Mycobacterium w in Patients With Severe Sepsis

Phase 2

Completed

• Conditions: Sepsis
• Interventions: Biological: Mycobacterium w; Other: Best standard care

• Registration Number: NCT02330432
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-26
• Study First Submitted QC: 2014-12-31
• Study First Posted: 2015-01-05
• Study Start: 2016-01
• Primary Completion: 2018-10-31
• Study Completion: 2018-10-31
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-22
• Last Update Posted: 2021-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mycobacterium w group	Best standard care	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	Best standard care	Best standard care for sepsis
Mycobacterium w group	Mycobacterium w	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

Primary Outcome Measures

Name	Time	Method
Mortality	28-day	28-day all-cause mortality

Secondary Outcome Measures

Name	Time	Method
New onset organ dysfunction measured by delta SOFA (maximum minus baseline SOFA)	28-day	Measured by delta SOFA (maximum minus baseline SOFA)
Hospital length of stay	28-day
New-onset infection	28-day
ICU length of stay	28-day
Time-to-vasopressor withdrawal	28-day
Ventilator-free days	28-day	Day off the mechanical ventilator

Trial Locations

Locations (1)

Department of Pulmonary Medicine; 🇮🇳 Chandigarh, UT, India