Department of Pulmonary Medicine
Chandigarh, Uttarakhand, 160012, India
NCT Number: NCT02330432
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.
Looking for future studies?
Notify Me18 year–65 year
All sexes
Interventional
Phase 2 / Phase 3
Chandigarh, Uttarakhand, 160012, India
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients with severe sepsis within 48 hours of first organ dysfunction
Exclusion criteria
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
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
Time frame: 28-day
28-day all-cause mortality
Time frame: 28-day
Measured by delta SOFA (maximum minus baseline SOFA)
Time frame: 28-day
Day off the mechanical ventilator
Time frame: 28-day
Time frame: 28-day
Time frame: 28-day
Time frame: 28-day
Post Graduate Institute of Medical Education and Research, Chandigarh
Other
Phase IIb Randomized, Double Blind, Two Arm, Controlled Clinical Trial of Mycobacterium W in Combination With Standard Therapy Versus Standard Therapy Alone in Sepsis
Acronym: MISS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06541600
Infections, Inflammation
Wuhan, Hubei, China
View Trial DetailsNCT06080282
Infections, Inflammation
Wuhan, Hubei, China
View Trial DetailsNCT07025096
Acute Respiratory Distress Syndrome (ARDS), Infections
Philadelphia, Pennsylvania, United States
View Trial DetailsNCT06876168
Acute Respiratory Failure, Infections
Lexington, Kentucky, United States
View Trial Details