New TB drug trial starts in Shatabdi Hospital in Mumbai

The hospital is among the nine clinical trial sites across five states in the country that will together recruit 400 patients

A 40-year-old patient is the first to receive pretomanid, new anti-tuberculosis (TB) drug, as a part of a clinical trial commenced at the civic-run Shatabdi Hospital in Govandi, Mumbai, on Tuesday. The hospital is among the nine clinical trial sites across five states in the country that will together recruit 400 patients.

Shatabdi Hospital will recruit 75 patients for the trial. (PHOTO FOR REPRESENTATION)

Pretomanid is the newest anti-TB drug after bedaquiline and delamanid. The drug will be used as a part of three-drug regimen, which includes bedaquiline and another drug called linezolid. This regimen is known as the BPaL regimen.

“A BPaL trial conducted in South Africa has shown promising results, and we believe that this regimen can be a game-changer for a city like Mumbai which has a high burden of drug-resistant cases,” said Dr Vikas Oswal, the principal investigator of the trial at Shatabdi Hospital.

“In the current regimen, these patients take anywhere between 13 and 15 pills a day and the treatment course goes on for 18-24 months. In BPaL regimen, the patients effectively take three pills for a period of six months. We will be working with different dosages under the trial,” he said, adding that a patient –a 25-year-old man in the pre-XDR (extensively drug-resistant) phase – has also given consent and is likely to start the regimen in a day or two.

Shatabdi Hospital will recruit 75 patients for the trial. These patients will be in the pre- XDR phase or in the multi-drug resistant (MDR) phase with failed drug outcomes. Other trial sites include Savoday Hospital in Ghatkopar, King George’s Medical University in Lucknow, SN Medical College in Agra, BJ Medical College in Ahmedabad, Government Medical College in Surat, National Institute of TB and Respiratory Diseases and Rajan Babu Institute of Pulmonary Medicine and Tuberculosis (RBIPMT), Delhi, and Government Rajaji Hospital, Madurai.