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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05267821
Recruitment Status : Not yet recruiting
First Posted : March 4, 2022
Last Update Posted : May 10, 2022
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Mark Hall, Nationwide Children's Hospital

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).

Condition or disease Intervention/treatment Phase
Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome (MODS) Drug: Anakinra Drug: Placebo Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, adaptively-randomized, double-blind, placebo controlled clinical trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS (TRIPS)
Estimated Study Start Date : May 15, 2022
Estimated Primary Completion Date : May 15, 2027
Estimated Study Completion Date : August 31, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis
Drug Information available for: Anakinra

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05267821


Contacts
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Contact: Mark Hall, MD 6147223438 mark.hall@nationwidechildrens.org

Locations
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Sponsors and Collaborators
Nationwide Children's Hospital
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Responsible Party: Mark Hall, Chief, Division of Critical Care Medicine, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT05267821    
Other Study ID Numbers: TRIPS
First Posted: March 4, 2022    Key Record Dates
Last Update Posted: May 10, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sepsis
Toxemia
Inflammation
Multiple Organ Failure
Pathologic Processes
Infections
Systemic Inflammatory Response Syndrome
Shock
Interleukin 1 Receptor Antagonist Protein
Antirheumatic Agents