drugset / Trial / NCT00252915
Reconstruction of Monocytic Immunocompetence by Granulocyte-macrophage-colony Stimulating Factor (GM-CSF) in Patients With Severe Sepsis and Septic Shock
Phase 2
Completed
38 enrolled
Charite University, Berlin, Germany
German Research Foundation · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
There is basic science evidence that GM-CSF reconstructs cellular immunity in septic patients. In this prospective, randomised double-blind, placebo-controlled trial, we investigate whether this can be achieved in patients with severe sepsis and septic shock.
Timeline
- Start
- 2005-11
- Primary completion
- 2007-01
- Completion
- 2007-04
Outcome
Met primary endpoint
paper After GM-CSF treatment, mHLA-DR was normalized in 19/19 treated patients, whereas this occurred in 3/19 control subjects only (P < 0.001). PMID 19590022 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GM-CSF | Protein / enzyme biologic | 4 ug/kg | — |