Accumulating knowledge suggests that there is a spectrum of dysregulation in the inflammatory response to infection in sepsis patients. On the one end of this spectrum there are patients whose immune response is characterized by fulminant hyper-inflammation. On the other end of this spectrum there are patients whose immune response is characterized by immunoparalysis. The majority of patients are between these two extremes. The primary hypothesis of the ImmunoSep trial is to administer adjunctive therapy in a personalized manner aiming to modulate specifically the sepsis-associated hyper-inflammation or immunoparalysis. It is anticipated that with this strategy patients' organ dysfunctions be improved.
ImmunoSep is a randomized placebo-controlled phase 2 clinical trial with a double-dummy design where the effect of personalized immunotherapy in patients with sepsis and either fulminant hyper-inflammation or immunoparalysis is studied. The Department of Anesthesiology and Intensive Care Medicine of the Jena University Hospital participates in this trial as a study center. Further information about this trial can be found at: www.immunosep.eu.
ClinicalTrials.gov Identifier: NCT04990232