What this study is
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).
What's being tested
- Anakinra
Intervention · DRUG
- Placebo
Intervention · DRUG
Both interventions
See information in arm/group descriptions
Study details
- Official title
- Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS (TRIPS)
- Sponsor
- Nationwide Children's Hospital
- Conditions
- Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome (MODS)
- Enrolling
- 500 people
- Starts
- 2022-06-14
- Est. completion
- 2028-08-31
- Design
- Quadruple-blind, randomized, parallel groups, Phase 2, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 1 Day – 17 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- ≥ 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (32)
32 open- Recruiting
Arkansas Children's Hospital
Little Rock, Arkansas, United States
- Ronald Sanders · Contact
RecruitingChildren's Hospital of Los Angeles
Los Angeles, California, United States
- Robinder Khemani · Contact
RecruitingBenioff Children's Hospital - Oakland
Oakland, California, United States
- Natalie Cvijanovich · Contact
RecruitingChildren's Hospital of Orange County
Orange, California, United States
- Adam Schwarz · Contact
Not yet recruitingUniversity of California, Davis
Sacramento, California, United States
- MoonJoo Han, MD · Contact800-282-3284mjohan@ucdavis.edu
RecruitingRady Children's Hospital
San Diego, California, United States
- Nicole Coufal · Contact858-976-5900ncoufal@health.ucsd.edu
RecruitingBenioff Children's Hospital - Mission Bay
San Francisco, California, United States
- Patrick McQuillen · Contact
RecruitingChildren's Hospital Colorado
Aurora, Colorado, United States
- Eva Nozik · Contact
RecruitingChildren's National Medical Center
Washington D.C., District of Columbia, United States
- Sonali Basu · Contact888-884-2327sbasu@childrensnational.org
RecruitingChildren's Hospital of Atlanta
Atlanta, Georgia, United States
- Jocelyn Grunwell, MD, PhD · Contactjocelyn.grunwell@emory.edu
RecruitingRiley Children's Hospital
Indianapolis, Indiana, United States
- Daniel Cater, MD · Contact317-944-5000dancater@iu.edu
RecruitingCS Mott Children's Hospital
Ann Arbor, Michigan, United States
- Michael Quasney · Contact
RecruitingChildren's Hospital of Michigan
Detroit, Michigan, United States
- Kathleen Meert, MD · Contact313-745-5437
RecruitingChildren's Hospital of Minnesota
Minneapolis, Minnesota, United States
- Alberto Orioles · Contact
Not yet recruitingUniversity of Minnesota
Minneapolis, Minnesota, United States
- Marie Steiner · Contact
RecruitingMercy Children's Hospital
Kansas City, Missouri, United States
- Yong Han · Contact
RecruitingDuke University
Durham, North Carolina, United States
- Christoph Hornik · Contact
RecruitingAkron Children's Hospital
Akron, Ohio, United States
- Christopher Page-Goertz, MD · ContactCPage-Goertz@akronchildrens.org
RecruitingCincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
- Natalja Stanski, MD · Contact513-636-4200natalja.stanski@cchmc.org
RecruitingRainbow Babies and Children's Hospital
Cleveland, Ohio, United States
- Kenneth Remy · Contactkenneth.remy@uhhospitals.org
RecruitingNationwide Children's Hospital
Columbus, Ohio, United States
- Mark Hall · Contact614-722-3438mark.hall@nationwidechildrens.org
RecruitingPennsylvania State University
Hershey, Pennsylvania, United States
- Neal Thomas · Contact
RecruitingChildren's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
- Julie Fitzgerald · Contactfitzgeraldj@chop.edu
RecruitingChildren's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
- Joseph Carcillo · Contactcarcilloja@ccm.upmc.edu
RecruitingMedical University of South Carolina
Charleston, South Carolina, United States
- John Costello · Contactcostello@musc.edu
RecruitingUniversity of Texas Southwestern
Dallas, Texas, United States
- Matthew Borgman · Contact214-648-3111Matthew.Borgman@UTSouthwestern.edu
RecruitingTexas Children's Hospital
Houston, Texas, United States
- Ayse Arikan · Contact
RecruitingChildren's Hospital of San Antonio
San Antonio, Texas, United States
- Kirstin Henley · Contactkirstin.henley@christushealth.org
RecruitingPrimary Children's Hospital
Salt Lake City, Utah, United States
- Jill Sweney · Contact
RecruitingVirginia Commonwealth University
Richmond, Virginia, United States
- Nikki Miller-Ferguson · Contact
RecruitingMedical College of Wisconsin
Milwaukee, Wisconsin, United States
- Nathan Thompson · Contact
Not yet recruiting
Study team
Sponsor
Nationwide Children's Hospital
Study ID TRIPS
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.