Septic Shock Clinical Trial
Official title:
A Double-Blind, Randomized, Placebo-controlled Multicenter Trial of GRanulocyte-Macrophage Colony-stimulating Factor Administration to Decrease ICU Acquired Infections in Sepsis-induced ImmunoDepression
The concept of acquired immunodeficiency after a first severe infection in the ICU is widely
described in the literature. There is a dual risk: increased mortality and increased
secondary infections. Several approaches of immunostimulatory treatments have been proposed
in the literature. The treatment proposed by this study consists of the administration of
Granulocyte-macrophage colony-stimulating factor (GM-CSF), colony stimulating factor widely
used particularly in the USA where it is marketed. A phase 2 clinical trial was conducted in
Germany in 2009.
The main objective is to measure the incidence of ICU-acquired infections in 2 groups of
patients treated by GM-CSF or placebo. ICU patients at risk are defined as surviving at D3
from a severe sepsis or septic shock and presenting a sepsis associated immunodepression. The
detection of immunosuppressed patients will be achieved by measuring the HLA-DR (Human
Leucocyte Antigen DR)with a threshold of less to 8000 sites.
Our hypothesis is that the number of secondary infections (primary endpoint) will be
significantly reduced in the treated group.
n/a
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