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OpenTrials
Completed

NCT Number: NCT02330432

Mycobacterium w in Patients With Severe Sepsis

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of Pulmonary Medicine

Chandigarh, Uttarakhand, 160012, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mycobacterium w

Biological

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

Best standard care

Other

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

Primary outcomes

  1. Mortality

    Time frame: 28-day

    28-day all-cause mortality

Secondary outcomes

  1. New onset organ dysfunction measured by delta SOFA (maximum minus baseline SOFA)

    Time frame: 28-day

    Measured by delta SOFA (maximum minus baseline SOFA)

  2. Ventilator-free days

    Time frame: 28-day

    Day off the mechanical ventilator

  3. Time-to-vasopressor withdrawal

    Time frame: 28-day

  4. ICU length of stay

    Time frame: 28-day

  5. Hospital length of stay

    Time frame: 28-day

  6. New-onset infection

    Time frame: 28-day

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Collaborators

  • Pandit Bhagwat Dayal Sharma, PGIMS, Rohtak
  • St.John's National Academy of Health Sciences

Registry information

Official study 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

Acronym: MISS

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 5, 2015
Registry last updated
Feb 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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