drugset / Trial / NCT02330432
Mycobacterium w in Patients With Severe Sepsis
Phase 2/3
Completed
202 enrolled
Post Graduate Institute of Medical Education and Research, Chandigarh
Pandit Bhagwat Dayal Sharma, PGIMS, Rohtak · collabSt.John's National Academy of Health Sciences · collab
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2016-01
- Primary completion
- 2018-10-31
- Completion
- 2018-10-31
Publications
- Results 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mycobacterium w | Vaccine | 0.3 ml | Other |