Taking into account strict national and international guidelines for the conduct of clinical trials, ICMR has decided to undertake clinical trials for regulatory submissions and for academic purposes. India is a signatory to the WHO Global Tuberculosis Strategy, which was endorsed by the World Health Assembly in May 2014.
There is a strong need to undertake active research activities to identify new ATT drug regimens, evaluate new drugs, test tuberculosis vaccines and validate new diagnostic tools. The results of the research should be able to guide cost-effective treatment guidelines for local needs and the TB control program.
With the goal of reducing tuberculosis incidence and mortality by 90 percent by 2035 in the country, the Indian Council for Medical Research (ICMR) will soon carry out clinical trials to evaluate drugs and vaccines against tuberculosis.
In this regard, the country's apex research organization invited Letters of Interest (LOI) from public hospitals, medical colleges, research institutions / organizations and private hospitals and practitioners for the conduct of clinical trials Evaluation of TB drugs and vaccines.
The project title of proposed clinical trials included (i) a phase-I, open label, parallel group, pharmacokinetic and efficacy study of rifampicin (450 mg and 600mg) and Piperine (225 mg) compared with standard rifampicin therapy in newly diagnosed sputum positive pulmonary tuberculosis patients as an adjuvant to the standard TB therapy (ii) a phase IIb open label randomized controlled clinical trial to 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 (iii) a double-blind, placebo-controlled comparative study for safety and efficacy of Metformin HCL in combination with ATT as adjunct therapy (iv) a phase–III multicentric open label randomized clinical trial to assess the efficacy and safety of delamanid in combination with bedaquiline, linezolid and clofazimine in participants with XDR-TB (v) inhibition of host-induced mycobacterial efflux pumps as a novel strategy to counter drug tolerance and virulence of pulmonary tuberculosis (vi) a randomized controlled clinical trial on the safety and efficacy of delamanid in the prevention of TB among latent TB infected household contacts of multidrug resistant pulmonary TB patients (vii) early bactericidal activity (EBA) of rifampicin and feropenem in DS –TB patients (viii) salvage regimen for XDR-TB (ix) randomized, controlled, phase II study to evaluate safety, immunogenicity and POD after vaccination in a high risk group (IGRA positive subjects) (x) and an open label safety observational study of inhaled gaseous nitric oxide (gNO) for adults with drug resistant pulmonary tuberculosis.
