby reducing excessive inflammation that can lead to organ dysfunction. This is vital for sepsis-induced MODS patients as it helps prevent further organ damage and improves survival rates. Other treatments, such as corticosteroids, suppress the immune response to reduce inflammation, while vasopressors maintain blood pressure and organ perfusion. These interventions aim to stabilize the patient's condition by managing the systemic inflammatory response and supporting organ function.