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Use of Immunomodulator (Heat Killed Mycobacterium W) in patients admitted with severe infections in ICU, to assess change in SOFA score.

Use of Immunomodulator (Heat killed Mycobacterium W) in early sepsis: A pilot study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/085851
Enrollment
50
Registered
2025-04-28
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

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: Injection Mycobacterium w: Injection of heat killed Mycobacterium w would be given, 0.3 ml intradermal at 3 sites OD for 3 days Control Intervention1: Injection sterile water: Injection

Sponsors

Dr Sanjeev Kumar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients > 18 yrs and < 65 yrs of age, presenting with sepsis

Exclusion criteria

Exclusion criteria: History of allergic reaction, Pregnant and lactating women, Septic skin conditions

Design outcomes

Primary

MeasureTime frame
To see change in SOFA scoreTimepoint: Four days after first dose

Secondary

MeasureTime frame
IL-6 levels, Duration of ICU stay, Mortality Timepoint: Four days after first dose

Countries

India

Contacts

Public ContactDr Ritu Singh

Indira Gandhi Institute of Medical Sciences Patna

ritusingh140@gmail.com8127395753

Outcome results

None listed

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