The Pan India Distribution of Pneumococcal Serotypes Study or the PIDOPS Study has identified the bacteria responsible for pneumococcal disease in Indian children below 5 years. It has also portrayed an alarming trend of 11 per cent, 32 per cent, 48 per cent drug resistance observed for penicillin, erythromycin and co-trimoxazole respectively.
In the first 8 months of 2015, India reported for 1.2 million under-5 child fatalities of which around 2.8 lakhs succumbed to pneumonia. Of these, 1.2 lakh deaths were due to pneumococcal bacteria.
A matter of great concern is multi drug resistance observed in 26per cent of the isolates which may result in greater mortality and morbidity, Dr K L Ravi Kumar, Professor Emeritus-Microbiology, Kempegowda Institute of Medical Sciences, Bangalore, and Principal investigator, PIDOPS, told Pharmabiz in an email.
The other key findings in the PIDOPS is the burden of pneumococcal infection in children with pneumonia which is reported to be very high at 32 per cent. Serotype 1, 6B, 14, 23F and 19F are the most common and 3, 6A and 19A which is present only in 13 valent vaccine accounted for 10 per cent of the isolates. The 13 valent vaccine available in the Indian market covers and provides protection against 81 per cent of isolates. The use of molecular techniques for surveillance studies in addition to conventional methods provided faster, economical, specific and reliable data, he added.
However, there is a need to conduct long term invasive pneumococcal disease (IPD) surveillance studies covering different geographical areas with standard protocol, noted Dr. Kumar.
KIMS, Bengaluru was the main centre of the study along with six institutional and 51 sentinel sites spread across the country. The study was sponsored by a leading pharmaceutical company. The Phase 1 of the study was conducted in 7 centres at Bengaluru, Chennai, Jodhpur, Ludhiana, Delhi, Kolkata and Kanpur, besides 51 sentinel centres making it a total of 58 centres. Blood and serum samples collected from 1504 clinically suspected children from Bangalore, Chennai, Jodhpur, Delhi, Ludhiana, Kolkata and Kanpur. The study concluded that Pneumococcal Conjugate Vaccine 13 (PCV 13) provided 81 per cent protection cover from pneumonia which was 8 per cent more compared to the closest effective pneumonia vaccine.
For this study, an innovative methodology: PCR seq typing which is a molecular methodology was used for identification of infection and serotyping of pneumococci simultaneously for the 91 serotypes even in the culture negative clinical samples. These findings are now being presented at the World Society for Pediatric Infectious Diseases (WSPID) Reo de Janerio, Brazil, held between November 18 to 21 2015.
Dr. Kumar intends to extend the PIDOPS research study to every state in India. Phase 2 of the PIDOPS Study would be conducted across 165 centres covering 15 Institutional+150 sentinel sites for a 2 year duration starting from December 2015. He also plans to increase the sample size from 1500 to 5,000.
Conventional culture method used for identifying pneumococcal bacteria is insensitive, serotyping test and drug resistance testing by accurate minimum inhibitory concentration method are expensive and available in very few centres in the country. Hence there is an urgent need to build research work and establish referral centres in India and other developing countries. The action plan is to disseminate the findings to researchers, doctors, administrators and policy makers through publications, seminars, conferences and direct communication, said Dr. Kumar.