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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: | NCT00265226 |
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.
Condition | Intervention | Phase |
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Tuberculosis |
Biological: Intra-dermal administration 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 Study of Immunomodulator (Mycobacterium w) as an Adjunct Therapy in Category-II Pulmonary Tuberculosis Along With Assessment of Immunological Parameters |
Estimated Enrollment: | 1020 |
Study Start Date: | March 2005 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (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 II ATT according to RNTCP guidelines
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Biological: Intra-dermal administration of Mycobacterium w
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
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2: Placebo Comparator
In this Arm patient will receive Placebo along with Category II ATT drugs according to RNTCP guidelines
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Biological: Intra-dermal administration of Mycobacterium w
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
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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 the clearance of Mycobacterium leprae from the body and is thereby useful in reducing the duration of therapy significantly for multibacillary leprosy. Mycobacterium w shares an antigen with both Mycobacterium leprae as well as Mycobacterium tuberculosis. Mycobacterium w is also found to be useful in the prevention of tuberculosis in experimental animals.
Previous studies on the efficacy of Mycobacterium w as an immunomodulator in pulmonary tuberculosis patients have shown higher 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 0.5 x 10^9 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 an intradermal injection, which contains 10^9 bacilli. A total of 6 doses are given during the Intensive Phase (as per RNTCP, 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, Govt. of India) of treatment.
As of now, it is not commercially available for use in TB patients as an immunomodulator. Therefore, we are investigating Mycobacterium w (Mw) for its efficacy in TB patients in a "double-blind placebo-controlled randomized clinical control trial" fashion. We are conducting this trial in Category-II pulmonary TB patients (as per RNTCP, 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:
Contact: Surendra K Sharma, M.D., Ph.D. | 911126593303 | sksharma@aiims.ac.in |
India, Andhra Pradesh | |
Mahavir Hospital | Recruiting |
Hyderabad, Andhra Pradesh, India, 500004 | |
Contact: K J Murthy, M.D. 914027564242 jmrkulluri@hotmail.com | |
Principal Investigator: K J Murthy, 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. | |
Lala Ram Swarup Institute of Tuberculosis and Respiratory Diseases | Recruiting |
New Delhi, Delhi, India, 110030 | |
Contact: Vijay Arora, M.D. 911126854922 vk_raksha@vsnl.in | |
Contact: Neeta Singla, M.D. 911126854929 drneetasingla@rediffmail.com | |
Principal Investigator: Vijay Arora, M.D. | |
Sub-Investigator: Neeta Singla, M.D. | |
India, Gujarat | |
Smt NHL Municipal Medical College & B.J. Medical College | Recruiting |
Ahmedabad, Gujarat, India, 380006 | |
Contact: Naresh R Patel, M.D. 919824011509 sharvarinaresh@yahoo.com | |
Contact: Kusum Shah, M.D. drkusumshah@indiatimes.com | |
Principal Investigator: Naresh R Patel, M.D. | |
India, Karnataka | |
National Tuberculosis Institute | Recruiting |
Bangalore, Karnataka, India, 560 003 | |
Contact: Prahlad Kumar, M.D. 918023362431 P_kumar@hotmail.com | |
Principal Investigator: Prahlad Kumar, M.D. | |
India, Rajasthan | |
SMS Medical College | Recruiting |
Jaipur, Rajasthan, India | |
Contact: N K Jain, M.D. 911412280348 jainnadr@yahoo.co.in | |
Principal Investigator: N K Jain, M.D. | |
India, Tamilnadu | |
Tuberculosis Research Centre | Recruiting |
Chennai, Tamilnadu, India, 600 031 | |
Contact: Rajeshwari Ramachandran 91442836 2525 rajerama@yahoo.com | |
Principal Investigator: Rajeshwari Ramachandran, M.D. | |
India, Uttar Pradesh | |
Central JALMA Institute of Leprosy | Recruiting |
Agra, Uttar Pradesh, India, 282001 | |
Contact: Kiran Katoch, M.D. 915622331751 ext 224 rohinik@sancharnet.in | |
Principal Investigator: Kiran Katoch, M.D. |
Study Chair: | Surendra K Sharma, M.D., Ph.D. | Professor and Head, Department of Medicine, All India Institute of Medical Sciences, New Delhi, India |
Responsible Party: | All India Institute of Medical Sciences ( Dr. S K Sharma ) |
Study ID Numbers: | CR-01A/2003-10, NI-705 |
Study First Received: | December 13, 2005 |
Last Updated: | December 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00265226 |
Health Authority: | India: Ministry of Health |
India Pulmonary Tuberculosis Category-II tuberculosis Immunomodulator |
Mycobacterium w Revised National Tuberculosis Control Programme Category-II Pulmonary Tuberculosis |
Bacterial Infections Gram-Positive Bacterial Infections Respiratory Tract Infections Respiratory Tract Diseases Tuberculosis, pulmonary |
Lung Diseases Tuberculosis, Pulmonary Mycobacterium Infections Tuberculosis |
Actinomycetales Infections |