CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,020 enrolled
Drug / intervention
Intra-dermal administration of Mycobacterium wbiological
Likely dose
Intra-dermal administration of Mycobacterium w 0.2 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00265226
NCT00265226Phase 3Completed
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Efficacy and Safety Study of Immunomodulator (Mycobacterium w) as an Adjunct Therapy in Category-II Pulmonary Tuberculosis Along With Assessment of Immunological Parameters

Ministry of Science and Technology, India·interventional·Posted Dec 14, 2005·Updated Jan 6, 2014

In Brief

A Phase 3 clinical trial evaluating Intra-dermal administration of Mycobacterium w for Tuberculosis. Completed, enrolled 1,020 participants across 8 sites.

Detailed Summary

The purpose of the study is to study the efficacy and safety of Mycobacterium in treating patients with lung tuberculosis . Mycobacterium is a strain of bacterium which is used as a vaccine and an adjuvant drug against leprosy. This agent has also been found to be effective in the treatment of lung tuberculosis in a limited number of patients. The researchers are conducting this study in the World Health Organization (WHO) category-II of lung tuberculosis patients to see the efficacy and also to see any change in immunological parameters.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberculosis
CountriesIndia
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 14, 2005
Enrollment StartMar 1, 2005
Primary CompletionDec 1, 2010
Study CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 20.6 years ago

Interventions

Intra-dermal administration of Mycobacterium wbiological

Mw Vaccine is given as oral suspension. Total 6 doses are given 0.2 ml at baseline and then 0.1 ml after interval of 2 weeks upto 8 weeks