Mycobacterium w in Patients With Severe Sepsis

Phase IIb Randomized, Double Blind, Two Arm, Controlled Clinical Trial of Mycobacterium W in Combination With Standard Therapy Versus Standard Therapy Alone in Sepsis

Recent evidence suggests that sepsis continuum includes an immune paralytic state, which may play a significant role in sepsis. Mycobacterium w by its TLR4 agonist activity may help in restoring immunity, thereby improving outcomes in patients with severe sepsis.

In this randomized trial, the investigators propose to evaluate the efficacy of Mw in patients with severe sepsis.

Inclusion Criteria:

Patients with severe sepsis within 48 hours of first organ dysfunction

• Cardiovascular system dysfunction: systolic blood pressure ≤90 mm Hg or the mean arterial pressure ≤70 mm Hg for at least one hour despite adequate fluid resuscitation or the use of vasopressors to maintain a systolic blood pressure or mean arterial pressure of >90 and >65 mm Hg, respectively
• Renal dysfunction: urine output <0.5 ml/kg/hour for two consecutive hours despite adequate fluid resuscitation
• Respiratory system dysfunction: PaO2/FiO2 ≤300 or ≤250 if lung sepsis
• Hematologic dysfunction: platelet count <100,000/mm3 or decrease by 50% in the three days preceding enrollment
• Unexplained metabolic acidosis: pH ≤7.30

Exclusion Criteria:

• Pregnancy
• Gram-positive culture
• Only fungal infection as source of sepsis
• Patients who received cardiopulmonary resuscitation
• Those on immunosuppressive therapy
• Those unwilling to provide informed consent