Mycobacterium w in Patients With Severe Sepsis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-10-31

Brief Summary

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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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Detailed Description

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Conditions

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Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Mycobacterium w group

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

Group Type EXPERIMENTAL

Mycobacterium w

Intervention Type 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

Intervention Type 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

Best standard care

Best standard care for sepsis

Group Type ACTIVE_COMPARATOR

Best standard care

Intervention Type 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

Interventions

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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

Intervention Type BIOLOGICAL

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No