Sepsis is a severe disease with a high mortality rate and lack of efficacious therapies.
Proton pump inhibitors (PPI) are drugs widely used to inhibit acid secretion by gastric cells
and with a high safety profile. Carta and Rubartelli (IRCCS San Martino - Genova) have
recently reported that PPI, such as esomeprazole, inhibit TNF-alfa and IL-1ß secretion.
Moreover, they showed that a single administration of PPI protects mice from endotoxic shock
with no adverse effects. PPI-SEPSIS is a randomized, double blind, controlled against placebo
clinical trial to test if high-doses esomeprazole in septic patients reduces the severity of
organs failure.
In parallel, the investigators will evaluate ex vivo in monocytes from septic patients: redox
state and response to inflammatory stimuli; ATP release; metabolic changes and pH; cytokine
production; the effects of PPI on these parameters.
Phase:
Phase 3
Details
Lead Sponsor:
Università Vita-Salute San Raffaele
Collaborator:
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy