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.
Highlights
After treatment, or have defaulted during previous treatment[2]
We have evaluated the immunotherapeutic potential of Mycobacterium w, renamed as Mycobacterium indicus pranii (MIP) in Cat II Pulmonary TB (Cat II pulmonary TB (PTB)) patients
A total of 1553 Cat II PTB patients were screened of which 531 were screen failure and remaining 1022 were randomized in 1:1 ratio into the two treatment groups
Summary
After treatment, or have defaulted during previous treatment[2]. A significant number of Cat II TB patients have been reported to develop MDR-TB2. It induced conversion from lepromin negativity to lepromin positivity in multibacillary leprosy patients suggesting improved immune response to M. leprae antigens[10] It reduced the bacillary load, upgraded the lesions histopathologically, led to complete clearance of granuloma and reduced the duration of multi-drug therapy in leprosy patients[8]. In a pilot study, addition of MIP to the short course chemotherapy in PTB patients led to earlier sputum conversion by at least 30 days[4] Based on these encouraging results, we conducted a multi-centric trial to evaluate the safety and efficacy of MIP as an adjunct to ATT in Cat II PTB patients registered under the Revised National Tuberculosis Control Programme-Directly Observed Treatment, Short-course (RNTCP-DOTS)
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