Pune part of clinical trial to prevent TB in people exposed to multi-drug resistant cases

India faces serious challenges in the fight against TB and preventing the spread of the disease is critical, said experts with the BJGMC-JHU team.

Pune’s B J Government Medical College (BJGMC) and Johns Hopkins University (JHU) in Baltimore, US, will jointly launch a clinical trial that aims at preventing tuberculosis among family members of multi-drug resistant (MDR) TB patients. At least 300 participants will be enrolled in the trial, which is expected to start by the end of September.

India faces serious challenges in the fight against TB and preventing the spread of the disease is critical, said experts with the BJGMC-JHU team. Nearly half of the world’s MDR-TB cases are reported from India (24 per cent) China (13 per cent) and Russia (10 per cent).

The BJGMC-JHU clinical research team was dedicated towards preventing household spread of TB, Dr Nishi Suryavanshi, deputy director of the Indo-JHU Clinical Research Partnership, told The Indian Express. She said household contacts of TB patients were at particularly high risk of infection.

From 2015 to 2017, a multinational, cross-sectional feasibility study was carried out to assess whether it was possible to reach adult and child household members of MDR-TB patients, evaluate their baseline health, determine HIV status (a known risk factor for TB), and assess their knowledge, attitudes, and perceptions about TB disease, preventive therapy, and participating in research. “Our study team found that household contacts of MDR-TB patients were eager for information about, and therapy for, preventing TB infection,” said Dr Suryavanshi.

Existing treatments for MDR-TB are often toxic and poorly tolerated, according to a statement from the National Institutes of Health, USA.

TB kills more people each year than any other infectious disease and it is essential to prevent latent TB infection from progressing to active MDR-TB disease. A highly effective and preventive TB therapy for vulnerable household members of people with active MDR-TB disease would be a game-changer in TB care, experts with the multi-centre trial have said.

Now, phase III of the Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients (PHOENIx) is being conducted under two trial networks: the AIDS Clinical Trials Group (ACTG) and the International Maternal, Pediatric, Adolescent, AIDS Clinical Trials Network (IMPAACT), and is sponsored by the National Institutes of Health.

It will assess the efficacy and safety of two anti-TB medicines: isoniazid and delamanid. The study will take place at more than 27 sites in 12 countries, including India, Botswana, Brazil, Haiti, Kenya, Peru, the Philippines, South Africa, Tanzania, Thailand , Uganda and Zimbabwe. The study team will enroll over 5,500 participants and the at-risk household members who will be part of the study and will be assigned at random to receive either oral delamanid daily for 26 weeks or oral isoniazid.

“Collaboration and coordination with local government TB programme officials is critical for ensuring transparency and a shared understanding of the study’s purpose, methods, consent process, logistics, and potential implications for India’s national TB control efforts. To that end, our research team recently convened the first PHOENIx study community sensitisation workshop for supervisors of Maharashtra’s TB-control programme, including Dr Padmaja Jogewar, state TB officer, Dr Sudhir Nanadkar, dean of BJGMC, and others,” said Dr Vidya Mave, Indo-JHU clinical research site director.

Dr Mave said the team was eager to begin and if successful, the study would be achieve a breakthrough in efforts to eliminate TB from India.

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