Mycobacterium w in Patients With Severe Sepsis (MISS)

Post Graduate Institute of Medical Education and Research, Chandigarh

Status and phase: Completed; Phase 3; Phase 2

Conditions: Sepsis

Treatments: Biological: Mycobacterium w; Other: Best standard care

Study type: Interventional

Funder types: Other

Identifiers

NCT02330432

Pulm/Mw/002

Details and patient eligibility

About

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.

Enrollment: 202 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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202 participants in 2 patient groups

Mycobacterium w group

Experimental group

Description:

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

Treatment:

Other: Best standard care

Biological: Mycobacterium w

Best standard care

Active Comparator group

Description:

Best standard care for sepsis

Treatment:

Other: Best standard care