Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS (TRIPS)

March 11, 2026 updated by: Mark Hall, Nationwide Children's Hospital

Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS (TRIPS)

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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). Eligible subjects will undergo centralized immunophenotyping on day 2 of MODS. Subjects without immunoparalysis (a whole blood ex vivo LPS-induced TNF-alpha production capacity < 200 pg/ml) and a serum ferritin level of 500 - 2,000 ng/ml or a serum C-reactive protein (CRP) ≥ 4 mg/dl will be eligible for randomization, along with subjects with a serum ferritin level of 2,000 - 10,000 ng/ml regardless of their TNF-alpha response. Eligible subjects will receive intravenous (IV) anakinra at a dose of 4, 8, 12, or 16 mg/kg/day or placebo for 7 days.

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • Children's of Alabama
        • Contact:
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Recruiting
        • Arkansas Children's Hospital
        • Contact:
          • Ronald Sanders
    • California
      • Los Angeles, California, United States, 90027
        • Recruiting
        • Children's Hospital of Los Angeles
        • Contact:
          • Robinder Khemani
      • Oakland, California, United States, 64609
        • Recruiting
        • Benioff Children's Hospital - Oakland
        • Contact:
          • Natalie Cvijanovich
      • Orange, California, United States, 92868
        • Not yet recruiting
        • Children's Hospital of Orange County
        • Contact:
          • Adam Schwarz
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California, Davis
        • Contact:
      • San Diego, California, United States, 92123
        • Recruiting
        • Rady Children's Hospital
        • Contact:
      • San Francisco, California, United States, 94143
        • Recruiting
        • Benioff Children's Hospital - Mission Bay
        • Contact:
          • Patrick McQuillen
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Children's Hospital Colorado
        • Contact:
          • Eva Nozik
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
    • Georgia
      • Atlanta, Georgia, United States, 30329
    • Indiana
      • Indianapolis, Indiana, United States, 46204
        • Recruiting
        • Riley Children's Hospital
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • CS Mott Children's Hospital
        • Contact:
          • Michael Quasney
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Children's Hospital of Michigan
        • Contact:
          • Kathleen Meert, MD
          • Phone Number: 313-745-5437
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Contact:
          • Marie Steiner
      • Minneapolis, Minnesota, United States, 55404
        • Not yet recruiting
        • Children's Hospital of Minnesota
        • Contact:
          • Alberto Orioles
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Recruiting
        • Mercy Children's Hospital
        • Contact:
          • Yong Han
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Duke University
        • Contact:
          • Christoph Hornik
    • Ohio
      • Akron, Ohio, United States, 44308
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital Medical Center
        • Contact:
      • Cleveland, Ohio, United States, 44106
      • Columbus, Ohio, United States, 43205
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Recruiting
        • Pennsylvania State University
        • Contact:
          • Neal Thomas
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Children's Hospital of Philadelphia
        • Contact:
      • Pittsburgh, Pennsylvania, United States, 15260
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75390
      • Houston, Texas, United States, 77030
        • Recruiting
        • Texas Children's Hospital
        • Contact:
          • Ayse Arikan
      • San Antonio, Texas, United States, 78207
    • Utah
      • Salt Lake City, Utah, United States, 84158
        • Recruiting
        • Primary Children's Hospital
        • Contact:
          • Jill Sweney
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University
        • Contact:
          • Nikki Miller-Ferguson
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53233
        • Not yet recruiting
        • Medical College of Wisconsin
        • Contact:
          • Nathan Thompson

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ≥ 40 weeks corrected gestational age to < 18 years; AND
  • Admission to the PICU or CICU; AND
  • Onset of ≥ 2 new organ dysfunctions within the last 3 calendar days (compared to pre-sepsis baseline) as measured by the modified Proulx criteria; AND
  • Documented or suspected infection as the MODS inciting event.

Exclusion Criteria:

  • Weight <3kg; OR
  • Limitation of care order at the time of screening; OR
  • Patients at high likelihood of progression to brain death in opinion of the clinical team; OR
  • Moribund condition in which the patient is unlikely to survive the next 48 hours in opinion of the clinical team; OR
  • Current or prior diagnosis of hemophagocytic lymphohistiocytosis or macrophage activation syndrome; OR
  • Peripheral white blood cell count < 1,000 cells/mm3 as the result of myeloablative therapy OR receipt of myeloablative therapy within the previous 14 days; OR
  • Known allergy to anakinra, or E. coli-derived products; OR
  • Known pregnancy; OR
  • Lactating females; OR
  • Receipt of anakinra within the previous 28 days; OR
  • Resolution of MODS by MODS Day 2; OR
  • Previous enrollment in the TRIPS study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Anakinra 4 mg/kg/day
IV Anakinra 4mg/kg/day x 7 days
Drug: Anakinra
See information in arm/group descriptions
Active Comparator: Anakinra 8 mg/kg/day
IV Anakinra 8 mg/kg/day x 7 days
Drug: Anakinra
See information in arm/group descriptions
Active Comparator: Anakinra 12 mg/kg/day
IV Anakinra 12 mg/kg/day x 7 days
Drug: Anakinra
See information in arm/group descriptions
Active Comparator: Anakinra 16 mg/kg/day
IV Anakinra 16 mg/kg/day x 7 days
Drug: Anakinra
See information in arm/group descriptions
Placebo Comparator: Placebo
IV placebo x 7 days
Drug: Placebo
See information in arm/group descriptions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative 28-day Pediatric Logistic Organ Dysfunction (PELOD-2) score
Time Frame: 28 days from randomization
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.
28 days from randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-month health-related quality of life
Time Frame: 3 months post-randomization
The change in Pediatric Quality of Life inventory (PedsQL) score from baseline to 3-months post-randomization. The PedsQL score ranges from 0 - 100, with higher values indicating better quality of life.
3 months post-randomization
3-month functional status
Time Frame: 3 months post-randomization
The change in Functional Status Score (FSS) from baseline to 3-months post-randomization. The FSS score ranges from 6 - 30, with higher scores indicating worse functional status.
3 months post-randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nationwide Children's Hospital

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 14, 2022

Primary Completion (Estimated)

May 15, 2028

Study Completion (Estimated)

August 31, 2028

Study Registration Dates

First Submitted

February 24, 2022

First Submitted That Met QC Criteria

February 24, 2022

First Posted (Actual)

March 4, 2022

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRIPS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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