Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-01-07 @ 5:43 PM
Study NCT ID:
NCT02025660
Status:
COMPLETED
Last Update Posted:
2014-03-20
First Post:
2013-12-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Mw Vaccine in Treatment of Severe Sepsis
Sponsor:
Post Graduate Institute of Medical Education and Research, Chandigarh
Organization:
Study Overview
Official Title:
Does Immune-modulation Improve the Survival in Patients With Severe Sepsis? "A Proof of the Concept Study"
Status:
COMPLETED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MISS
Brief Summary:
Study Hypothesis Enhancement of Th-1 response with the help of a poly TLR agonist (Mw) is likely to increase survival in patients with severe sepsis.
Objectives To study whether immunomodulation with Mycobacterium Mw helps in improving survival and the recovery of organ function in patients with severe sepsis. This will be assessed with the help of the following
* Mortality in the two arms
* Daily SOFA scores
* Ventilator free days
* Time-to-vasopressor withdrawal
* ICU length of stay
* Hospital length of stay METHODS This will be a proof of the concept study to assess the effect of Mycobacterium w in combination with standard therapy versus standard therapy alone on the inflammatory profile in sepsis due to gram negative infection. A total of 25 patients will be enrolled in each group. The patients will be randomized in balance to receive either test drug or its placebo along with the standard of care
Objectives To study whether immunomodulation with Mycobacterium Mw helps in improving survival and the recovery of organ function in patients with severe sepsis. This will be assessed with the help of the following
* Mortality in the two arms
* Daily SOFA scores
* Ventilator free days
* Time-to-vasopressor withdrawal
* ICU length of stay
* Hospital length of stay METHODS This will be a proof of the concept study to assess the effect of Mycobacterium w in combination with standard therapy versus standard therapy alone on the inflammatory profile in sepsis due to gram negative infection. A total of 25 patients will be enrolled in each group. The patients will be randomized in balance to receive either test drug or its placebo along with the standard of care
Detailed Description:
This will be a proof of the concept study to assess the effect of Mycobacterium w in combination with standard therapy versus standard therapy alone on the inflammatory profile in sepsis due to gram negative infection. The study will be conducted in the respiratory intensive care unit at PGIMER, Chandigarh, over a period of 1 year. A total of 25 patients will be enrolled in each group. The patients will be randomized in balance to receive either test drug or its placebo along with the standard of care
In addition to the standard therapy for sepsis, patients randomized to test arm will receive single daily dose of 0.3 ml of Mw intra-dermal for 3 consecutive days while patients randomized to control arm will receive single daily dose of 0.3 ml of Mw-placebo intra-dermal for 3 consecutive days.
Study Duration Study duration for each patient will be 28 days. Follow up period is included in the study duration of 28 days
Study Outlines and Timing of Visits Eligible patients will be enrolled after due consent and randomized to one of the treatment arms. The enrolled patients will be monitored for any adverse events (AEs) or serious adverse events (SAEs) throughout the study period. All patients will continue to receive standard therapy till considered requisite
In addition to the standard therapy for sepsis, patients randomized to test arm will receive single daily dose of 0.3 ml of Mw intra-dermal for 3 consecutive days while patients randomized to control arm will receive single daily dose of 0.3 ml of Mw-placebo intra-dermal for 3 consecutive days.
Study Duration Study duration for each patient will be 28 days. Follow up period is included in the study duration of 28 days
Study Outlines and Timing of Visits Eligible patients will be enrolled after due consent and randomized to one of the treatment arms. The enrolled patients will be monitored for any adverse events (AEs) or serious adverse events (SAEs) throughout the study period. All patients will continue to receive standard therapy till considered requisite
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: