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Research Update: TB Trials Conducted by JHU-India Team Will Shorten Drug-Susceptible TB Treatment for Children and Adults
Reporting from the virtual 51st Union Conference on Lung Health, the World Health Organization (WHO) and the U.S. Centers for Disease Control and Prevention (CDC) announced promising findings from 2 tuberculosis trials in which the JHU-India Clinical Research partnership in Pune contributed.
SHINE Trial Offers Shorter Course TB Treatment in Children
The WHO Global TB Programme announced that the Phase 3 SHINE Trial (Shorter Treatment for Minimal Tuberculosis in Children) found that a shortened 4-month regiment of rifampicin, isoniazid, pyrazinamide plus or minus ethambutol in children with smear-negative, non-severe TB was noninferior to the standard 6-month treatment, with no difference in adverse events. These findings have the potential to change current treatment guidelines for children with drug-susceptible TB. The JHU-India Clinical Research partnership enrolled 86 participants in this important trial.
The WHO notes “Long treatment regimens can result in high costs to families and health services, potentially with added toxicity, risks of drug-drug interactions in children living with HIV, and problems with pill-burden and adherence.” JHU-India Clinical Research Partnership Director Dr. Vidya Mave was PI for the effort in India: “India assumes the world’s largest burden of tuberculosis, and the treatment is prolonged and difficult—particularly for children. Our team is proud to have contributed to findings that shorten the length of treatment, and we are grateful to the families who participated in this important effort.”
Congratulations to the JHU-India SHINE Team, led by:
• Dr. Vidya Mave, JHU Pune Principal Investigator
• Dr. Aarti Kinikar, BJGMC Principal Investigator
• Dr. Priyanka Richur, Study Coordinator
• Dr. Mandar Paradkar
• Savita Kanade
• Aparna Nijampurkar
Learn more about the SHINE Trial methodology and findings from the WHO:
Study 31/A5349: Four Month Course of Daily TB Treatment Is as Effective as 6-Months in Adults
In another important finding, the CDC announced the results of a Phase 3 trial that found that a daily regimen of high-dose rifapentine with moxifloxacin administered over 4-months is as effective as the current 6-month standard of care. With no difference in adverse events, the shortened treatment is just as safe. Study 31/A5349 enrolled more than 2,500 participants from clinical sites in 13 countries, including the JHU-India Clinical Research Site in Pune, India, where 61 participants were enrolled. The study represents the largest drug-susceptible TB treatment trial ever conducted by CDC or NIAID.
Congratulations to team members Dr. Vidya Mave, Dr. Sanjay Gaikwad, Dr. Nishi Suryavanshi, Dr. Neetal Nevrekar, Dr. Sandesh Patil, Vandana Kulkarni, Neeta Pradhan, Savita Kanade, Sadaf Inamdar, Sameer Khan, and Smita Nimkar for contributing to this landmark international effort.
Learn more about Study 31/A5349 methodology and findings from CDC: