Study of Inj. Sepsivac® in bacterial sepsis
Phase 4
- Conditions
- Health Condition 1: A415- Sepsis due to other Gram-negativeorganisms
- Registration Number
- CTRI/2024/01/061600
- 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
Inclusion Criteria
Presumed or Suspected or Confirmed Sepsis due to gram negative infection
Exclusion Criteria
•History of allergic reactions attributed to Inj. Sepsivac® or any of its excipients
•Pregnant and lactating women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 28 days all-cause mortalityTimepoint: Day 1, 2, 3, 4, 7, 14, 28
- Secondary Outcome Measures
Name Time Method 1.Change in clinical and laboratory parameters <br/ ><br>2.Change in SOFA score <br/ ><br>3.Effect on vasopressor dosage <br/ ><br>4.Allergic reaction post Inj Sepsivac <br/ ><br>5.Days on ventilator and vasopressor <br/ ><br>6.Intensive Care Unit length of stayTimepoint: Baseline, Day 1, 2, 3, 4, 7, 14, 28