NCT02330432

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P50-P75 for phase_2 sepsis

Timeline
Completed

Started Jan 2016

Typical duration for phase_2 sepsis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 5, 2015

Completed
12 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2018

Completed
Last Updated

February 23, 2021

Status Verified

February 1, 2021

Enrollment Period

2.8 years

First QC Date

December 26, 2014

Last Update Submit

February 22, 2021

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

  • Mortality

    28-day all-cause mortality

    28-day

Secondary Outcomes (6)

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

    28-day

  • Ventilator-free days

    28-day

  • Time-to-vasopressor withdrawal

    28-day

  • ICU length of stay

    28-day

  • Hospital length of stay

    28-day

  • +1 more secondary outcomes

Study Arms (2)

Mycobacterium w group

EXPERIMENTAL

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

Biological: Mycobacterium wOther: Best standard care

Best standard care

ACTIVE COMPARATOR

Best standard care for sepsis

Other: Best standard care

Interventions

Mycobacterium wBIOLOGICAL

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

Mycobacterium w group
Best standard careOTHER

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

Best standard careMycobacterium w group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pulmonary Medicine

Chandigarh, Uttarakhand, 160012, India

Location

Related Publications (2)

  • 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.

    PMID: 25241089RESULT

  • 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.

    PMID: 33852919DERIVED

MeSH Terms

Conditions

Sepsis

Interventions

Mycobacterium w vaccine

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Additional Professor

Study Record Dates

First Submitted

December 26, 2014

First Posted

January 5, 2015

Study Start

January 1, 2016

Primary Completion

October 31, 2018

Study Completion

October 31, 2018

Last Updated

February 23, 2021

Record last verified: 2021-02

Locations

IN(1)