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Efficacy and Safety of Mycobacterium indicus pranii as an adjunct therapy in Category II pulmonary tuberculosis in a randomized trial.
Sharma, Surendra K; Katoch, Kiran; Sarin, Rohit; Balambal, Raman; Kumar Jain, Nirmal; Patel, Naresh; Murthy, Kolluri J R; Singla, Neeta; Saha, P K; Khanna, Ashwani; Singh, Urvashi; Kumar, Sanjiv; Sengupta, A; Banavaliker, J N; Chauhan, D S; Sachan, Shailendra; Wasim, Mohammad; Tripathi, Sanjay; Dutt, Nilesh; Jain, Nitin; Joshi, Nalin; Penmesta, Sita Ram Raju; Gaddam, Sumanlatha; Gupta, Sanjay; Khamar, Bakulesh; Dey, Bindu; Mitra, Dipendra K; Arora, Sunil K; Bhaskar, Sangeeta; Rani, Rajni.
Afiliação
  • Sharma SK; All India Institute of Medical Sciences, New Delhi, India. surensk@gmail.com.
  • Katoch K; National JALMA Institute of Leprosy and Other Mycobacterial Diseases (ICMR), Agra, India.
  • Sarin R; National Institute of Tuberculosis and Respiratory Diseases, New Delhi, India.
  • Balambal R; National Institute of Research in Tuberculosis (ICMR), Chennai, India.
  • Kumar Jain N; SMS Medical College (Hospital for Chest Diseases and TB), Jaipur, Rajasthan, India.
  • Patel N; NHL Municipal Medical College, Ahmadabad, Gujarat, India.
  • Murthy KJR; Mahavir Hospital and Research Centre, Hyderabad, Andhra Pradesh, India.
  • Singla N; National Institute of Tuberculosis and Respiratory Diseases, New Delhi, India.
  • Saha PK; All India Institute of Medical Sciences, New Delhi, India.
  • Khanna A; All India Institute of Medical Sciences, New Delhi, India.
  • Singh U; All India Institute of Medical Sciences, New Delhi, India.
  • Kumar S; All India Institute of Medical Sciences, New Delhi, India.
  • Sengupta A; All India Institute of Medical Sciences, New Delhi, India.
  • Banavaliker JN; Chest Clinic and Hospital, New Delhi, India.
  • Chauhan DS; All India Institute of Medical Sciences, New Delhi, India.
  • Sachan S; RBTB Hospital, New Delhi, India.
  • Wasim M; National JALMA Institute of Leprosy and Other Mycobacterial Diseases (ICMR), Agra, India.
  • Tripathi S; National JALMA Institute of Leprosy and Other Mycobacterial Diseases (ICMR), Agra, India.
  • Dutt N; National JALMA Institute of Leprosy and Other Mycobacterial Diseases (ICMR), Agra, India.
  • Jain N; NHL Municipal Medical College, Ahmadabad, Gujarat, India.
  • Joshi N; NHL Municipal Medical College, Ahmadabad, Gujarat, India.
  • Penmesta SRR; SMS Medical College (Hospital for Chest Diseases and TB), Jaipur, Rajasthan, India.
  • Gaddam S; SMS Medical College (Hospital for Chest Diseases and TB), Jaipur, Rajasthan, India.
  • Gupta S; Mahavir Hospital and Research Centre, Hyderabad, Andhra Pradesh, India.
  • Khamar B; Mahavir Hospital and Research Centre, Hyderabad, Andhra Pradesh, India.
  • Dey B; Catalyst Clinical Services Pvt. Ltd., New Delhi, India.
  • Mitra DK; Cadila Pharmaceuticals Ltd., Ahmadabad, India.
  • Arora SK; Department of Biotechnology, New Delhi, India.
  • Bhaskar S; All India Institute of Medical Sciences, New Delhi, India.
  • Rani R; Post Graduate Institute of Medical Education & Research, Chandigarh, India.
Sci Rep ; 7(1): 3354, 2017 06 13.
Article em En | MEDLINE | ID: mdl-28611374
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.
Assuntos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Tuberculose Pulmonar / Vacinas de Produtos Inativados / Vacinação / Vacinas contra a Tuberculose Tipo de estudo: Clinical_trials Limite: Adolescent / Adult / Female / Humans / Male / Middle aged Idioma: En Revista: Sci Rep Ano de publicação: 2017 Tipo de documento: Article País de afiliação: Índia

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Tuberculose Pulmonar / Vacinas de Produtos Inativados / Vacinação / Vacinas contra a Tuberculose Tipo de estudo: Clinical_trials Limite: Adolescent / Adult / Female / Humans / Male / Middle aged Idioma: En Revista: Sci Rep Ano de publicação: 2017 Tipo de documento: Article País de afiliação: Índia