A randomized trial of Mycobacterium w in severe sepsis.
PURPOSE: The aim of this study was to evaluate the efficacy of Mycobacterium w (Mw), an immunomodulator in severe sepsis.
METHODS: Patients 18 years or older with severe sepsis were randomized within 48 hours of first organ dysfunction to receive either intradermal Mw or saline. The primary end point was 28-day mortality, whereas the secondary end points were ventilator days, intensive care unit (ICU) and hospital length of stay, and delta Sequential Organ Failure Assessment (SOFA) score.
RESULTS: Fifty patients with severe sepsis (25 Mw, 25 control) were included in the study. There were 7 and 8 deaths in the Mw and control groups, respectively (P = 0.51). The days on mechanical ventilator were significantly lesser in the Mw group compared with control (median, 6 vs 9; P = 0.025). The median ICU and hospital length of stay was significantly less in the Mw arm (7 vs 12 days [P =0.006] and 10 vs 16 [P = 0.007], respectively). The delta SOFA score was significantly higher in the control arm (P =0.027). There was a higher incidence of secondary bacterial infections in the control group (P = 0.009).
CONCLUSION: The use of Mw in severe sepsis was associated with significant reduction in days on mechanical ventilation, ICU and hospital length of stay, lower incidence of nosocomial infection, and delta SOFA score.