Mycobacterium w in Patients With Severe Sepsis

Sepsis Clinical Trial

— MISS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02330432
• Other study ID #: Pulm/Mw/002
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: January 2016
• Est. completion date: October 31, 2018

Study information

• Verified date: February 2021
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: October 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

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

Locations

Country	Name	City	State
India	Department of Pulmonary Medicine	Chandigarh	UT

Sponsors (3)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research	Pandit Bhagwat Dayal Sharma, PGIMS, Rohtak, St.John's National Academy of Health Sciences

Country where clinical trial is conducted

India, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	28-day all-cause mortality	28-day
Secondary	New onset organ dysfunction measured by delta SOFA (maximum minus baseline SOFA)	Measured by delta SOFA (maximum minus baseline SOFA)	28-day
Secondary	Ventilator-free days	Day off the mechanical ventilator	28-day
Secondary	Time-to-vasopressor withdrawal		28-day
Secondary	ICU length of stay		28-day
Secondary	Hospital length of stay		28-day
Secondary	New-onset infection		28-day