A clinical trial to optimize the dose level and evaluate the safety and efficacy potential of drug Mycobacterium w. in Sepsis

Randomized, Double bind, Two arm, Multicentric, Comparative Controlled ,Prospective Clinical trial of Mycobacterium w in combination with satandard therapy versus standard therapy alone in sepsis due to gram(-)ve infections.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2008/091/000292

Enrollment

Registered

2009-04-17

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: mycobacterium W: Group 1:0.1 ml/day consecutive days intra-dermal. Group2:- 0.2 ml/per day(0.1X2) for 3 consucutive days intradermal Group 3:0.3ml/day(0.1X3)for 3 consucutive days intra

Eligibility

Inclusion criteria

Inclusion criteria: Adults of either gender with both margins inclusive(18-65 years) with a diagnosis of Severe systemic gram negative sepsis or septic shock.

Exclusion criteria

Exclusion criteria: Patients with history of allergy,hypersensitivity, or any serious reaction to Mycobacterium w. and with a concomitant medical condition,which may create an unacceptable additional risks

Design outcomes

Primary

Measure	Time frame
To determine the mortality at different dose levels in comparision to standard therapy.Timepoint: 28 days	—

Secondary

Measure	Time frame
Assess safety/tolerability by detyerminig the incidence of adverse events in the treatments group versus controlTimepoint: 28 days;Effects on organ functionTimepoint: 28 days;Effects on serum IL-6,IL-8, TNF-alpha,C3B and CRP levelsTimepoint: 28 days	—

Countries

India

Contacts

Public ContactDr Sanjay Jain

sanjayvanita@yahoo.com911722756677

Outcome results

None listed

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