Transcriptional profiling of whole blood leukocytes obtained from critically ill patients with sepsis treated with clarithromycin, or not, and healthy particpants

To evaluate whether clarithromycin improves 28-day mortality among patients with sepsis, respiratory and multiple-organ dysfunction syndrome. The INntravenous CLArithromycin in Sepsis and multiple organ dysfunction Syndrome trial was a phase 3, randomized, double blind, placebo-controlled clinical study, conducted in 11 intensive care units and 2 Internal Medicine wards in 2 countries. Patients with sepsis, respiratory failure and total sequential organ failure assessment score of =7 were enrolled between December 2017 and September 2019. Follow-up lasted 90 days. Patients were randomized to receive 1 gr of intravenous clarithromycin or placebo once daily for 4 consecutive days. Overall design: Examination of PAXgene blood leukocyte RNA expression in critically-ill patients due to sepsis treated with clarithromycin after the first day of study inclusion (INC_D1_A) and in the same patients after five days (INC_D5_A). Placebo-treated patients after one day of study inclusion (INC_D1_B) and same patients treated with placebo after five days (INC_D5_B). Healthy pariticpants were also included and assessed (healthy).