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CTRI Number  CTRI/2023/03/051018 [Registered on: 23/03/2023] Trial Registered Prospectively
Last Modified On: 20/03/2023
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   A Post Marketing Surveillance of inj. mycobacterium w in patients with Gram Negative Sepsis  
Scientific Title of Study   Post Marketing Surveillance of inj. Sepsivac® (Mycobacterium w) to evaluate safety and efficacy in combination with standard therapy in gram negative bacterial sepsis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CPL072020/1, Version No.3 dated 27/08/21  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Manav Manchanda 
Designation  Director & Head- Respiratory, Critical Care & Sleep Medicine  
Affiliation  Asian Institute of Medical Sciences 
Address  Respiratory OPD block, 2nd floor, Asian Institute of Medical Sciences Badkal Flyover Road, Sector - 21 A Faridabad - 121001 Haryana, India

Faridabad
HARYANA
121001
India 
Phone  9650099137  
Fax    
Email  manav.manchanda@aimsindia.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pratik Patel 
Designation  Assistant General Manager 
Affiliation  Cadila Pharmaceuticals LTd 
Address  Cadila Pharmaceuticals LTd., Cadila Corporate Campus, Sarkhej - Dholka Road, Bhat, Ahmedabad - 382210
Cadila Pharmaceuticals LTd., Cadila Corporate Campus, Sarkhej - Dholka Road, Bhat, Ahmedabad - 382210
Ahmadabad
GUJARAT
382210
India 
Phone  09825468678  
Fax    
Email  pratik.patel@cadilapharma.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Pratik Patel 
Designation  Assistant General Manager 
Affiliation  Cadila Pharmaceuticals LTd 
Address  Cadila Pharmaceuticals LTd., Cadila Corporate Campus, Sarkhej - Dholka Road, Bhat, Ahmedabad - 382210
Cadila Pharmaceuticals LTd., Cadila Corporate Campus, Sarkhej - Dholka Road, Bhat, Ahmedabad - 382210
Ahmadabad
GUJARAT
382210
India 
Phone  09825468678  
Fax    
Email  pratik.patel@cadilapharma.co.in  
 
Source of Monetary or Material Support  
Cadila Pharmaceuticals LTd., Cadila Corporate Campus, Sarkhej - Dholka Road, Bhat, Ahmedabad - 382210 Ahmadabad GUJARAT 382210 India  
 
Primary Sponsor  
Name  Cadila Pharmaceuticals Ltd. 
Address  Cadila Pharmaceuticals Ltd., Cadila Corporate campus, Bhat, Sarkhej-Dholka road, Ahmedabad -382210 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajat Agarawal  Fortis escorts heart institute  2nd floor, OPD block, Fortis escorts heart institute, okhala road, New Delhi
New Delhi
DELHI 		 9818851504

Rajat.agarawal@fortishealthcare.com 
Dr Tariq Mahmood  Moti Lal Nehru Medical College  L-6, Department of pulmonary medicine, Moti Lal Nehru Medical College campus, Allahabad, George Town, Allahabad, Uttar Pradesh 211002
Allahabad
UTTAR PRADESH 		 9415261197

mlnmctariqmahmood@gmail.com 
Dr Puneet Singh  Perhar metarnity and general hospital  Ground floor, 403-L, Perhar metarnity and general hospital, Model town, Jalandhar
Jalandhar
PUNJAB 		 9779149838

puneetperhar@yahoo.com 
Dr Piyush Patil  Prime care hospital   Ground flood, Prime care hospital, Ekveera chawk, Pipelineroad, savedi, Ahmednagar, Maharashtra
Ahmadnagar
MAHARASHTRA 		 7798688005

drpiyush.patil@gmail.com 
Dr Saurabh Singhal  Swami Vivekanand Subharti Medical college  Subhartipuram, NH- 58, Delhi-Haridwar,Meerut Bypass Rd, Meerut, Uttar Pradash-250005
Meerut
UTTAR PRADESH 		 9412578157

Singhaldnb2007@yahoo.co.in 
Dr Sudershana Gunwant Patil  WOCHARDT HOSPITAL  1sr floor, OPD block, WOCHARDT HOSP. WANI HOUSE MUMBAI AGRA ROAD NASIK 422001
Mumbai
MAHARASHTRA 		 9822857873

dershana01@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
ACEAS-IEC  Approved 
ACEAS-IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A415||Sepsis due to other Gram-negativeorganisms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Injection Sepsivac® (Mycobacterium W)  Dose- 0.3 ml Route of administration- intra-dermally per day at three different sites Duration- 3 consecutive days 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Sepsis patients with gram negative infection having age between 18 to 65 years (Both inclusive) where, Sepsis is defined as suspected or documented infection and an acute increase of ⩾2 SOFA points.5 AND having at least one of the following:
Source of Gram negative sepsis presumed to be originating from these sources (gastrointestinal, hepatobiliary, genitourinary tract, pulmonary, neurological) or
Documented by typical clinical signs and symptoms and confirmed by blood culture and/or histology or
Documented by typical clinical signs and symptoms and confirmed by CSF culture/tissue culture and/or histology or
Positive culture or histology confirmation or any other investigation deemed necessary must be obtained at the time of enrolment and prior to the first dose of study medication. 
 
ExclusionCriteria 
Details  History of allergic reactions attributed to Mycobacterium w (Heat Killed) injection or any of the excipients in the formulation.
Pregnant and Lactating women.
Individuals with generalized septic skin conditions (if eczema exists, a site should be chosen that is free from skin lesions).
Patient with chronic debilitating condition other than the proposed indication. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Safety assessment of Inj. Sepsivac® in the patients of sepsis  1,2,3,4,7,14,28 days  
 
Secondary Outcome  
Outcome  TimePoints 
Efficacy assessment of Inj. Sepsivac® in the patients of sepsis  28 days 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   15/04/2023 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Sepsis is a life-threatening organ dysfunction caused by a dysregulated response of the host to an infection. This definition is fully recognizing two crucial elements in pathogenesis: the infection and the dysregulated host response. Sepsis remains an important and life-threatening problem and the most common cause of death in the ICU with mortality between 20 to 50% for sepsis and 45 to 80% for septic shock.  Mycobacterium w (Mw) is a nonpathogenic, rapidly growing atypical mycobacterium classifiable in Runyon group IV. It shares T and B cell determinants with Mycobacterium leprae and Mycobacterium tuberculosis. When heat-inactivated and administered intradermally, it works as a poly TLR antagonist (TLR – 4, 5, 7, 9), MAPK modulator, cytokine suppressor, inhibitor of cytokine - induced NO release and it reverses LPS induced events. In a gene expression profile, it was observed that the genes that are modulated in sepsis get REVERSE modulated by Mw stimulation, indicating that Mw may/shall work in treatment of sepsis. Mw has been subjected to extensive toxicological studies as per the guidelines of Indian Council of Medical Research (ICMR) in 2 species of animals and has been adjudged safe and devoid of toxicity. In other experiments, administration of large doses of live Mw, by various routes did not cause any mortality in mice and guinea pigs, confirming the non-pathogenic nature of the bacillus. Aims of the study is to evaluate the safety and efficacy of Sepsivac® (Mycobacterium W) along with standard of care treatment in patients with sepsis. Study will be conducted on minimum 200 patients diagnosed to have sepsis due to gram negative bacteria with acute increase of ⩾2 SOFA points. After obtaining informed consent, each patient will receive Inj. Sepsivac®.  The patients will be administered the study medication Inj. Sepsivac® (Mycobacterium w) intradermally along with standard of care therapy. 0.3 ml/day of Inj. Sepsivac® will be administered as intra-dermal injections for three consecutive days as 0.1ml x 3 injections at different sites. Primary objective is to assess the safety of Inj. Sepsivac® in the patients of sepsis and Secondary objectives is to assess the efficacy of Inj. Sepsivac® in the patients of sepsis. 
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