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Study to investigate the effectiveness and safety of Inj.Sepsivac in gram negative sepsis patients

Study of Inj. Sepsivac® in gram negative sepsis

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/02/030882
Enrollment
20
Registered
2021-02-01
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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: Intravenous Mycobaterium (Mw) and Standard of care treatment: Inj. Sepsivac® 0.3 ml diluted in 10-100 ml NS to be given as slow IV infusion over at least 15 minutes, every day for 3 con

Sponsors

Medanta The Medicity
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients presumed to have gram-negative sepsis(Clinically Diagnosed) 2.Age between 18 to 65 years (both inclusive) 3.Agrees to Provide Consent

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 4. Not willing to provide Consent 5. Patient not clinically diagnosed with Gram-ve sepsis

Design outcomes

Primary

MeasureTime frame
All Cause MortalityTimepoint: 28 days

Secondary

MeasureTime frame
Days on ventilator and vasopressor, Intensive Care Unit length of stay, Change in SOFA score, To monitor adverse eventsTimepoint: 3, 7, 14, 28 days

Countries

India

Contacts

Public ContactDr Yatin Mehta

Institute of Critical Care and Anesthesia

yatin.mehta@medanta.org0124-4141414

Outcome results

None listed

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