Recruiting

Phase 2

Phase 3

Inflammation ReversalTargeted Reversal of Inflammation in Pediatric Sepsis-induced MODS

Sponsor:

Nationwide Children's Hospital

Code:

NCT05267821

Conditions

Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome (MODS)

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Interventions

Anakinra

Placebo

Study Details

Brief summary:

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).

Conditions

Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome (MODS)

Study ID

NCT05267821

Start date

Jun 14, 2022

Status verified date

Mar, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

May 15, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

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 Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Anakinra

See information in arm/group descriptions

Placebo

See information in arm/group descriptions

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Mark Hall, MD

6147223438 mark.hall@nationwidechildrens.org

Locations

Children's of Alabama

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Michele Kong, MD

mkong@uabmc.edu

Arkansas Children's Hospital

Recruiting

Little Rock, Arkansas, United States, 72202

Children's Hospital of Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Benioff Children's Hospital - Oakland

Recruiting

Oakland, California, United States, 64609

University of California, Davis

Recruiting

Sacramento, California, United States, 95817

Contacts

MoonJoo Han, MD

800-282-3284 mjohan@ucdavis.edu

Rady Children's Hospital

Recruiting

San Diego, California, United States, 92123

Contacts

Nicole Coufal

858-976-5900 ncoufal@health.ucsd.edu

Benioff Children's Hospital - Mission Bay

Recruiting

San Francisco, California, United States, 94143

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Children's National Medical Center

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Sonali Basu

888-884-2327 sbasu@childrensnational.org

Children's Hospital of Atlanta

Recruiting

Atlanta, Georgia, United States, 30329

Contacts

Jocelyn Grunwell, MD, PhD

jocelyn.grunwell@emory.edu

Riley Children's Hospital

Recruiting

Indianapolis, Indiana, United States, 46204

Contacts

Daniel Cater, MD

317-944-5000 dancater@iu.edu

CS Mott Children's Hospital

Recruiting

Ann Arbor, Michigan, United States, 48109

Children's Hospital of Michigan

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Kathleen Meert, MD

313-745-5437

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Mercy Children's Hospital

Recruiting

Kansas City, Missouri, United States, 64108

Duke University

Recruiting

Durham, North Carolina, United States, 27705

Akron Children's Hospital

Recruiting

Akron, Ohio, United States, 44308

Contacts

Christopher Page-Goertz, MD

CPage-Goertz@akronchildrens.org

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Natalja Stanski, MD

513-636-4200 natalja.stanski@cchmc.org

Rainbow Babies and Children's Hospital

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Kenneth Remy

kenneth.remy@uhhospitals.org

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Mark Hall

614-722-3438 mark.hall@nationwidechildrens.org

Pennsylvania State University

Recruiting

Hershey, Pennsylvania, United States, 17033

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Julie Fitzgerald

fitzgeraldj@chop.edu

Children's Hospital of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15260

Contacts

Joseph Carcillo

carcilloja@ccm.upmc.edu

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

John Costello

costello@musc.edu

University of Texas Southwestern

Recruiting

Dallas, Texas, United States, 75390

Contacts

Matthew Borgman

214-648-3111 Matthew.Borgman@UTSouthwestern.edu

Texas Children's Hospital

Recruiting

Houston, Texas, United States, 77030

Children's Hospital of San Antonio

Recruiting

San Antonio, Texas, United States, 78207

Contacts

Kirstin Henley

kirstin.henley@christushealth.org

Primary Children's Hospital

Recruiting

Salt Lake City, Utah, United States, 84158

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

More Information

Sponsor

Nationwide Children's Hospital

Last update posted

Mar 13, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Nationwide Children's Hospital on 2026-03-13.