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

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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Autores principales: 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
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Publicado: Nature Portfolio 2017
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Acceso en línea:https://doaj.org/article/6a0b4f888de74d3abacaae3ac171d9ed
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spelling oai:doaj.org-article:6a0b4f888de74d3abacaae3ac171d9ed2021-12-02T12:31:49ZEfficacy and Safety of Mycobacterium indicus pranii as an adjunct therapy in Category II pulmonary tuberculosis in a randomized trial10.1038/s41598-017-03514-12045-2322https://doaj.org/article/6a0b4f888de74d3abacaae3ac171d9ed2017-06-01T00:00:00Zhttps://doi.org/10.1038/s41598-017-03514-1https://doaj.org/toc/2045-2322Abstract 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.Surendra K. SharmaKiran KatochRohit SarinRaman BalambalNirmal Kumar JainNaresh PatelKolluri J. R. MurthyNeeta SinglaP. K. SahaAshwani KhannaUrvashi SinghSanjiv KumarA. SenguptaJ. N. BanavalikerD. S. ChauhanShailendra SachanMohammad WasimSanjay TripathiNilesh DuttNitin JainNalin JoshiSita Ram Raju PenmestaSumanlatha GaddamSanjay GuptaBakulesh KhamarBindu DeyDipendra K. MitraSunil K. AroraSangeeta BhaskarRajni RaniNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 7, Iss 1, Pp 1-12 (2017)
institution DOAJ
collection DOAJ
language EN
topic Medicine
R
Science
Q
spellingShingle Medicine
R
Science
Q
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
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.
format article
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
title 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_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_sort efficacy and safety of mycobacterium indicus pranii as an adjunct therapy in category ii pulmonary tuberculosis in a randomized trial
publisher Nature Portfolio
publishDate 2017
url https://doaj.org/article/6a0b4f888de74d3abacaae3ac171d9ed
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