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

Phase 2

Completed

• Conditions: Sepsis due to other Gram-negativeorganisms,

• Registration Number: CTRI/2008/091/000292
• Lead Sponsor: CSIR Govt of India

Brief Summary

This study is a randomized double blind, two arms, multicentric, comparative controlled prospective clinical trial of mycobacterium w in combination with standard therapy versus standard therapy alone in sepsis due to gram (-) infections for six month (28 days in each groups) in 72 patients (devide into three groups) that will be conducted in three centers. The primary outcome to determine the 28 days mortality at different dose levels in comparisions to standard therapy. The secondary outcome to observe effacts on organ function and to assess safety and tolerability by determinig the incidence of adverse events in the treatment groups versus control and to observe the effects on serum IL-6,IL-8,TNF-alpha,C3B and CRP levls.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-03
• Last Update Posted: 2019-02-21

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 72

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

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the mortality at different dose levels in comparision to standard therapy.	28 days

Secondary Outcome Measures

Name	Time	Method
Effects on organ function	28 days
Assess safety/tolerability by detyerminig the incidence of adverse events in the treatments group versus control	28 days
Effects on serum IL-6,IL-8, TNF-alpha,C3B and CRP levels	28 days

Trial Locations

Locations (1)

PGIMER; 🇮🇳 Chandigarh, CHANDIGARH, India

PGIMER

🇮🇳Chandigarh, CHANDIGARH, India

Dr Sanjai jain

Principal investigator

911722756677

sanjaivanita@yahoo.com