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Mycobacterium w in Patients With Severe Sepsis

NCT02330432 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2021-02-23

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

Mycobacterium w

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

OTHER

Best standard care

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

Sponsors & Collaborators

  • Post Graduate Institute of Medical Education and Research, Chandigarh

    lead OTHER

  • Pandit Bhagwat Dayal Sharma, PGIMS, Rohtak

    collaborator OTHER

  • St.John's National Academy of Health Sciences

    collaborator OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2018-10-31
Completion
2018-10-31

Countries

  • India

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02330432 on ClinicalTrials.gov