Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS

Conditions

• Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome (MODS)

Eligibility Criteria

Sex

ALL

Age

1 Day - 17 Years

Healthy Volunteers

Not accepted

Interventions

• Anakinra — DRUG
  See information in arm/group descriptions
• Placebo — DRUG
  See information in arm/group descriptions

Study Details

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).

Key Dates

Start date

Jun 14, 2022

Status verified

Mar 2026

Primary completion

May 15, 2028

Completion

Aug 31, 2028

Study Design

Enrollment

500 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Anakinra 4 mg/kg/day
  IV Anakinra 4mg/kg/day x 7 days
• Active Comparator: Anakinra 8 mg/kg/day
  IV Anakinra 8 mg/kg/day x 7 days
• Active Comparator: Anakinra 12 mg/kg/day
  IV Anakinra 12 mg/kg/day x 7 days
• Active Comparator: Anakinra 16 mg/kg/day
  IV Anakinra 16 mg/kg/day x 7 days
• Placebo Comparator: Placebo
  IV placebo x 7 days

Primary Outcome Measure

Cumulative 28-day Pediatric Logistic Organ Dysfunction (PELOD-2) score [ Time Frame: 28 days from randomization ]

Central Contacts

• Mark Hall, MD
  6147223438
  [email protected]

Locations (32)

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