Tuberculosis Clinical Trial
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
Verified date | July 2011 |
Source | Ministry of Science and Technology, India |
Contact | n/a |
Is FDA regulated | No |
Health authority | India: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1020 |
Est. completion date | March 2011 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Patients who are sputum positive for pulmonary tuberculosis and who have been treated previously for more than 1 month as per the RNTCP/WHO guidelines. - Category II inclusion will mean all those patients who are Treatment after Default/Treatment Failure/Treatment Relapse. - Patients who are willing to give written informed consent. Exclusion Criteria: - Patients who are known to be hypersensitive to those ATTs being administered. - Patients co-infected with HIV, hepatitis B or hepatitis C. - Pregnant and lactating females or females of child bearing age with a urine HCG positive result 24-48 hours prior to every injection of Mw till 8 weeks. - Patients with abnormal renal function, liver function or hematological tests. - Seriously ill and moribund patients with complications such as low lung reserve, marked tachypnoea, chronic cor pulmonale, congestive heart failure. - Severely malnourished patients with body mass index (BMI) < 15 - Severe hypoalbuminemia. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
India | Central JALMA Institute of Leprosy | Agra | Uttar Pradesh |
India | Smt NHL Municipal Medical College & B.J. Medical College | Ahmedabad | Gujarat |
India | National Tuberculosis Institute | Bangalore | Karnataka |
India | Tuberculosis Research Centre | Chennai | Tamilnadu |
India | Mahavir Hospital | Hyderabad | Andhra Pradesh |
India | SMS Medical College | Jaipur | Rajasthan |
India | All India Institute of Medical Sciences | New Delhi | Delhi |
India | Lala Ram Swarup Institute of Tuberculosis and Respiratory Diseases | New Delhi | Delhi |
Lead Sponsor | Collaborator |
---|---|
Ministry of Science and Technology, India |
India,
Katoch K, Katoch VM, Natrajan M, Bhatia AS, Sreevatsa, Gupta UD, Sharma VD, Shivannavar CT, Patil MA, Bharadwaj VP. Treatment of bacilliferous BL/LL cases with combined chemotherapy and immunotherapy. Int J Lepr Other Mycobact Dis. 1995 Jun;63(2):202-12. — View Citation
Khatri GR, Frieden TR. Controlling tuberculosis in India. N Engl J Med. 2002 Oct 31;347(18):1420-5. — View Citation
Patel N, Deshpande MM, Shah M. Effect of an immunomodulator containing Mycobacterium w on sputum conversion in pulmonary tuberculosis. J Indian Med Assoc. 2002 Mar;100(3):191-3. — View Citation
Patel N, Trapathi SB. Improved cure rates in pulmonary tuberculosis category II (retreatment) with mycobacterium w. J Indian Med Assoc. 2003 Nov;101(11):680, 682. — View Citation
Sharma P, Kar HK, Misra RS, Mukherjee A, Kaur H, Mukherjee R, Rani R. Disabilities in multibacillary leprosy following multidrug therapy with and without immunotherapy with Mycobacterium w antileprosy vaccine. Int J Lepr Other Mycobact Dis. 1999 Sep;67(3):250-8. — View Citation
Sharma P, Kar HK, Misra RS, Mukherjee A, Kaur H, Mukherjee R, Rani R. Induction of lepromin positivity following immuno-chemotherapy with Mycobacterium w vaccine and multidrug therapy and its impact on bacteriological clearance in multibacillary leprosy: report on a hospital-based clinical trial with the candidate antileprosy vaccine. Int J Lepr Other Mycobact Dis. 1999 Sep;67(3):259-69. — View Citation
Sharma P, Kar HK, Misra RS, Mukherjee A, Kaur H, Mukherjee R, Rani R. Reactional states and neuritis in multibacillary leprosy patients following MDT with/without immunotherapy with Mycobacterium w antileprosy vaccine. Lepr Rev. 2000 Jun;71(2):193-205. — View Citation
Sharma P, Misra RS, Kar HK, Mukherjee A, Poricha D, Kaur H, Mukherjee R, Rani R. Mycobacterium w vaccine, a useful adjuvant to multidrug therapy in multibacillary leprosy: a report on hospital based immunotherapeutic clinical trials with a follow-up of 1-7 years after treatment. Lepr Rev. 2000 Jun;71(2):179-92. — View Citation
Sharma P, Mukherjee R, Talwar GP, Sarathchandra KG, Walia R, Parida SK, Pandey RM, Rani R, Kar H, Mukherjee A, Katoch K, Benara SK, Singh T, Singh P. Immunoprophylactic effects of the anti-leprosy Mw vaccine in household contacts of leprosy patients: clinical field trials with a follow up of 8-10 years. Lepr Rev. 2005 Jun;76(2):127-43. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The time of sputum conversion as well as the early sputum conversion between the 2 groups will be evaluated. | from baseline (visit 2) | Yes | |
Primary | The cure rate will be evaluated as the primary parameter of efficacy. | 8-9 months | Yes | |
Primary | The relapse in patients of category II tuberculosis will be compared in both the groups. | at an interval of 6, 12, 18 and 24 months after the completion of the therapy | Yes | |
Primary | Recording of any clinical adverse reactions at anytime during the study for assessment of safety | 2-8 weeks | Yes | |
Secondary | An additional secondary efficacy endpoint is the patient's and physician's global assessment of the clinical cure. | 8-9 months | Yes |
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