NCT02025660

Efficacy of Mw Vaccine in Treatment of Severe Sepsis

Does Immune-modulation Improve the Survival in Patients With Severe Sepsis? "A Proof of the Concept Study"

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Detailed description

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. The study will be conducted in the respiratory intensive care unit at PGIMER, Chandigarh, over a period of 1 year. 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 In addition to the standard therapy for sepsis, patients randomized to test arm will receive single daily dose of 0.3 ml of Mw intra-dermal for 3 consecutive days while patients randomized to control arm will receive single daily dose of 0.3 ml of Mw-placebo intra-dermal for 3 consecutive days. Study Duration Study duration for each patient will be 28 days. Follow up period is included in the study duration of 28 days Study Outlines and Timing of Visits Eligible patients will be enrolled after due consent and randomized to one of the treatment arms. The enrolled patients will be monitored for any adverse events (AEs) or serious adverse events (SAEs) throughout the study period. All patients will continue to receive standard therapy till considered requisite

Conditions

• Severe Sepsis
• Septic Shock
• Immune Modulation

Interventions

Type	Name	Description
DRUG	Mw, 0.3ml x three days sc
DRUG	Placebo

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-02-01
• Completion: 2014-03-01
• First posted: 2014-01-01
• Last updated: 2014-03-20

Locations

1 site across 1 country: India