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Mycobacterium w in Patients With Severe Sepsis (MISS)

Primary Purpose

Sepsis

Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
Mycobacterium w
Best standard care
Sponsored by
Postgraduate Institute of Medical Education and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Pulmonary Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mycobacterium w group

Best standard care

Arm 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

Best standard care for sepsis

Outcomes

Primary Outcome Measures

Mortality
28-day all-cause mortality

Secondary Outcome Measures

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

Full Information

First Posted
December 26, 2014
Last Updated
February 22, 2021
Sponsor
Postgraduate Institute of Medical Education and Research
Collaborators
Pandit Bhagwat Dayal Sharma, PGIMS, Rohtak, St.John's National Academy of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02330432
Brief Title
Mycobacterium w in Patients With Severe Sepsis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
October 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Postgraduate Institute of Medical Education and Research
Collaborators
Pandit Bhagwat Dayal Sharma, PGIMS, Rohtak, St.John's National Academy of Health Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mycobacterium w group
Arm Type
Experimental
Arm 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
Arm Title
Best standard care
Arm Type
Active Comparator
Arm Description
Best standard care for sepsis
Intervention Type
Biological
Intervention Name(s)
Mycobacterium w
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Best standard care
Intervention Description
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 Outcome Measure Information:
Title
Mortality
Description
28-day all-cause mortality
Time Frame
28-day
Secondary Outcome Measure Information:
Title
New onset organ dysfunction measured by delta SOFA (maximum minus baseline SOFA)
Description
Measured by delta SOFA (maximum minus baseline SOFA)
Time Frame
28-day
Title
Ventilator-free days
Description
Day off the mechanical ventilator
Time Frame
28-day
Title
Time-to-vasopressor withdrawal
Time Frame
28-day
Title
ICU length of stay
Time Frame
28-day
Title
Hospital length of stay
Time Frame
28-day
Title
New-onset infection
Time Frame
28-day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Department of Pulmonary Medicine
City
Chandigarh
State/Province
UT
ZIP/Postal Code
160012
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
25241089
Citation
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.
Results Reference
result
PubMed Identifier
33852919
Citation
Sehgal IS, Basumatary NM, Dhooria S, Prasad KT, Muthu V, Aggarwal AN, Pal A, Desai M, Chaudhry D, Supe PD, Kurmi P, Choudhuri R, Shah C, Agarwal R. A Randomized Trial of Mycobacterium w in Severe Presumed Gram-Negative Sepsis. Chest. 2021 Oct;160(4):1282-1291. doi: 10.1016/j.chest.2021.03.062. Epub 2021 May 7.
Results Reference
derived

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Mycobacterium w in Patients With Severe Sepsis

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