NCT02330432

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Sepsis

Interventions

Type	Name	Description
BIOLOGICAL	Mycobacterium w	Single daily dose of 0.3 mL of Mw (heat-inactivated Mw \[0.5 × 10\^9\]; Immuvac, Cadila Pharma, Ahmedabad, India) in the deltoid region for 3 consecutive days
OTHER	Best standard care	Antibiotics as early as possible; Norepinephrine \> vasopressin \> epinephrine for hypotension; Blood glucose 140-180 mg/dL; DVT and stress ulcer prophylaxis; Low tidal volume mechanical ventilation; Standard VAP, CLABSI prevention bundles

Timeline

• Start date: 2016-01-01
• Primary completion: 2018-10-31
• Completion: 2018-10-31
• First posted: 2015-01-05
• Last updated: 2021-02-23

Locations

1 site across 1 country: India