| CTRI Number |
CTRI/2024/01/061600 [Registered on: 18/01/2024] Trial Registered Prospectively |
| Last Modified On: |
10/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of Inj. Sepsivac® in bacterial sepsis |
|
Scientific Title of Study
|
Study of Inj. Sepsivac® in gram negative sepsis |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Madhusudhan Jaju |
| Designation |
Head, Critical Care Medicine |
| Affiliation |
Yashoda Hospital |
| Address |
6th floor, critical care department, Yashoda hospital Behind Hari Hara Kala Bhavan,SP Road, Secunderabad - 500003, Telangana, India
Hyderabad
TELANGANA
500003
India |
| Phone |
9440379476 |
| Fax |
|
| Email |
madhu_jaju123@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preeti Navik |
| Designation |
Manager-Medical Affairs |
| Affiliation |
Cadila Pharmaceuticals Ltd |
| Address |
Ground floor, Medical team, Cadila Pharmaceuticals,
Sarkhej-Dholka Road, Bhat, Ahmedabad, India, 382210
Ahmadabad
GUJARAT
382210
India |
| Phone |
9727887305 |
| Fax |
|
| Email |
preeti.navik@cadilapharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Preeti Navik |
| Designation |
Manager-Medical Affairs |
| Affiliation |
Cadila Pharmaceuticals Ltd |
| Address |
Ground floor, Medical team, Cadila Pharmaceuticals,
Sarkhej-Dholka Road, Bhat, Ahmedabad, India, 382210
Ahmadabad
GUJARAT
382210
India |
| Phone |
9727887305 |
| Fax |
|
| Email |
preeti.navik@cadilapharma.com |
|
|
Source of Monetary or Material Support
|
| Cadila Pharmaceuticals LTD, Cadila Corporate Campus, Sarkhej- Dholka Road, Bhat, Ahmedabad- 382210, Ahmedabad Gujarat |
|
|
Primary Sponsor
|
| Name |
Cadila Pharmaceuticals LTD |
| Address |
Cadila Corporate Campus, Sarkhej- Dholka Road, Bhat, Ahmedabad- 382210, Ahmedabad Gujarat |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of 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 Madhusudan Jaju |
Yashoda Hospital |
6th floor, critical care department, Yashoda hospital Behind Hari Hara Kala Bhavan,SP Road, Secunderabad - 500003, Telangana, India
Hyderabad
TELANGANA |
9440379476
madhu_jaju123@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-YAMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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) |
Inj. Sepsivac® 0.6 ml diluted in 10-100 ml NS to be given as slow IV infusion over at least 15 minutes, every day for minimum 3 consecutive days. |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Presumed or Suspected or Confirmed Sepsis due to gram negative infection |
|
| ExclusionCriteria |
| Details |
• History of allergic reactions attributed to Inj. Sepsivac® or any of its excipients
• Pregnant and lactating women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 28 days all-cause mortality |
Day 1, 2, 3, 4, 7, 14, 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in clinical and laboratory parameters
2. Change in SOFA score
3. Effect on vasopressor dosage
4. Allergic reaction post Inj Sepsivac
5. Days on ventilator and vasopressor
6. Intensive Care Unit length of stay |
Baseline, Day 1, 2, 3, 4, 7, 14, 28 |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
24/01/2024 |
| 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="0"
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
|
Based on the efficacy
and safety data of Mycobacterium w (Mw) as observed in previous clinical
studies, we hypothesize that using Mw as adjuvant to standard treatment in
sepsis via intravenous route will be safe as well as effective in decreasing
complications, hasten the organ function recovery and reduce the 28 day
mortality associated with sepsis. |