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ICMR to conduct clinical trials for evaluating tuberculosis drugs and vaccines
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Ramesh Shankar, Mumbai
March 11 , 2017
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Aiming to reduce by 90 per cent the tuberculosis incidence and mortality
by the year 2035 in the country, the Indian Council of Medical Research
(ICMR) will soon conduct clinical trials for evaluating tuberculosis
drugs and vaccines.
In this regard, the apex research
organization in the country has now invited Letter of Interest (LOI)
from government hospitals, medical colleges, research
institutions/organizations and private hospitals and practitioners for
conducting clinical trials for evaluating tuberculosis drugs and
vaccines.
The list of proposed clinical trials included 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; 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; a double-blind,
placebo-controlled comparative study for safety and efficacy of
Metformin HCL in combination with ATT as adjunct therapy; 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; and inhibition of host-induced
mycobacterial efflux pumps as a novel strategy to counter drug tolerance
and virulence of pulmonary tuberculosis.
The list also
included 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; early
bactericidal activity (EBA) of rifampicin and feropenem in DS –TB
patients; salvage regimen for XDR-TB; randomized, controlled, phase II
study to evaluate safety, immunogenicity and POD after vaccination in a
high risk group (IGRA positive subjects); and an open label safety
observational study of inhaled gaseous nitric oxide (gNO) for adults
with drug resistant pulmonary tuberculosis.
India is a signatory
to the WHO Global End TB Strategy, which was approved by the World
Health Assembly in May 2014. The strategy calls for a 90 per cent
reduction in TB incidence and mortality by 2035 and an elimination of
catastrophic health expenditure.
It is evident now that such a
reduction cannot be achieved only with the existing tools &
strategies. There is a strong need to undertake active research
activities so as to identify newer ATT drug regimes, evaluate new drugs,
test TB vaccines and validate new diagnostics tools. The research
results should be able to guide cost effective treatment guidelines for
local needs and the TB control programme.
Keeping in view the
stringent national and international guidelines for conduct of clinical
trials, ICMR has decided to initiate conduct of clinical trials for
regulatory submissions and for academic purposes.
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