drugset / Trial / NCT01495637
GM-CSF for Immunomodulation Following Trauma (GIFT) Study
Phase 4
Completed
108 enrolled
Mark Hall
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collabNational Institute of General Medical Sciences (NIGMS) · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2011-12
- Primary completion
- 2022-02
- Completion
- 2023-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | sargramostim | Protein / enzyme biologic | 30 ug/m2 | Intravenous |
| Subject | sargramostim | Protein / enzyme biologic | 62 ug/m2 | Intravenous |
| Subject | sargramostim | Protein / enzyme biologic | 125 ug/m2 | Intravenous |