| CTRI Number |
CTRI/2008/091/000292 [Registered on: 17/04/2009] |
| Last Modified On: |
21/02/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug
Vaccine |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
A clinical trial to optimize the dose level and evaluate the safety and efficacy potential of drug Mycobacterium w. in Sepsis |
Scientific Title of Study
Modification(s)
|
Randomized, Double bind, Two arm, Multicentric, Comparative Controlled ,Prospective Clinical trial of Mycobacterium w in combination with satandard therapy versus standard therapy alone in sepsis due to gram(-)ve infections. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| 70/1192 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Sanjay Jain |
| Designation |
|
| Affiliation |
|
| Address |
Prof of Internal Medicine
PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
911722756677 |
| Fax |
911722744401 |
| Email |
sanjayvanita@yahoo.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Sanjay Jain |
| Designation |
|
| Affiliation |
|
| Address |
Prof of Internal Medicine
PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
911722756677 |
| Fax |
911722744401 |
| Email |
sanjayvanita@yahoo.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Sanjay Jain |
| Designation |
|
| Affiliation |
|
| Address |
Prof of Internal Medicine
PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
911722756677 |
| Fax |
911722744401 |
| Email |
sanjayvanita@yahoo.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Cadila Pharmaceutical Limited |
|
Primary Sponsor
Modification(s)
|
| Name |
CSIR Govt of India |
| Address |
Council of Scientific and Industrial Research (CSIR)
Anusandhan Bhawan, 2, Rafi Marg, New Delhi - 110 001
&
|
| Type of Sponsor |
Government funding agency |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| Cadila Pharmaceuticals Limited |
1389, Trasad Road,
Dholka,
Ahmedabad
India |
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanjai jain |
PGIMER |
Prof. of internal Medicine,PGIMER-
Chandigarh
CHANDIGARH |
911722756677
911722744401
sanjaivanita@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institue Ethics Committee, PGIMER Chandigarh |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A415||Sepsis due to other Gram-negativeorganisms, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
mycobacterium W |
Group 1:0.1 ml/day consecutive days intra-dermal.
Group2:- 0.2 ml/per day(0.1X2) for 3 consucutive days intradermal
Group 3:0.3ml/day(0.1X3)for 3 consucutive days intradermal
Group |
| Comparator Agent |
sTANDARD THERAPY FOR SEPSIS |
The therapy of each patient will be individualized based on his/her specific clinical characteristics. The therapy will consist of:
1.Oxygen :
a. All patients will receive oxygen to keep SaO2 90% or Pao2 60mm Hg.
b. Intubation and or mechanical ventilation will be done as and when required.
2. Perfusion:
a. Central line catheter will be put in all patients.
b. Fluids will be administered to keep CVP 8-12mm Hg.
c. Vasopressors will be used to keep Systolic pressure above 90mm Hg. Vasopressors used will be Dopamine and/or Norepinephrine
d. Packed cell transfusion as per discretion of the treating doctor
3. Source control of infection:
a. Surgical intervention/Drainage of pus, if any and deemed necessary by treating doctor
4. Antibiotics
Either alone or combination
a. Cephalosporins: Third generation or fourth generation
b. Imipenam or Meropenam
c. Aminoglycosides
Doses and duration of antibiotic therapy will be as per decisions of the treating doctor. Minimum 7 days of antibiotic therapy will be administered. These drugs may be modified once microbiological sensitivity is found to be different.
5. Nutrition support
Enteral nutrition will be provided as per discretion of physicians
|
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adults of either gender with both margins inclusive(18-65 years) with a diagnosis of Severe systemic gram negative sepsis or septic shock.
|
|
| ExclusionCriteria |
| Details |
Patients with history of allergy,hypersensitivity, or any serious reaction to Mycobacterium w. and with a concomitant medical condition,which may create an unacceptable additional risks |
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
Modification(s)
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| To determine the mortality at different dose levels in comparision to standard therapy. |
28 days |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Effects on organ function |
28 days |
| Assess safety/tolerability by detyerminig the incidence of adverse events in the treatments group versus control |
28 days |
| Effects on serum IL-6,IL-8, TNF-alpha,C3B and CRP levels |
28 days |
|
Target Sample Size
Modification(s)
|
Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
10/03/2009 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is a randomized double blind, two arms, multicentric, comparative controlled prospective clinical trial of mycobacterium w in combination with standard therapy versus standard therapy alone in sepsis due to gram (-) infections for six month (28 days in each groups) in 72 patients (devide into three groups) that will be conducted in three centers. The primary outcome to determine the 28 days mortality at different dose levels in comparisions to standard therapy. The secondary outcome to observe effacts on organ function and to assess safety and tolerability by determinig the incidence of adverse events in the treatment groups versus control and to observe the effects on serum IL-6,IL-8,TNF-alpha,C3B and CRP levls. |