Efficacy and Safety of Mycobacterium indicus pranii as an adjunct therapy in Category II pulmonary tuberculosis in a randomized trial
Abstract Prolonged treatment of tuberculosis (TB) often leads to poor compliance, default and relapse, converting primary TB patients into category II TB (Cat IITB) cases, many of whom may convert to multi-drug resistant TB (MDR-TB). We have evaluated the immunotherapeutic potential of Mycobacterium...
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| Format: | Article |
| Language: | English |
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Nature Portfolio
2017-06-01
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| Series: | Scientific Reports |
| Online Access: | https://doi.org/10.1038/s41598-017-03514-1 |
| _version_ | 1818843401273999360 |
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| author | Surendra K. Sharma Kiran Katoch Rohit Sarin Raman Balambal Nirmal Kumar Jain Naresh Patel Kolluri J. R. Murthy Neeta Singla P. K. Saha Ashwani Khanna Urvashi Singh Sanjiv Kumar A. Sengupta J. N. Banavaliker D. S. Chauhan Shailendra Sachan Mohammad Wasim Sanjay Tripathi Nilesh Dutt Nitin Jain Nalin Joshi Sita Ram Raju Penmesta Sumanlatha Gaddam Sanjay Gupta Bakulesh Khamar Bindu Dey Dipendra K. Mitra Sunil K. Arora Sangeeta Bhaskar Rajni Rani |
| author_facet | Surendra K. Sharma Kiran Katoch Rohit Sarin Raman Balambal Nirmal Kumar Jain Naresh Patel Kolluri J. R. Murthy Neeta Singla P. K. Saha Ashwani Khanna Urvashi Singh Sanjiv Kumar A. Sengupta J. N. Banavaliker D. S. Chauhan Shailendra Sachan Mohammad Wasim Sanjay Tripathi Nilesh Dutt Nitin Jain Nalin Joshi Sita Ram Raju Penmesta Sumanlatha Gaddam Sanjay Gupta Bakulesh Khamar Bindu Dey Dipendra K. Mitra Sunil K. Arora Sangeeta Bhaskar Rajni Rani |
| author_sort | Surendra K. Sharma |
| collection | DOAJ |
| description | Abstract Prolonged treatment of tuberculosis (TB) often leads to poor compliance, default and relapse, converting primary TB patients into category II TB (Cat IITB) cases, many of whom may convert to multi-drug resistant TB (MDR-TB). We have evaluated the immunotherapeutic potential of Mycobacterium indicus pranii (MIP) as an adjunct to Anti-Tubercular Treatment (ATT) in Cat II pulmonary TB (PTB) patients in a prospective, randomized, double blind, placebo controlled, multicentric clinical trial. 890 sputum smear positive Cat II PTB patients were randomized to receive either six intra-dermal injections (2 + 4) of heat-killed MIP at a dose of 5 × 108 bacilli or placebo once in 2 weeks for 2 months. Sputum smear and culture examinations were performed at different time points. MIP was safe with no adverse effects. While sputum smear conversion did not show any statistically significant difference, significantly higher number of patients (67.1%) in the MIP group achieved sputum culture conversion at fourth week compared to the placebo (57%) group (p = 0.0002), suggesting a role of MIP in clearance of the bacilli. Since live bacteria are the major contributors for sustained incidence of TB, the potential of MIP in clearance of the bacilli has far reaching implications in controlling the spread of the disease. |
| first_indexed | 2024-12-19T04:57:17Z |
| format | Article |
| id | doaj.art-6a0b4f888de74d3abacaae3ac171d9ed |
| institution | Directory Open Access Journal |
| issn | 2045-2322 |
| language | English |
| last_indexed | 2024-12-19T04:57:17Z |
| publishDate | 2017-06-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | Scientific Reports |
| spelling | doaj.art-6a0b4f888de74d3abacaae3ac171d9ed2022-12-21T20:35:12ZengNature PortfolioScientific Reports2045-23222017-06-017111210.1038/s41598-017-03514-1Efficacy and Safety of Mycobacterium indicus pranii as an adjunct therapy in Category II pulmonary tuberculosis in a randomized trialSurendra K. Sharma0Kiran Katoch1Rohit Sarin2Raman Balambal3Nirmal Kumar Jain4Naresh Patel5Kolluri J. R. Murthy6Neeta Singla7P. K. Saha8Ashwani Khanna9Urvashi Singh10Sanjiv Kumar11A. Sengupta12J. N. Banavaliker13D. S. Chauhan14Shailendra Sachan15Mohammad Wasim16Sanjay Tripathi17Nilesh Dutt18Nitin Jain19Nalin Joshi20Sita Ram Raju Penmesta21Sumanlatha Gaddam22Sanjay Gupta23Bakulesh Khamar24Bindu Dey25Dipendra K. Mitra26Sunil K. Arora27Sangeeta Bhaskar28Rajni Rani29All India Institute of Medical SciencesNational JALMA Institute of Leprosy and Other Mycobacterial Diseases (ICMR)National Institute of Tuberculosis and Respiratory DiseasesNational Institute of Research in Tuberculosis (ICMR)SMS Medical College (Hospital for Chest Diseases and TB)NHL Municipal Medical CollegeMahavir Hospital and Research CentreNational Institute of Tuberculosis and Respiratory DiseasesAll India Institute of Medical SciencesAll India Institute of Medical SciencesAll India Institute of Medical SciencesAll India Institute of Medical SciencesAll India Institute of Medical SciencesAll India Institute of Medical SciencesNational JALMA Institute of Leprosy and Other Mycobacterial Diseases (ICMR)National JALMA Institute of Leprosy and Other Mycobacterial Diseases (ICMR)National JALMA Institute of Leprosy and Other Mycobacterial Diseases (ICMR)NHL Municipal Medical CollegeNHL Municipal Medical CollegeSMS Medical College (Hospital for Chest Diseases and TB)SMS Medical College (Hospital for Chest Diseases and TB)Mahavir Hospital and Research CentreMahavir Hospital and Research CentreCatalyst Clinical Services Pvt. Ltd.Cadila Pharmaceuticals Ltd.Department of BiotechnologyAll India Institute of Medical SciencesPost Graduate Institute of Medical Education & ResearchNational Institute of ImmunologyNational Institute of ImmunologyAbstract Prolonged treatment of tuberculosis (TB) often leads to poor compliance, default and relapse, converting primary TB patients into category II TB (Cat IITB) cases, many of whom may convert to multi-drug resistant TB (MDR-TB). We have evaluated the immunotherapeutic potential of Mycobacterium indicus pranii (MIP) as an adjunct to Anti-Tubercular Treatment (ATT) in Cat II pulmonary TB (PTB) patients in a prospective, randomized, double blind, placebo controlled, multicentric clinical trial. 890 sputum smear positive Cat II PTB patients were randomized to receive either six intra-dermal injections (2 + 4) of heat-killed MIP at a dose of 5 × 108 bacilli or placebo once in 2 weeks for 2 months. Sputum smear and culture examinations were performed at different time points. MIP was safe with no adverse effects. While sputum smear conversion did not show any statistically significant difference, significantly higher number of patients (67.1%) in the MIP group achieved sputum culture conversion at fourth week compared to the placebo (57%) group (p = 0.0002), suggesting a role of MIP in clearance of the bacilli. Since live bacteria are the major contributors for sustained incidence of TB, the potential of MIP in clearance of the bacilli has far reaching implications in controlling the spread of the disease.https://doi.org/10.1038/s41598-017-03514-1 |
| spellingShingle | Surendra K. Sharma Kiran Katoch Rohit Sarin Raman Balambal Nirmal Kumar Jain Naresh Patel Kolluri J. R. Murthy Neeta Singla P. K. Saha Ashwani Khanna Urvashi Singh Sanjiv Kumar A. Sengupta J. N. Banavaliker D. S. Chauhan Shailendra Sachan Mohammad Wasim Sanjay Tripathi Nilesh Dutt Nitin Jain Nalin Joshi Sita Ram Raju Penmesta Sumanlatha Gaddam Sanjay Gupta Bakulesh Khamar Bindu Dey Dipendra K. Mitra Sunil K. Arora Sangeeta Bhaskar Rajni Rani Efficacy and Safety of Mycobacterium indicus pranii as an adjunct therapy in Category II pulmonary tuberculosis in a randomized trial Scientific Reports |
| title | Efficacy and Safety of Mycobacterium indicus pranii as an adjunct therapy in Category II pulmonary tuberculosis in a randomized trial |
| title_full | Efficacy and Safety of Mycobacterium indicus pranii as an adjunct therapy in Category II pulmonary tuberculosis in a randomized trial |
| title_fullStr | Efficacy and Safety of Mycobacterium indicus pranii as an adjunct therapy in Category II pulmonary tuberculosis in a randomized trial |
| title_full_unstemmed | Efficacy and Safety of Mycobacterium indicus pranii as an adjunct therapy in Category II pulmonary tuberculosis in a randomized trial |
| title_short | Efficacy and Safety of Mycobacterium indicus pranii as an adjunct therapy in Category II pulmonary tuberculosis in a randomized trial |
| title_sort | efficacy and safety of mycobacterium indicus pranii as an adjunct therapy in category ii pulmonary tuberculosis in a randomized trial |
| url | https://doi.org/10.1038/s41598-017-03514-1 |
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