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ICMR to conduct clinical trial for new drugs regimen for MDR TB

Laxmi Yadav, Mumbai
Monday, February 21, 2022, 08:00 Hrs  [IST]

In a bid to improve treatment outcomes of multidrug-resistant tuberculosis (MDR TB) in the country, the Indian Council of Medical Research will conduct clinical trials for evaluating new TB drugs regimen for MDR TB.

In this regard, the apex research organization in the country has now invited expression of interest (EOI) from government hospitals, medical colleges, research institutions/organizations and private hospitals and practitioners for conducting studies on effectiveness of reduced dosage of Linezolid in modified BPaL (bedaquiline, pretomanid, linezolid regimen with or without MIP (mycobacterium indicus pranii) among MDR TB/rifampicin resistance (RR) patients in India.

MDR TB is caused by an organism that is resistant to at least isoniazid and rifampin, the two most potent TB drugs. These drugs are used to treat all persons with TB disease.

Globally, India bears the burden of the highest prevalence of both TB and MDR TB. MDR TB is especially a public health concern and challenge as the country struggles to meet its ambitious goal of becoming TB-free by 2025. India is a signatory to the WHO Global End TB Strategy, which was approved by the World Health Assembly in May 2014. The strategy called for a 90 per cent reduction in TB incidence and mortality by 2035 and an elimination of catastrophic health expenditure.

Bedaquiline, pretomanid and linezolid regimen (BPaL) is a new regimen shown to have favourable outcomes after six months.

Linezolid, a new antibiotic with activity against mycobacterium tuberculosis, is recommended by the WHO to treat drug resistant tuberculosis as a medicine with “unclear efficacy.”

Several studies suggest that linezolid is poorly tolerated because of the side effects of diarrhoea, constipation, nausea, vomiting, headaches, vision disturbances, flu symptoms, discoloured tongue, and yeast infections. Other side effects include anaemia, peripheral neuropathy, bone marrow suppression and lactic acidosis.

The optimal dosage for linezolid remains unclear. It is generally prescribed at 600 mg daily or twice daily.

To reduce side effects, ICMR has geared up to conduct study on effectiveness of reduced dosage of Linezolid in modified BPaL regimen. It invited application from interested investigators/institutes for participation in the study. The last date for submitting applications is February 22, 2022.


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