GM-CSF for Immunomodulation Following Trauma (GIFT) Study
Status:
Active, not recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
The GIFT study is a prospective, multi-center, 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 dose-finding phase
is the current active phase of the study. 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.
Phase:
Phase 4
Details
Lead Sponsor:
Mark Hall
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institute of General Medical Sciences (NIGMS)