Trial record 1 of 1 for:
05266001
GM-CSF for Reversal of Immunoparalysis in Pediatric Sepsis-induced MODS (GRACE-2)
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| ClinicalTrials.gov Identifier: NCT05266001 |
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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 GRACE-2 study is a prospective, multi-center, double-blind, randomized controlled trial of the drug GM-CSF vs placebo in children with sepsis-induced multiple organ dysfunction syndrome (MODS) who have immunoparalysis with mild to moderate inflammation.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome | Drug: GM-CSF Other: Placebo | Phase 3 |
The GRACE-2 study is a is a prospective, multi-center, double-blind, randomized controlled trial of the drug GM-CSF vs placebo in children with sepsis-induced multiple organ dysfunction syndrome (MODS) who have immunoparalysis with mild to moderate inflammation. Eligible subjects will undergo centralized immunophenotyping on MODS Day 2. Those who are found to have immunoparalysis (a whole blood LPS-induced TNF-alpha production capacity < 200 pg/ml) with mild to moderate inflammation (serum ferritin level < 2000 ng/ml) will be randomized to receive intravenous (IV) GM-CSF at a dose of 125 mcg/m2/day x 7 days or placebo. The primary outcome variable is the cumulative 28-day Pediatric Logistic Organ Dysfunction (PELOD)-2 score. Secondary outcomes include measures of health-related quality of life and function status at 3 months from randomization.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 400 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Prospective, randomized, double-blind, placebo-controlled clinical trial |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | GM-CSF for Reversal of Immunoparalysis in Pediatric Sepsis-induced MODS |
| Actual Study Start Date : | June 14, 2022 |
| Estimated Primary Completion Date : | May 31, 2027 |
| Estimated Study Completion Date : | August 31, 2027 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: GM-CSF
Intravenous GM-CSF 125 mcg/m2/day x 7 days
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Drug: GM-CSF
same as arm/group description |
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Placebo Comparator: Placebo
Intravenous placebo x 7 days
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Other: Placebo
same as arm/group description |
Primary Outcome Measures :
- Cumulative 28-day Pediatric Logistic Organ Dysfunction (PELOD)-2 score [ Time Frame: 28 days from randomization ]Cumulative Pediatric Logistic Organ Dysfunction (PELOD)-2 score through 28 days post-randomization. The range of PELOD-2 score for a given day is 0 - 33 with a higher number being worse.
Secondary Outcome Measures :
- 3-month health-related quality of life [ Time Frame: 3 months post-randomization ]Change in Pediatric Quality of Life inventory (PedsQL) score from baseline to 3 months post-randomization. The range of PedsQL scores is from 0 - 100, with higher values corresponding to better quality of life.
- 3-month functional status [ Time Frame: 3 months post-randomization ]Change in Functional Status Score from baseline to 3 months post-randomization. The range of possible FSS score for a given subject is 6 - 30 with a higher score indicating worse function.
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 therapy OR receipt of myeloablative therapy within the previous 14 days; OR
- Known allergy to GM-CSF; 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 GRACE-2 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): NCT05266001
Contacts
| Contact: Mark W 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)
| Responsible Party: | Mark Hall, Chief, Critical Care Medicine, Nationwide Children's Hospital |
| ClinicalTrials.gov Identifier: | NCT05266001 |
| Other Study ID Numbers: |
GRACE-2 |
| 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 Multiple Organ Failure Infections |
Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Shock |