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Cytokine
GM-CSF for MODS (GRACE Trial)
Phase 4
Waitlist Available
Led By Mark W Hall, MD
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
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up subjects will be screened for immunoparalysis throughout their first three weeks of sepsis-induced mods
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial will help to establish the dose and route of GM-CSF delivery that is most efficacious in reversing sepsis-induced immunoparalysis in children.
Eligible Conditions
- Sepsis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ subjects will be screened for immunoparalysis throughout their first three weeks of sepsis-induced mods
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~subjects will be screened for immunoparalysis throughout their first three weeks of sepsis-induced mods
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
TNF-alpha response
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
4Treatment groups
Experimental Treatment
Group I: SQ GM-CSF 250 mcg/m2/doseExperimental Treatment1 Intervention
If the SQ 125 mcg/m2/dose arm is not successful in a cohort of subjects (or if the IV dose had to be escalated to 250 mcg/m2/dose), we will transition to 250 mcg/m2/day via the SQ route for 7 consecutive days in a subsequent cohort.
Group II: SQ GM-CSF 125 mcg/m2/doseExperimental Treatment1 Intervention
Subjects in this arm who demonstrate immunoparalysis will receive GM-CSF by the subcutaneous (SQ) route at a dose of 125 mcg/m2/day for 7 consecutive days.
Group III: IV GM-CSF 250 mcg/m2/doseExperimental Treatment1 Intervention
If the IV 125 mcg/m2/dose arm is not successful in the first cohort of subjects, we will transition to 250 mcg/m2/day via the IV route for 7 consecutive days in a subsequent cohort.
Group IV: IV GM-CSF 125 mcg/m2/doseExperimental Treatment1 Intervention
Subjects in this arm who demonstrate immunoparalysis will receive GM-CSF by the intravenous (IV) route at a dose of 125 mcg/m2/day for 7 consecutive days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GM-CSF
2011
Completed Phase 4
~1290
Find a Location
Who is running the clinical trial?
Nationwide Children's HospitalLead Sponsor
348 Previous Clinical Trials
5,227,949 Total Patients Enrolled
3 Trials studying Sepsis
9,700 Patients Enrolled for Sepsis
Mark W Hall, MDPrincipal InvestigatorNationwide Children's Hospital
1 Previous Clinical Trials
108 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a high likelihood of experiencing brain death.You have a confirmed or suspected infection that caused multiple organ dysfunction syndrome (MODS).You have a known condition that weakens your immune system.You are allergic to GM-CSF.You have a medical condition that makes it unsafe for you to receive medications through subcutaneous injection, such as being on extracorporeal membrane oxygenation (ECMO).You have burns that cover more than 5% of your body.
Research Study Groups:
This trial has the following groups:- Group 1: SQ GM-CSF 125 mcg/m2/dose
- Group 2: SQ GM-CSF 250 mcg/m2/dose
- Group 3: IV GM-CSF 125 mcg/m2/dose
- Group 4: IV GM-CSF 250 mcg/m2/dose
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.