NCT03769844View on ClinicalTrials.gov

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

PHASE4Active, not recruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

December 5, 2018

Primary Completion Date

December 5, 2023

Study Completion Date

December 5, 2023

Conditions
Pediatric Sepsis-induced MODS
Interventions
DRUG

GM-CSF

Subjects demonstrating immunoparalysis (defined by a whole blood ex vivo LP-induced TNF-alpha production capacity \< 200 pg/ml) will receive 7 days of GM-CSF treatment by either the IV or SQ route at a dose of either 125 or 250 mcg/m2/day for 7 days.

Trial Locations (8)

15224

Children's Hospital of Pittsburgh, Pittsburgh

19104

Children's Hospital of Philadelphia, Philadelphia

20010

Children's National Medical Center, Washington D.C.

43205

Nationwide Children's Hospital, Columbus

48201

Children's Hospital of Michigan, Detroit

80045

Children's Hospital of Colorado, Aurora

90095

UCLA Mattel Children's Hospital, Los Angeles

94158

Benioff Children's Hospital/UCSF, San Francisco

All Listed Sponsors
lead

Nationwide Children's Hospital

OTHER