Post Marketing Surveillance of inj. Sepsivac® (Mycobacterium w) to evaluate safety and efficacy in combination with standard therapy in gram negative bacterial sepsis

Sepsis is a life-threatening organ dysfunction caused by a dysregulated response of the host to an infection. This definition is fully recognizing two crucial elements in pathogenesis: the infection and the dysregulated host response. Sepsis remains an important and life-threatening problem and the most common cause of death in the ICU with mortality between 20 to 50% for sepsis and 45 to 80% for septic shock.  Mycobacterium w (Mw) is a nonpathogenic, rapidly growing atypical mycobacterium classifiable in Runyon group IV. It shares T and B cell determinants with Mycobacterium leprae and Mycobacterium tuberculosis. When heat-inactivated and administered intradermally, it works as a poly TLR antagonist (TLR – 4, 5, 7, 9), MAPK modulator, cytokine suppressor, inhibitor of cytokine - induced NO release and it reverses LPS induced events. In a gene expression profile, it was observed that the genes that are modulated in sepsis get REVERSE modulated by Mw stimulation, indicating that Mw may/shall work in treatment of sepsis. Mw has been subjected to extensive toxicological studies as per the guidelines of Indian Council of Medical Research (ICMR) in 2 species of animals and has been adjudged safe and devoid of toxicity. In other experiments, administration of large doses of live Mw, by various routes did not cause any mortality in mice and guinea pigs, confirming the non-pathogenic nature of the bacillus. Aims of the study is to evaluate the safety and efficacy of Sepsivac® (Mycobacterium W) along with standard of care treatment in patients with sepsis. Study will be conducted on minimum 200 patients diagnosed to have sepsis due to gram negative bacteria with acute increase of ⩾2 SOFA points. After obtaining informed consent, each patient will receive Inj. Sepsivac®.  The patients will be administered the study medication Inj. Sepsivac® (Mycobacterium w) intradermally along with standard of care therapy. 0.3 ml/day of Inj. Sepsivac® will be administered as intra-dermal injections for three consecutive days as 0.1ml x 3 injections at different sites. Primary objective is to assess the safety of Inj. Sepsivac® in the patients of sepsis and Secondary objectives is to assess the efficacy of Inj. Sepsivac® in the patients of sepsis.