Scientists at ICMR’s National Institute of Research in Tuberculosis have kicked off a multi-centric study to evaluate the efficacy of a 4-month daily regimen for TB treatment using Moxifloxacin, a drug used to prevent the disease as compared to the existing 6-month course.
Under National TB Elimination Program (NTEP), the anti-TB drugs are offered as Fixed-dose combinations (FDC).
As a pilot, researchers analyzed the samples of around 321 sputum samples from TB pulmonary positive in a randomized clinical trial. Based on the experience, the scientists at the institute are now expanding this TB clinical trial to seven sites such as Indira Gandhi Govt. Medical College and Hospital (IGGMCH) in Nagpur, King George's Medical University, Lucknow, Mahavir Hospital and Research Centre, Hyderabad, Govt. Vellore Medical College and Hospital, Adukkamparaiand Lok Nayak hospital, New Delhi.
"We would enroll around 500 TB patients who will receive a four-month regimen, the regular Fixed-dose Combination (FDC) with the Moxifloxacin added on to it, they will get it for four months. Then we will follow them for any relapse, for 24 months after the complete treatment,” Dr Padma Priyadarshini, Director of the ICMR's National Institute for Research in Tuberculosis (NIRT), said adding that the recruitment is ongoing for this study.
“The objective of shortening the treatment is not just cure, but to understand that patient do not have recurrence or relapse of disease. This is the sole objective to shorten the treatment course, Dr Priyadarshini said.
At 2.5 million patients, India has the world’s highest TB burden. The government aims to eliminate the disease by 2025. Although a preventable and treatable disease, stigma remains a big challenge in India.
According to a government report, covid-19 had a major impact on the National TB Elimination Programme (NTEP) because patients either stopped visiting or couldn’t visit hospitals due to the pandemic and lockdown.
As per the health ministry TB prevalence survey (2019-2021), the worst-hit states are Delhi, Rajasthan, Uttar Pradesh, Haryana, and Chhattisgarh.
Last year, the data was captured for 72% of total notified patients, out of which 7% admitted to alcohol usage. Similarly, out of the 74% of the known tobacco usage among all TB patients, 12% of TB patients were reported to be tobacco users. Among those screened, 30% were linked to tobacco cessation services.
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