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Cytokine

GM-CSF for Multiple Organ Failure (GRACE-2 Trial)

Phase 3
Recruiting
Research Sponsored by Nationwide Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Documented or suspected infection as the MODS inciting event
≥ 40 weeks corrected gestational age to < 18 years
Must not have
Current or prior diagnosis of hemophagocytic lymphohistiocytosis or macrophage activation syndrome
Lactating females
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months post-randomization
Awards & highlights
Pivotal Trial

Summary

This trial is testing if the drug GM-CSF can help children with sepsis-induced multiple organ dysfunction syndrome who have immunoparalysis with mild to moderate inflammation.

Who is the study for?
This trial is for children with sepsis-induced organ dysfunction who are between 40 weeks corrected gestational age and under 18 years old. They must have new organ issues due to sepsis, be in pediatric or cardiac intensive care, and not have certain conditions like allergies to GM-CSF, high risk of brain death, severe blood disorders, or a history of specific immune diseases.
What is being tested?
The GRACE-2 study tests if GM-CSF can help kids with sepsis-induced multiple organ failure whose immune systems are too weak. It's a blind test where neither doctors nor patients know who gets the real drug versus a placebo. Kids are chosen randomly to get one or the other.
What are the potential side effects?
GM-CSF might cause allergic reactions, bone pain, fever, muscle aches, fatigue and at times may affect blood pressure or heart rate. The severity of side effects varies from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have or might have an infection that led to my multiple organ dysfunction syndrome.
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I am older than 40 weeks corrected gestational age but younger than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with HLH or MAS.
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I am currently breastfeeding.
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I have not taken anakinra or GM-CSF in the last 28 days.
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My white blood cell count is low due to recent intense therapy.
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I have a history of blood disorders like leukemia or low platelet counts due to an autoimmune condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months post-randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months post-randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cumulative 28-day Pediatric Logistic Organ Dysfunction (PELOD)-2 score
Secondary study objectives
3-month functional status
3-month health-related quality of life

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: GM-CSFActive Control1 Intervention
Intravenous GM-CSF 125 mcg/m2/day x 7 days
Group II: PlaceboPlacebo Group1 Intervention
Intravenous placebo x 7 days

Find a Location

Who is running the clinical trial?

Nationwide Children's HospitalLead Sponsor
348 Previous Clinical Trials
5,227,669 Total Patients Enrolled
3 Trials studying Sepsis
9,420 Patients Enrolled for Sepsis
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,054 Previous Clinical Trials
2,731,234 Total Patients Enrolled
18 Trials studying Sepsis
513,127 Patients Enrolled for Sepsis

Media Library

GM-CSF (Cytokine) Clinical Trial Eligibility Overview. Trial Name: NCT05266001 — Phase 3
Sepsis Research Study Groups: GM-CSF, Placebo
Sepsis Clinical Trial 2023: GM-CSF Highlights & Side Effects. Trial Name: NCT05266001 — Phase 3
GM-CSF (Cytokine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05266001 — Phase 3
~203 spots leftby May 2027
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