A Post Marketing Surveillance of inj. mycobacterium w in patients with Gram Negative Sepsis
- Conditions
- Health Condition 1: A415- Sepsis due to other Gram-negativeorganisms
- Registration Number
- CTRI/2023/03/051018
- Lead Sponsor
- Cadila Pharmaceuticals Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety assessment of Inj. Sepsivac® in the patients of sepsisTimepoint: 1,2,3,4,7,14,28 days
- Secondary Outcome Measures
Name Time Method Efficacy assessment of Inj. Sepsivac® in the patients of sepsisTimepoint: 28 days