Health Condition 1: A415- Sepsis due to other Gram-negativeorganisms
Conditions
Interventions
Intervention1: Injection Sepsivac® (Mycobacterium W): Dose- 0.3 ml
Route of administration- intra-dermally per day at three different sites
Duration- 3 consecutive days
Control Intervention1: NA: N
Sponsors
Cadila Pharmaceuticals Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety assessment of Inj. Sepsivac® in the patients of sepsisTimepoint: 1,2,3,4,7,14,28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy assessment of Inj. Sepsivac® in the patients of sepsisTimepoint: 28 days | — |
Countries
India
Contacts
Public ContactDr Pratik Patel
Cadila Pharmaceuticals LTd
Outcome results
None listed