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Cytokine

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

Q: 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.

Q: 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.

Q: 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.

Q: 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.

Q: Are there different hospitals testing this procedure in urban areas?

Children's Hospital of Pittsburgh in <a href="https://www.withpower.com/clinical-trials/pennsylvania">Pennsylvania</a>, Rainbow Babies and Children's Hospital in Cleveland, <a href="https://www.withpower.com/clinical-trials/ohio">Ohio</a>, Medical University of <a href="https://www.withpower.com/clinical-trials/south-carolina">South carolina</a> in Charleston, South Carolina are <a href="https://www.withpower.com/clinical-trials/all">all</a> participating locations for this study. There are also 26 other sites where patients can be enrolled.

Q: 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 &#x3C; 18 years; Admission to the PICU or CICU; Onset of ≥ 2 new organ dysfunctions within the last 3 calendar days (compared to pre-<a href="https://www.withpower.com/clinical-trials/sepsis">sepsis</a> baseline) as measured by the modified Proulx criteria; Documented or suspected infection as the MODS inciting event.

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

Timeline

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

Select...

I have or might have an infection that led to my multiple organ dysfunction syndrome.

Select...

I am older than 40 weeks corrected gestational age but younger than 18 years.

GRACE-2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months post-randomization

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Nationwide Children's HospitalLead Sponsor

341 Previous Clinical Trials

5,220,106 Total Patients Enrolled

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH

1,965 Previous Clinical Trials

2,672,397 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

Recent research and studies

clinicaltrials.govStudy

GM-CSF for Reversal of Immunoparalysis in Pediatric Sepsis-induced MODS

Mark Hall 2022. "GM-CSF for Reversal of Immunoparalysis in Pediatric Sepsis-induced MODS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05266001.

All > Sepsis