GM-CSF for Reversal of immunopAralysis in pediatriC sEpsis-induced MODS Study



Status:Recruiting
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:Any - 17
Updated:12/12/2018
Start Date:December 5, 2018
End Date:December 5, 2021
Contact:Mark W Hall, MD
Email:mark.hall@nationwidechildrens.org
Phone:614-722-3438

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GM-CSF for Reversal of immunopAralysis in pediatriC sEpsis-induced MODS (GRACE)

This study is an open-label, multi-center, interventional trial in which children with
sepsis-induced MODS undergo surveillance immune function testing beginning on Day 2 of MODS.
Those children who demonstrate immunoparalysis (TNF-alpha response <200 pg/ml) will receive a
7-day course of GM-CSF at a dose of 125 or 250 mcg/m2/day by either the intravenous (IV) or
subcutaneous (SQ) route.

The goal of the study is to establish the dose and route of delivery that results in
resolution of immunoparalysis (TNF-alpha response >=200 pg/ml) by the morning after the 3rd
scheduled dose with persistent resolution of immunoparalysis on the morning after the 7th
scheduled dose. Resolution of immunoparalysis in 8 out of the first 10 subjects in a study
treatment arm represents a successful dose and route. The goal of this study will be achieved
through the following Specific Aims:

Specific Aim 1. Establish the immunologic efficacy of GM-CSF administered by the IV and SQ
routes in children with immunoparalysis in the setting of sepsis-induced MODS.

Specific Aim 2. Estimate the pharmacokinetic parameters by the IV and SQ GM-CSF administered
in pediatric sepsis-induced MODS.

Specific Aim 3. Demonstrate the feasibility of screening, enrollment, drug delivery, and
sample collection for a multi-center immunostimulation trial in children with sepsis-induced
MODS.


Inclusion Criteria:

- >= 40 weeks gestational age to <18 years; AND

- Onset of >=2 new organ dysfunctions (compared to pre-sepsis baseline) as measured by
the Proulx criteria; AND

- Documented or suspected infection as the MODS inciting event.

Exclusion Criteria:

- Unable to collect a cumulative total of 20.5 mL of blood for this study due to
research blood draw limits; OR

- Limitation of care order at the time of screening; OR

- Patients at high risk for brain death; OR

- Active (or planned within 7 days) immunosuppressive treatment for oncologic,
transplant, or rheumatologic disease; OR

- Known primary immunodeficiency disorder; OR

- Diagnosis of myeloid leukemia, myelodysplasia, or autoimmune thrombocytopenia;OR

- Known allergy to GM-CSF; OR

- Documented hyperferritinemia (serum ferritin >= 500 ng/ml) during current sepsis
event; OR

- Contraindication to SQ injection (ECMO); OR

- Burns where >5% of the total body surface area is affected; OR

- Renal replacement therapy at the time of screening; OR

- On ECMO or anticipated to require ECMO; OR

- Known pregnancy; OR

- Inability to collect and ship sample for immune testing on MODS Day 2; OR

- Previous enrollment in the GRACE study
We found this trial at
8
sites
3414 Fifth Avenue
Pittsburgh, Pennsylvania 15213
Phone: 412-692-5325
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Phone: 614-722-3438
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Phone: 800-879-2467
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Phone: 720-777-1234
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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3901 Beaubien St
Detroit, Michigan 48201
(313) 745-5437
Phone: 313-745-5437
Children's Hospital of Michigan Since 1886, the Children's Hospital of Michigan has been dedicated to...
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Los Angeles, California 90095
Phone: 310-206-4730
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San Francisco, California 94107
Phone: 415-476-9000
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111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Phone: 202-476-5000
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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