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

Phase 3
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
Screening 3 weeks
Treatment Varies
Follow Up 3 months post-randomization
Awards & highlights

GRACE-2 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.Check my eligibility
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.See study design
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.

GRACE-2 Trial Eligibility Criteria

Inclusion Criteria

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

GRACE-2 Trial 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

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

GRACE-2 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
341 Previous Clinical Trials
5,220,103 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,963 Previous Clinical Trials
2,674,341 Total Patients Enrolled

Media Library

GM-CSF (Cytokine) Clinical Trial Eligibility Overview. Trial Name: NCT05266001 — Phase 3
Sepsis-induced Multiple Organ Dysfunction Syndrome Research Study Groups: GM-CSF, Placebo
Sepsis-induced Multiple Organ Dysfunction Syndrome 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are you looking for more participants at the moment?

"From the information available on clinicaltrials.gov, it appears that this particular trial is actively recruiting patients. The listing was first posted on June 14th, 2022 and has since been updated on November 15th of the same year."

Answered by AI

Are individuals above the age of 75 accepted in this trial?

"Children that are less than a day old up to adolescents aged 17 qualify for this trial, of which there are 40. In contrast, there are 153 studies for patients over the age of 65."

Answered by AI

How many patients will be involved in this clinical trial at most?

"That is correct. The clinicaltrials.gov website has information indicating that this trial, which was first posted on 6/14/2022, is actively recruiting patients. 400 individuals are needed for the study and there are 26 sites where people can participate."

Answered by AI

Does GM-CSF have any dangerous side effects?

"We believe that GM-CSF is safe based on the amount of data supporting its efficacy and safety from Phase 3 trials."

Answered by AI

Are there different hospitals testing this procedure in urban areas?

"Children's Hospital of Pittsburgh in Pennsylvania, Rainbow Babies and Children's Hospital in Cleveland, Ohio, Medical University of South carolina in Charleston, South Carolina are all participating locations for this study. There are also 26 other sites where patients can be enrolled."

Answered by AI

Which patients would most likely benefit from participating in this clinical trial?

"Eligible participants for this study include 400 people with septicemia that meet the following age, organ function, and infection criteria: ≥ 40 weeks corrected gestational age to < 18 years; Admission to the PICU or CICU; Onset of ≥ 2 new organ dysfunctions within the last 3 calendar days (compared to pre-sepsis baseline) as measured by the modified Proulx criteria; Documented or suspected infection as the MODS inciting event."

Answered by AI
~251 spots leftby May 2027