Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS (TRIPS)
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| ClinicalTrials.gov Identifier: NCT05267821 |
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Recruitment Status :
Recruiting
First Posted : March 4, 2022
Last Update Posted : February 8, 2023
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Sponsor:
Nationwide Children's Hospital
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Mark Hall, Nationwide Children's Hospital
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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 |
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 (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) |
| Actual Study Start Date : | June 14, 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 |
|---|---|
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Active Comparator: Anakinra 4 mg/kg/day
IV Anakinra 4mg/kg/day x 7 days
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Drug: Anakinra
See information in arm/group descriptions |
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Active Comparator: Anakinra 8 mg/kg/day
IV Anakinra 8 mg/kg/day x 7 days
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Drug: Anakinra
See information in arm/group descriptions |
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Active Comparator: Anakinra 12 mg/kg/day
IV Anakinra 12 mg/kg/day x 7 days
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Drug: Anakinra
See information in arm/group descriptions |
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Active Comparator: Anakinra 16 mg/kg/day
IV Anakinra 16 mg/kg/day x 7 days
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Drug: Anakinra
See information in arm/group descriptions |
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Placebo Comparator: Placebo
IV placebo x 7 days
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Drug: Placebo
See information in arm/group descriptions |
Primary Outcome Measures :
- 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 :
- 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-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
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| Ages Eligible for Study: | 1 Day 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
| Contact: Mark Hall, MD | 6147223438 | mark.hall@nationwidechildrens.org |
Locations
Show 24 study locations
Sponsors and Collaborators
Nationwide Children's Hospital
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
| 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: | February 8, 2023 |
| Last Verified: | February 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| 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 |