The Indian Council of Medical Research–National Institute for Research in Tuberculosis (ICMR-NIRT) has announced a forthcoming multi-centric clinical trial to test high-dose rifampicin-based regimens for drug-sensitive pulmonary tuberculosis (TB). The trial, named PRaCTISe-HR, aims to enhance long-term treatment outcomes and decrease recurrence rates among TB patients in India.

Key highlights

Objective of the clinical trial

• The trial will evaluate recurrence-free survival at 18 months after treatment.

• Aims at treating more than 14-year-old drug-sensitive pulmonary TB, newly diagnosed and retreatment cases.

High-dose Rifampicin Regimen design

• High-dose rifampicin for two or six months, with or without levofloxacin, will be evaluated in the study.

• Aims at reducing TB treatment time from six to four months potentially.

Addressing TB recurrence and resistance

• Even with India's 85–88% TB treatment success rate, 5–10% recurrence rates pose a significant challenge.

• Most relapse patients are mislabeled as "new cases," and the risk of drug-resistant TB is heightened.

Evidence supporting High-dose Rifampicin

• Earlier trials and reviews show that higher rifampicin doses are safe and more effective in culture conversion.

• But its effect on long-term outcomes and prevention of relapse needs to be investigated further.

EoI call for clinical sites

• Clinical trial sites and ICMR-INTENT centers have been asked to send in Expressions of Interest (EoI) by 18th May 2025.

• Shortlisted centers will engage in a nation-level coordinated action to conduct the study.

Study governance and flexibility

• The ICMR holds the rights to modify, withdraw, or reissue the EoI as needed.

• Only shortlisted centers will be approached for collaboration.

The PRaCTISe-HR trial is a landmark attempt to rethink TB care in India by testing high-dose rifampicin approaches that will reduce relapse and drug resistance. As long as TB remains a public health burden, the trial presents a potential avenue for shorter, more efficient treatment supported by national leadership and global applicability.