ICMR study to assess efficacy of 4-month Tuberculosis treatment regimen underway

CHENNAI: ICMR’s National Institute for Research in Tuberculosis has initiated a study to assess the efficacy of a four-month tuberculosis treatment regimen as compared to the existing six-month regimen.

The trial study is being conducted at five sites — Indira Gandhi Government Medical College and Hospital (IGGMCH) in Nagpur; King George’s Medical University, Lucknow; Mahavir Hospital and Research Centre, Hyderabad; Government Vellore Medical College and Hospital, Adukkamparai; and Lok Nayak Hospital, New Delhi.

The study is being funded by the Indian Council of Medical Research (ICMR).

“As a part of the study, we will be recruiting around 550 tuberculosis (TB) patients who will be getting the four-month treatment regimen, the regular Fixed-dose Combination (FDC) with Moxifloxacin added on to it. We will follow them for relapse for 24 months post treatment,” Dr Padma Priyadarshini, Director, ICMR’s National Institute for Research in Tuberculosis (NIRT) said.

The enrolment is underway at the sites. Delhi and Lucknow sites have started recruiting, while the other sites will be starting soon, she said.

We hope to complete the enrolment by August and follow them up for two years to know the results of whether this shorter treatment works or not. We just have to increase the pace of recruitment in all the sites, she said.

The whole idea of shortening the treatment is just not cure, but to see that the patients do not have recurrence of disease. That is the principle of shortening treatment, Dr Priyadarshini said.

“At present, we are doing the study among adults. We will be following the patients for at least two years and see the occurrence of TB among these patients. Based on the study results, we can then advocate it for every age group,” she said.

The four-month daily regimen containing Moxifloxacin of ICMR-NIRT was studied in 321 sputum positive pulmonary TB patients in a randomised clinical trial in Tamil Nadu a couple of years ago.

Now based on the successful result from that trial, we have upscaled it across the country in five sites, she said.

Under the National Tuberculosis Elimination Programme (NTEP), anti-TB drugs are offered as fixed dose combination (FDC). (PTI)