Chennai: Amidst mounting international pressure to bring down the Tuberculosis (TB) burden in the country, the Indian Council for Medical Research has decided to conduct clinical trials for evaluating current vaccines and drugs.
As India is part of World Health Organisation’s (WHO) Global End TB Strategy, it is required to have a 90 per cent reduction in TB incidence and mortality by 2035. With this in mind, ICMR has roped in government hospitals, medical colleges, research institutes and practitioners to ensure the trials are conducted at a fast pace.
Stating that such a reduction cannot be achieved with only the existing tools and strategies of the government, a senior ICMR official in a recent report had said that there is a strong need to undertake active research activities so as to identify newer anti-tuberculosis treatment (ATT) drug regimes, evaluate new drugs, test TB vaccines, and validate new diagnostics tools.
The trials, which are expected to begin soon, will be divided into three phases. “The first phase will focus on the efficacy study of rifampicin (450mg and 600mg) and piperine (225mg) as compared to the standard rifampicin therapy in newly diagnosed sputum positive pulmonary tuberculosis patients as an adjuvant to the standard TB therapy. The second phase, on the other hand, will evaluate the safety, tolerability, pharmacokinetics and anti-bacterial activity of high dose rifampicin when given along with other anti-TB drugs in adults with newly diagnosed pulmonary tuberculosis,” said an ICMR official, adding that the third phase will assess the efficacy and safety of delamanid in a combination with bedaquiline, linezolid and clofazimine in participants with XDR-TB.
“These trials in which we are trying to alter the course of samples, may take some time coming up. Our aim is to see if the increased dosage is more effective than the regular ones,” said Dr Mohan Natarajan, head of the clinic Department, National Institute for Research in Tuberculosis, Chennai.
Stating that TB Trials Consortium formed for conducting research will ensure that the trials go on faster, he said that the various institutes that have been roped in for the cause would work towards ensuring the same.
“It is a very good initiative by ICMR. Involving all stakeholders if he fight against TB was essentially the need of the hour,” said a government hospital
doctor.
