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Published on: March 24, 2017
A randomized trial of Mycobacterium w in severe sepsis
Inderpaul Singh Sehgal1, Ritesh Agarwal1, Ashutosh N Aggarwal1
1Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
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.
Insights
Mycobacterium w (Mw) treatment in severe sepsis reduced mechanical ventilation days and hospital stays. This immunomodulator also lowered infection rates and improved organ function scores.
Area of Science:
- Immunology
- Critical Care Medicine
- Infectious Diseases
Background:
- Severe sepsis is a life-threatening condition with high mortality and morbidity.
- Current treatments for severe sepsis focus on supportive care and antimicrobial therapy.
- There is a need for adjunctive therapies to improve outcomes in severe sepsis.
Purpose of the Study:
- To evaluate the efficacy of Mycobacterium w (Mw), an immunomodulator, as an adjunctive treatment in patients with severe sepsis.
- To assess Mw's impact on mortality, mechanical ventilation duration, length of hospital and ICU stay, and organ function.
- To determine the effect of Mw on the incidence of secondary bacterial infections.
Main Methods:
- A randomized controlled trial was conducted involving patients aged 18 years or older with severe sepsis.
- Patients received either intradermal Mycobacterium w (Mw) or a saline placebo within 48 hours of the onset of organ dysfunction.
- Primary endpoint was 28-day mortality; secondary endpoints included ventilator days, ICU and hospital length of stay, and changes in Sequential Organ Failure Assessment (SOFA) scores.
Main Results:
- No significant difference in 28-day mortality was observed between the Mw and control groups (7 vs 8 deaths).
- The Mycobacterium w (Mw) group showed a significant reduction in mechanical ventilator days (median 6 vs 9 days; P=0.025).
- Mw treatment led to significantly shorter ICU (median 7 vs 12 days; P=0.006) and hospital stays (median 10 vs 16 days; P=0.007), a higher delta SOFA score (P=0.027), and a lower incidence of secondary bacterial infections (P=0.009).
Conclusions:
- Mycobacterium w (Mw) administration in severe sepsis is associated with improved clinical outcomes.
- Mw significantly reduces the duration of mechanical ventilation and length of hospital and ICU stays.
- The use of Mw also correlates with a lower incidence of nosocomial infections and improved organ function as indicated by SOFA scores.
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