Phase IIb Randomized, Double Blind, Two Arm, Controlled Clinical Trial of Mycobacterium W in Combination With Standard Therapy Versus Standard Therapy Alone in Sepsis

Post Graduate Institute of Medical Education and Research, Chandigarh1 site in 1 country202 target enrollmentJanuary 2016

ConditionsSepsis

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Sepsis
Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh
Enrollment: 202
Locations: 1
Primary Endpoint: Mortality
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2016

End Date

October 31, 2018

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Responsible Party

Principal Investigator

Ritesh Agarwal

Additional Professor

Post Graduate Institute of Medical Education and Research, Chandigarh

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

Outcomes

Primary Outcomes

Mortality

Time Frame: 28-day

28-day all-cause mortality

Secondary Outcomes

New onset organ dysfunction measured by delta SOFA (maximum minus baseline SOFA)(28-day)
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)