| CTRI Number |
CTRI/2025/11/097660 [Registered on: 18/11/2025] Trial Registered Prospectively |
| Last Modified On: |
05/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Strengthening the Immune System in Septic Shock: The Role of Mycobacterium w |
|
Scientific Title of Study
|
Mycobacterium w in Septic Shock by Gram Negative infections in intensive care unit: A randomized controlled pilot study (MySSGraNe Trial) |
| Trial Acronym |
MySSGraNe Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
| NIL |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jay Prakash |
| Designation |
Associate Professor |
| Affiliation |
Rajendra Institute of Medical Sciences |
| Address |
Department of Critical Care Medicine, Rajendra Institute of Medical Sciences, Bariatu, Ranchi
Department of Critical Care Medicine, Rajendra Institute of Medical Sciences, Bariatu, Ranchi
Ranchi
JHARKHAND
834009
India |
| Phone |
8084715507 |
| Fax |
|
| Email |
dr.jay_prakash@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jay Prakash |
| Designation |
Associate Professor |
| Affiliation |
Rajendra Institute of Medical Sciences |
| Address |
Department of Critical Care Medicine, Rajendra Institute of Medical Sciences, Bariatu, Ranchi
Department of Critical Care Medicine, Rajendra Institute of Medical Sciences, Bariatu, Ranchi
Ranchi
JHARKHAND
834009
India |
| Phone |
8084715507 |
| Fax |
|
| Email |
dr.jay_prakash@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jay Prakash |
| Designation |
Associate Professor |
| Affiliation |
Rajendra Institute of Medical Sciences |
| Address |
Department of Critical Care Medicine, Rajendra Institute of Medical Sciences, Bariatu, Ranchi
Department of Critical Care Medicine, Rajendra Institute of Medical Sciences, Bariatu, Ranchi
Ranchi
JHARKHAND
834009
India |
| Phone |
8084715507 |
| Fax |
|
| Email |
dr.jay_prakash@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Rajendra Institute of Medical Sciences, Ranchi |
|
|
Primary Sponsor
|
| Name |
Rajendra Institute of Medical Sciences, Ranchi |
| Address |
Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Jharkhand, India
PIN-834009
|
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| Not secondary Sponsor |
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jay Prakash |
Rajendra Institute of Medical Sciences, Ranchi |
Department of Critical Care Medicine, Rajendra Institute of Medical Sciences, Baratu, Ranchi
Ranchi
JHARKHAND |
8084715507
dr.jay_prakash@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethic Committee, Rajendra Institute of Medical Sciences (RIMS), RANCHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: A499||Bacterial infection, unspecified, (2) ICD-10 Condition: A488||Other specified bacterial diseases, (3) ICD-10 Condition: Y999||Unspecified external cause status, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Matching Placebo in similar vial |
The active drug and matching placebo will be provided in similar vials and labelled according to the randomization sequence. The study drug will be injected by a person not directly involved in patient care and data analysis. The investigators and the patients at each participating centre will be blinded. |
| Intervention |
Mycobacterium w (Heat Killed)
|
As an immunomodulator, the mycobacterium w (Mw) has improved outcomes for patients suffering from severe sepsis. It’s innovation in Sepsis management and the drug has received approval from Drug Controller General of India (DCGI) for immunotherapy treatment in Sepsis or septic shock. Sepsivac contains mycobacterium w, an immunomodulator which is a non-pathogenic mycobacterium. As a result of the immunomodulator effect, Sepsivac effectively saves more lives in sepsis. Randomized trials in sepsis patients showed 11% absolute reduction and 55.5% relative reduction in mortality. Sepsivac reduces the days on ventilator, ICU stay, hospital stay, incidences of secondary infection and days on vasopressor & reduces the SOFA score. |
| Intervention |
Sepsivac |
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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with septic shock
systolic blood pressure less than or equal to 90 mm Hg or the mean arterial pressure less than or equal to 65 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 more than 90 and more than 65 mm Hg, respectively
|
|
| ExclusionCriteria |
| Details |
Pregnancy or lactating mother
Gram-positive culture
Only fungal infection as a source of sepsis
Patients who received cardiopulmonary resuscitation
Those on immunosuppressive therapy
Those unwilling to provide informed consent
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome: Vasopressor free days
|
28-days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary outcome [Time Frame: 28-day]:
Duration of antibiotic use
New onset organ dysfunction- measured by delta SOFA (maximum minus baseline SOFA)
Ventilator-free days
Day off the mechanical ventilator
Time-to-vasopressor withdrawal (number of days receiving vasopressor drugs)
ICU length of stay
Hospital length of stay
New-onset infection (rate of secondary nosocomial infections)
|
28-days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
12/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This randomized, double-blind pilot study aims to evaluate the immunomodulatory effect of Mycobacterium w (Mw, Mycobacterium indicus pranii) on vasopressor requirements in patients with septic shock due to Gram-negative infections. Sepsis remains a leading cause of ICU mortality worldwide, with immune dysregulation complicating its management. Conventional therapies targeting single inflammatory pathways have failed, whereas immunomodulators such as Mw, shown previously to enhance Th1 responses and reduce ICU stays, may offer therapeutic benefit.
The study will recruit 50 adult patients with septic shock meeting inclusion criteria, randomized equally to receive either Mw (0.3 mL intradermally for three consecutive days) plus standard care, or placebo plus standard care. The primary endpoint is vasopressor-free days at 28 days. Secondary outcomes include ventilator-free days, antibiotic duration, time-to-vasopressor withdrawal, ICU/hospital length of stay, and incidence of nosocomial infections.
Patients will undergo daily clinical and hemodynamic monitoring, SOFA scoring, and laboratory assessments (CBC, ABG, LFT, RFT, CRP, PCT, D-dimer) until day 14 and on day 28. Randomization will be computer-generated, with investigators and patients blinded. Statistical analyses will follow an intention-to-treat approach.
This pilot trial will provide preliminary evidence on the safety and efficacy of Mw as an adjunctive therapy for septic shock, potentially paving the way for larger multicenter studies. |