Mycobacterium w in Patients With Severe Sepsis

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

202

Participants

Timeline

Start Date

January 31, 2016

Primary Completion Date

October 31, 2018

Study Completion Date

October 31, 2018

Conditions
Sepsis
Interventions
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

Trial Locations (1)

160012

Department of Pulmonary Medicine, Chandigarh

All Listed Sponsors
collaborator

Pandit Bhagwat Dayal Sharma, PGIMS, Rohtak

OTHER

collaborator

St.John's National Academy of Health Sciences

OTHER

lead

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

NCT02330432 - Mycobacterium w in Patients With Severe Sepsis | Biotech Hunter | Biotech Hunter