Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Pandit Bhagwat Dayal Sharma, PGIMS, Rohtak | OTHER |
| St.John's National Academy of Health Sciences | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mycobacterium w group | Experimental | Patients in the experimental arm (Mw) in addition to standard care will receive single daily dose of 0.3 mL of Mw (heat-inactivated Mw [0.5 × 10^9]; Cadila Pharma, Ahmedabad, India) in the deltoid region for 3 consecutive days |
|
| Best standard care | Active Comparator | Best standard care for sepsis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mycobacterium w | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | 28-day all-cause mortality | 28-day |
| Measure | Description | Time Frame |
|---|---|---|
| New onset organ dysfunction measured by delta SOFA (maximum minus baseline SOFA) | Measured by delta SOFA (maximum minus baseline SOFA) | 28-day |
| Ventilator-free days | Day off the mechanical ventilator |
Not provided
Inclusion Criteria:
Patients with severe sepsis within 48 hours of first organ dysfunction
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pulmonary Medicine | Chandigarh | Uttarakhand | 160012 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25241089 | Result | Sehgal IS, Agarwal R, Aggarwal AN, Jindal SK. A randomized trial of Mycobacterium w in severe sepsis. J Crit Care. 2015 Feb;30(1):85-9. doi: 10.1016/j.jcrc.2014.08.012. Epub 2014 Aug 28. | |
| 33852919 | Derived | Sehgal IS, Basumatary NM, Dhooria S, Prasad KT, Muthu V, Aggarwal AN, Pal A, Desai M, Chaudhry D, Supe PD, Kurmi P, Choudhuri R, Shah C, Agarwal R. A Randomized Trial of Mycobacterium w in Severe Presumed Gram-Negative Sepsis. Chest. 2021 Oct;160(4):1282-1291. doi: 10.1016/j.chest.2021.03.062. Epub 2021 May 7. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| C080550 | Mycobacterium w vaccine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Best standard care | Other | 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 |
|
| 28-day |
| Time-to-vasopressor withdrawal | 28-day |
| ICU length of stay | 28-day |
| Hospital length of stay | 28-day |
| New-onset infection | 28-day |
| D013568 |
| Pathological Conditions, Signs and Symptoms |