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Sepsivac in gram negative sepsis

Study of intravenous Inj Sepsivac (heat killed mycobacterium w) in gram negative sepsis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/08/035408
Enrollment
30
Registered
2021-08-04
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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: Inj. Sepsivac 0.6 ml: Heat killed Mycobacterium w given IV as adjuvant to SOC everyday for three consecutive day Control Intervention1: Inj. Sepsivac 0.3 ml: Heat killed Mycobacterium w

Sponsors

CARE Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient matching >= 2 criteria of qSOFA 2. Patients with level of procalcitonin >= 2 ng/ml 3. Age between 18 to 65 years (both inclusive)

Exclusion criteria

Exclusion criteria: 1. History of allergic reactions attributed to Inj. Sepsivac® or any of its excipients 2. Pregnant and lactating women 3. Generalized septic skin conditions

Design outcomes

Primary

MeasureTime frame
All-cause mortalityTimepoint: 28 days—

Secondary

MeasureTime frame
1. Days on ventilator and vasopressor 2. Intensive Care Unit length of stay 3. Change in SOFA score 4. To monitor adverse events Timepoint: Day 1, 2, 3, 4, 7, 14, 28—

Countries

India

Contacts

Public ContactDr Shweta Chandankhede

CARE Hospital

shwets0106@gmail.com9963431945

Outcome results

None listed

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