Efficacy of Mw Vaccine in Treatment of Severe Sepsis
Status:
Completed
Trial end date:
2014-03-01
Target enrollment:
Participant gender:
Summary
Study Hypothesis Enhancement of Th-1 response with the help of a poly TLR agonist (Mw) is
likely to increase survival in patients with severe sepsis.
Objectives To study whether immunomodulation with Mycobacterium Mw helps in improving
survival and the recovery of organ function in patients with severe sepsis. This will be
assessed with the help of the following
- Mortality in the two arms
- Daily SOFA scores
- Ventilator free days
- Time-to-vasopressor withdrawal
- ICU length of stay
- Hospital length of stay METHODS This will be a proof of the concept study to assess the
effect of Mycobacterium w in combination with standard therapy versus standard therapy
alone on the inflammatory profile in sepsis due to gram negative infection. A total of
25 patients will be enrolled in each group. The patients will be randomized in balance
to receive either test drug or its placebo along with the standard of care
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Postgraduate Institute of Medical Education and Research