Study of Inj. Sepsivac® in bacterial sepsis

Study of Inj. Sepsivac® in gram negative sepsis - NA

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/01/061600

Enrollment

Registered

2024-01-18

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: A415- Sepsis due to other Gram-negativeorganisms

Interventions

Intervention1: 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.

Eligibility

Inclusion criteria

Inclusion criteria: Presumed or Suspected or Confirmed Sepsis due to gram negative infection

Exclusion criteria

Exclusion criteria: • History of allergic reactions attributed to Inj. Sepsivac® or any of its excipients • Pregnant and lactating women

Design outcomes

Primary

Measure	Time frame
28 days all-cause mortalityTimepoint: Day 1, 2, 3, 4, 7, 14, 28	—

Secondary

Measure	Time frame
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 stayTimepoint: Baseline, Day 1, 2, 3, 4, 7, 14, 28	—

Countries

India

Contacts

Public ContactDr Preeti Navik

Cadila Pharmaceuticals Ltd

preeti.navik@cadilapharma.com9727887305

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026