Efficacy and Safety of Mycobacterium indicus pranii as an adjunct therapy in Category II pulmonary tuberculosis in a randomized trial View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2017-12

AUTHORS

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

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. More... »

PAGES

3354

Identifiers

URI

http://scigraph.springernature.com/pub.10.1038/s41598-017-03514-1

DOI

http://dx.doi.org/10.1038/s41598-017-03514-1

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1085916368

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/28611374


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