GM-CSF for Immunomodulation Following Trauma (GIFT) Study
The GIFT study is an interventional trial using the drug GM-CSF for the reversal of innate immune suppression in critically injured children. The study will be conducted in two phases, a dose-finding phase then an efficacy phase. The central hypothesis of the study is that immunomodulation with GM-CSF will result in reduction in the risk of nosocomial infection after critical injury in high-risk children through safe, rapid, and sustained improvement in innate immune function.
Critical Injury (Trauma) in Children
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||GM-CSF for Immunomodulation Following Trauma (GIFT) Study|
- Nosocomial infection [ Time Frame: 14-days post-trauma ] [ Designated as safety issue: Yes ]
- Innate immune function [ Time Frame: Day 4 post-trauma ] [ Designated as safety issue: No ]To identify the lowest immunostimulatory yet tolerable dose of GM-CSF that produces lasting improvement in innate immune function in treated children.
- Nosocomial infection [ Time Frame: 28-days post-trauma ] [ Designated as safety issue: Yes ]
- Innate Immune Function [ Time Frame: Day 14 post-trauma ] [ Designated as safety issue: No ]To identify the lowest immunostimulatory yet tolerable dose of GM-CSF that produces lasting improvement in innate immune function in treated children.
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
|Active Comparator: GM-CSF||
GM-CSF is to be administered IV on post-trauma days 1, 2, and 3 at a dose of 30, 62, or 125 mcg/m2 per day.
|Placebo Comparator: placebo||
placebo will be administered on post-trauma days 1, 2, and 3
Please refer to this study by its ClinicalTrials.gov identifier: NCT01495637
|Contact: Mark W Hall, MD||614-722-3438||Mark.Hall@NationwideChildrens.org|
|United States, Ohio|
|Nationwide Children's Hospital||Recruiting|
|Columbus, Ohio, United States, 43205|
|Contact: Mark W Hall, MD 614-722-3438 Mark.Hall@NationwideChildrens.org|
|Principal Investigator:||Mark W Hall, MD||Nationwide Children's Hospital|