Severe Sepsis With Septic Shock Clinical Trial
Official title:
A Multicenter, Randomized, Double-blinded, Placebo-controlled Study of Two Dosing Frequencies of Recombinant Interleukin-7 (CYT107) Treatment to Restore Absolute Lymphocyte Counts in Sepsis Patients.
A multicenter, randomized, double-blinded, placebo-controlled study of two dosing frequencies
of recombinant Interleukin-7 (CYT107) treatment to restore absolute lymphocyte counts in
sepsis patients; IRIS-7B (Immune Reconstitution of Immunosuppressed Sepsis patients).
A parallel study will be performed in France to allow a common statistical analysis of the
primary end points and analysis for the enrolled patient population.
Sepsis is the leading cause of death in critically ill patients in most intensive care units
in Europe and the US. Recently, evidence has accumulated that sepsis progresses from a state
of hyper-inflammation to a state of immunosuppression. This immunosuppressive phase is
characterized by increased incidence of secondary infections often with relatively avirulent
opportunistic type pathogens. Currently, new therapeutic approaches to sepsis are occurring
using immuno-adjuvants that boost host immunity. One of the most promising agents
Interleukin-7 is an essential, non-redundant, pluripotent cytokine produced mainly by bone
marrow and thymic stromal cells that is required for T-cell survival.In addition to its
anti-apoptotic properties, IL-7 induces potent proliferation of naïve and memory T-cells
potentially supporting replenishment of the peripheral T-cell pool which is severely depleted
during sepsis. These effects were confirmed in clinical trials at the National Cancer
Institute and in HIV+ patients.
This clinical study will test the ability of IL-7 to restore the absolute lymphocyte counts
in septic patients who have markedly reduced levels of circulating lymphocytes. An effect
already confirmed in preclinical models of sepsis.
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