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To evaluate safety and efficacy of Inj. Sepsivac® IV in gram negative sepsis

Study of Inj. Sepsivac® in gram negative sepsis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/01/030585
Enrollment
20
Registered
2021-01-19
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Health Condition 1: B999- Unspecified infectious disease

Interventions

Intervention1: Inj. Sepsivac®: All the patients will receive single daily dose of 0.6 ml of Inj. Sepsivac® IV for 3 consecutive days. The study drug will be administered within 48 hours of onset of fi

Sponsors

Dr Subba Reddy K
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients presumed to have gram-negative sepsis

Exclusion criteria

Exclusion criteria: -History of allergic reactions attributed to Inj. Sepsivac® or any of its excipients -Pregnant and lactating women -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 eventsTimepoint: 28 days—

Countries

India

Contacts

Public ContactDr Subba Reddy K

Apollo Hospitals

drksreddy77@yahoo.co.in91-9989385110

Outcome results

None listed

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