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

Primary Purpose

Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome (MODS)

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Anakinra
Placebo
Sponsored by
Nationwide Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome (MODS)

Eligibility Criteria

1 Day - 17 Years (Child)All SexesDoes not accept healthy volunteers

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
  • History of myeloid leukemia, myelodysplasia, or autoimmune thrombocytopenia; 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 therapyOR 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 or GM-CSF within the previous 28 days; OR
  • Resolution of MODS by MODS Day 2; OR
  • Previous enrollment in the TRIPS study.

Sites / Locations

  • Arkansas Children's HospitalRecruiting
  • Children's Hospital of Los AngelesRecruiting
  • Benioff Children's Hospital - OaklandRecruiting
  • Children's Hospital of Orange County
  • Benioff Children's Hospital - Mission BayRecruiting
  • Children's Hospital ColoradoRecruiting
  • Children's National Medical CenterRecruiting
  • CS Mott Children's HospitalRecruiting
  • Children's Hospital of MichiganRecruiting
  • Children's Hospital of Minnesota
  • University of MinnesotaRecruiting
  • Mercy Children's HospitalRecruiting
  • Duke UniversityRecruiting
  • Rainbow Babies and Children's HospitalRecruiting
  • Nationwide Children's HospitalRecruiting
  • Pennsylvania State UniversityRecruiting
  • Children's Hospital of PhiladelphiaRecruiting
  • Children's Hospital of PittsburghRecruiting
  • Medical University of South CarolinaRecruiting
  • Texas Children's HospitalRecruiting
  • Children's Hospital of San AntonioRecruiting
  • Primary Children's HospitalRecruiting
  • Virginia Commonwealth UniversityRecruiting
  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Anakinra 4 mg/kg/day

Anakinra 8 mg/kg/day

Anakinra 12 mg/kg/day

Anakinra 16 mg/kg/day

Placebo

Arm Description

IV Anakinra 4mg/kg/day x 7 days

IV Anakinra 8 mg/kg/day x 7 days

IV Anakinra 12 mg/kg/day x 7 days

IV Anakinra 16 mg/kg/day x 7 days

IV placebo x 7 days

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

3-month health-related quality of life
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-month functional status
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.

Full Information

First Posted
February 24, 2022
Last Updated
February 7, 2023
Sponsor
Nationwide Children's Hospital
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT05267821
Brief Title
Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS
Acronym
TRIPS
Official Title
Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS (TRIPS)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 14, 2022 (Actual)
Primary Completion Date
May 15, 2027 (Anticipated)
Study Completion Date
August 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nationwide Children's Hospital
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome (MODS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Prospective, adaptively-randomized, double-blind, placebo controlled clinical trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anakinra 4 mg/kg/day
Arm Type
Active Comparator
Arm Description
IV Anakinra 4mg/kg/day x 7 days
Arm Title
Anakinra 8 mg/kg/day
Arm Type
Active Comparator
Arm Description
IV Anakinra 8 mg/kg/day x 7 days
Arm Title
Anakinra 12 mg/kg/day
Arm Type
Active Comparator
Arm Description
IV Anakinra 12 mg/kg/day x 7 days
Arm Title
Anakinra 16 mg/kg/day
Arm Type
Active Comparator
Arm Description
IV Anakinra 16 mg/kg/day x 7 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
IV placebo x 7 days
Intervention Type
Drug
Intervention Name(s)
Anakinra
Intervention Description
See information in arm/group descriptions
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
See information in arm/group descriptions
Primary Outcome Measure Information:
Title
Cumulative 28-day Pediatric Logistic Organ Dysfunction (PELOD-2) score
Description
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.
Time Frame
28 days from randomization
Secondary Outcome Measure Information:
Title
3-month health-related quality of life
Description
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.
Time Frame
3 months post-randomization
Title
3-month functional status
Description
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.
Time Frame
3 months post-randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 History of myeloid leukemia, myelodysplasia, or autoimmune thrombocytopenia; 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 therapyOR 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 or GM-CSF within the previous 28 days; OR Resolution of MODS by MODS Day 2; OR Previous enrollment in the TRIPS study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Hall, MD
Phone
6147223438
Email
mark.hall@nationwidechildrens.org
Facility Information:
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronald Sanders
Facility Name
Children's Hospital of Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robinder Khemani
Facility Name
Benioff Children's Hospital - Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
64609
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natalie Cvijanovich
Facility Name
Children's Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Schwarz
Facility Name
Benioff Children's Hospital - Mission Bay
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick McQuillen
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Nozik
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Bell
Facility Name
CS Mott Children's Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Quasney
Facility Name
Children's Hospital of Michigan
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathleen Meert, MD
Phone
313-745-5437
Facility Name
Children's Hospital of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alberto Orioles
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Steiner
Facility Name
Mercy Children's Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Han
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christoph Hornik
Facility Name
Rainbow Babies and Children's Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven Shein
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Hall
Phone
614-722-3438
Email
mark.hall@nationwidechildrens.org
Facility Name
Pennsylvania State University
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neal Thomas
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Berg
Facility Name
Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Carcillo
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Costello
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ayse Arikan
Facility Name
Children's Hospital of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammed Salameh
Facility Name
Primary Children's Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84158
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jill Sweney
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nikki Miller-Ferguson
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53233
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathan Thompson

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS

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