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 The Indian Council of Medical Research – National Institute for Research in Tuberculosis (ICMR-NIRT), Chennai, has announced an open call for Expressions of Interest (EoI) from clinical trial sites and INTENT (ICMR Indian Clinical Trial and Education Network) centres to participate in a major multi-centric randomized clinical trial aimed at transforming tuberculosis (TB) treatment in India.
PRaCTISe-HR – A Parallel arm Randomized Clinical Trial is aimed to improve treatment outcomes among persons with drug-sensitive pulmonary TB using high-dose rifampicin regimens, with or without levofloxacin.
Last date to apply for the same is May 18, 2025.
This landmark trial, fully backed by ICMR, will test two key strategies: High-dose rifampicin (RMP) administered for either two or six months along with standard anti-TB drugs and addition of levofloxacin, a fluoroquinolone antibiotic, to potentially shorten treatment duration from six to four months.
The primary objective is to assess recurrence-free survival at 18 months post-randomization among TB patients over the age of 14 with drug-sensitive pulmonary TB (new or previously treated cases). The study targets a critical gap in TB care: reducing recurrence and preventing drug resistance through optimized treatment protocols.
Despite India’s success rate of 85–88% in TB treatment over the past decade, recurrence rates remain significant (5–10%), often within six months of completing treatment. Alarmingly, many of these patients are re-treated as “new cases,” increasing the risk of drug-resistant TB. This trial seeks to address that very issue with scientifically proven interventions.
A recently conducted clinical trial from ICMR-NIRT and systematic reviews published in recent years have documented that high-dose rifampicin is efficacious, and safe than the conventional 10 mg dosage. Studies have also documented that High dose rifampicin containing regimen result in prevention of drug resistance, which is a highly desirable property of an anti-TB regimen. Even though high-doses of rifampicin are found safe and beneficial, with respect to culture conversion, its impact on treatment outcomes and long-term recurrence free survival is unclear. Evidences highlight the need for effective strategies to improve treatment outcomes and reduce TB recurrence in India and use of high-dosage RMP in reducing relapse rates remains to be explored in clinical studies.
Only shortlisted centres will be contacted for further collaboration. Selected researchers will join a coordinated national effort to implement the clinical trial.
ICMR retains the discretion to modify, reissue, or cancel the EoI without notice or liability. Additional updates or amendments to the EoI will be notified as necessary.
This call is a pivotal opportunity for clinical centres to contribute to redefining the future of TB care in India and globally particularly in improving patient outcomes, minimizing recurrence, and curbing drug resistance.
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