Efficacy and Safety of Immunomodulator as an Adjunct Therapy in New Pulmonary Tuberculosis(Category I) Patients.

Phase 3

Completed

• Conditions: Tuberculosis
• Interventions: Biological: Intradermal injection of Mycobacterium w

• Registration Number: NCT00341328
• Lead Sponsor: Ministry of Science and Technology, India

Brief Summary

The purpose of the study is to evaluate the efficacy and safety of Mycobacterium w in new lung tuberculosis patients. Mycobacterium w is a strain of bacterium which is being used as vaccine and adjunct drug against leprosy. This agent has also been found to be useful in the treatment of lung tuberculosis in limited number of patients.

We are conducting this study in category-I patients( As per World Health Organization,Geneva classification of tuberculosis) having lung tuberculosis to see the efficacy and also to see any change in the immunological parameters.

Detailed Description

Mycobacterium w is a recently introduced immunomodulator ,which has been found to be useful in rapid killing of Mycobacterium leprae. It improves clearance of Mycobacterium leprae from body and is thereby useful in reducing duration of therapy significantly for multibacillary leprosy. Mycobacterium w shares antigens with Mycobacterium leprae as well as Mycobacterium tuberculosis. Mycobacterium w is also found to be useful in prevention of tuberculosis in experimental animals. Previous studies for efficacy of Mycobacterium w as immunomodulator in pulmonary tuberculosis patients have shown faster sputum conversion rates in patients given Mycobacterium w as an adjuvant therapy along with standard anti-tuberculosis treatment. It has faster and remarkable sputum converting capacity. Similar studies conducted in pulmonary TB category -II \[Re-treatment as per Revised National Tuberculosis Control Programme (RNTCP), Govt. of India\] patients have shown improved cure rates.

Mycobacterium w is commercially available under the brand name of "Immuvac" injection in 0.5 ml multi-dose vials approved for use as immunomodulator against Mycobacterium leprae in patients with leprosy. Each vial has 500 million heat-killed bacilli in a buffered solution. It is manufactured by Cadila Pharmaceuticals Ltd.; Ahmedabad, Gujarat-382 210, India. In this clinical trial one dose consists of 0.1 ml given as intradermal injection, which contains 100 million bacilli. A total of 6 doses are given during the Intensive Phase(as per RNTCP,Ministry of Health and Family Welfare,Govt.of India) of treatment. Two injections on both upper arms on day-0 and subsequently one injection on days 14,28,42 and 56. No injections are given during the Continuation Phase(as per RNTCP,Ministry of Health and Family Welfare,Govt.of India)of treatment.

As of now it is not commercially available for therapeutic use in TB patients as immunomodulator.Therefore we are investigating Mycobacterium w for its efficacy in TB patients in a "double-blind placebo-controlled randomized clinical control trial" fashion. We are conducting this trial in Category-I pulmonary TB Patients(as per RNTCP,Ministry of Health and Family Welfare,Govt.of India),and are assessing the outcome in the form of clinical improvement,sputum conversion and immunological parameters. This is a multi-centric trial sponsored by the Department of Biotechnology, Ministry of Science and Technology, Govt. of India and Cadila Pharmaceuticals Ltd., India.

Study Timeline

• Study First Submitted: 2006-06-20
• Study First Submitted QC: 2006-06-20
• Study First Posted: 2006-06-21
• Study Start: 2007-03
• Primary Completion: 2011-10
• Study Completion: 2012-03
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-25
• Last Update Posted: 2013-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Intradermal injection of Mycobacterium w	In one arm the patient will receive intradermal Mycobacterium W Vaccine along with Category I ATT drugs according to RNTCP guidelines
2	Intradermal injection of Mycobacterium w	In this Arm patient will receive Placebo along with Category I ATT drugs according to RNTCP guidelines

Primary Outcome Measures

Name	Time	Method
The time of sputum conversion as well as the early sputum conversion between the two groups will be evaluated.	from the baseline(visit 2)
The cure rate will be evaluated as the primary parameter of efficacy.	6-7 month
The relapse in patients of category-I pulmonary TB will be compared in both the groups.	at an interval of 6,12,18 and 24 months after the completion of the therapy
Recording of any clinical adverse reactions for assessment of safety.	at anytime during the study

Secondary Outcome Measures

Name	Time	Method
An additional secondary efficacy endpoint is the patient's and physicians's global assessment of the clinical cure.	6-7 month

Trial Locations

Locations (2)

All India Institute of Medical Sciences; 🇮🇳 New Delhi, Delhi, India

Central JALMA Institute of Leprosy and Other Mycobacterial Diseases; 🇮🇳 Agra, India