At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Personalized Randomized Trial of Validation and Restoration of Immune Dysfunction in Severe Infections and Sepsis
In Brief
A Phase 2 clinical trial evaluating Anakinra, Recombinant human interferon-gamma, and 1 other intervention for Sepsis and Macrophage Activation Syndrome. Completed, enrolled 36 participants across 13 sites.
Detailed Summary
The aim of the study is to conduct one RCT of personalized immunotherapy in sepsis targeting patients who lie either on the predominantly hyper-inflammatory arm or on the predominantly hypo-inflammatory arm of the spectrum of the host response. These patients will be selected by the use of a panel of biomarkers and laboratory findings and they will be randomly allocated to placebo or immunotherapy treatment according to their needs.
Study Details
Timeline
Interventions
Treatment with anakinra
Treatment with recombinant human interferon-gamma
Treatment with Placebo