Clinical trial NCT02330432: Mycobacterium w in Patients With Severe Sepsis
Official title: Phase IIb Randomized, Double Blind, Two Arm, Controlled Clinical Trial of Mycobacterium W in Combination With Standard Therapy Versus Standard Therapy Alone in Sepsis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Sepsis
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
Collaborators: name: Pandit Bhagwat Dayal Sharma, PGIMS, Rohtak
name: St.John's National Academy of Health Sciences
First posted: 2015-01-05
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

Patients with severe sepsis within 48 hours of first organ dysfunction

* Cardiovascular system dysfunction: systolic blood pressure ≤90 mm Hg or the mean arterial pressure ≤70 mm Hg for at least one hour despite adequate fluid resuscitation or the use of vasopressors to maintain a systolic blood pressure or mean arterial pressure of \>90 and \>65 mm Hg, respectively
* Renal dysfunction: urine output \<0.5 ml/kg/hour for two consecutive hours despite adequate fluid resuscitation
* Respiratory system dysfunction: PaO2/FiO2 ≤300 or ≤250 if lung sepsis
* Hematologic dysfunction: platelet count \<100,000/mm3 or decrease by 50% in the three days preceding enrollment
* Unexplained metabolic acidosis: pH ≤7.30

Exclusion Criteria:

* Pregnancy
* Gram-positive culture
* Only fungal infection as source of sepsis
* Patients who received cardiopulmonary resuscitation
* Those on immunosuppressive therapy
* Those unwilling to provide informed consent

Primary outcomes:
measure: Mortality
timeFrame: 28-day
Secondary outcomes:
measure: New onset organ dysfunction measured by delta SOFA (maximum minus baseline SOFA)
timeFrame: 28-day
measure: Ventilator-free days
timeFrame: 28-day
measure: Time-to-vasopressor withdrawal
timeFrame: 28-day
measure: ICU length of stay
timeFrame: 28-day
measure: Hospital length of stay
timeFrame: 28-day
measure: New-onset infection
timeFrame: 28-day
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Department of Pulmonary Medicine
state: UT
Study officials:
References:
citation: 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.
citation: 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.