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Sponsors and Collaborators: |
All India Institute of Medical Sciences, New Delhi Ministry of Science and Technology, India Cadila Pharnmaceuticals |
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Information provided by: | All India Institute of Medical Sciences, New Delhi |
ClinicalTrials.gov Identifier: | NCT00341328 |
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.
Condition | Intervention | Phase |
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Tuberculosis |
Biological: Intradermal injection of Mycobacterium w |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Efficacy and Safety of Immunomodulator (Mycobacterium w.) as an Adjunct Therapy in Category I Pulmonary Tuberculosis and Along With Assessment of Immunological Parameters |
Estimated Enrollment: | 300 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
In one arm the patient will receive intradermal Mycobacterium W Vaccine along with Category I ATT drugs according to RNTCP guidelines
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Biological: Intradermal injection of Mycobacterium w
Mw Vaccine is given as intradermal administration. Total 6 doses are given 0.2 ml at baseline and then 0.1 ml after interval of 2 weeks upto 8 weeks
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2: Placebo Comparator
In this Arm patient will receive Placebo along with Category I ATT drugs according to RNTCP guidelines
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Biological: Intradermal injection of Mycobacterium w
Mw Vaccine is given as intradermal administration. Total 6 doses are given 0.2 ml at baseline and then 0.1 ml after interval of 2 weeks upto 8 weeks
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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.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Patients with abnormal renal function (Serum creatinine more than 1.5 or proteinuria more than 2+
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Seriously ill and moribund patients with complications:
Patients with history of alcohol or drug abuse- to be asked for on history and assessed using the CAGE Questions. The patient should be asked four questions in the following manner. A positive response to any of the following questions will be considered an exclusion criterion.
i. Have you ever felt a need to CUT DOWN your drinking?
ii. Have you ever felt ANGRY when confronted about the amount of alcohol you drink?
iii. Have you ever felt GUILTY when confronted about the amount of alcohol you drink?
iv. Have you ever felt the need to have a drink first thing in the morning? (EYE OPENER).
Contact: Surendra K Sharma, MD,Ph.D | 911126593303 | sksharma@aiims.ac.in |
India | |
Central JALMA Institute of Leprosy and Other Mycobacterial Diseases | Recruiting |
Agra, India, 282001 | |
Contact: Kiran Katoch, M.D. 91562331751-4 ext 224/208 rohinik@sancharnet.in | |
Principal Investigator: Kiran Katoch, M.D. | |
India, Delhi | |
All India Institute of Medical Sciences | Recruiting |
New Delhi, Delhi, India, 110029 | |
Contact: Surendra K Sharma, M.D., Ph.D. 911126593303 sksharma@aiims.ac.in | |
Principal Investigator: Surendra K Sharma, M.D.,Ph.D. |
Study Chair: | Surendra K Sharma, MD, Ph.D. | Professor and Head,Department of Medicine, AIIMS, New Delhi-110029 |
Responsible Party: | All India Institute of Medical Sciences, New Delhi-110029, India ( Head & Professor S K Sharma, Department of Medicine ) |
Study ID Numbers: | CR-01C-1/2003-10, NI-894 |
Study First Received: | June 20, 2006 |
Last Updated: | June 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00341328 History of Changes |
Health Authority: | India: Ministry of Health |
India Pulmonary Tuberculosis Category-I Pulmonary Tuberculosis Immunomodulator Mycobacterium w |
Bacterial Infections Gram-Positive Bacterial Infections Immunologic Factors Respiratory Tract Infections Respiratory Tract Diseases |
Lung Diseases Tuberculosis, Pulmonary Mycobacterium Infections Tuberculosis |
Bacterial Infections Gram-Positive Bacterial Infections Immunologic Factors Respiratory Tract Infections Respiratory Tract Diseases Lung Diseases |
Physiological Effects of Drugs Tuberculosis, Pulmonary Mycobacterium Infections Tuberculosis Pharmacologic Actions Actinomycetales Infections |