NIH begins clinical trial to analyze safety, efficiency of new drug for resistant TB

The National Institutes of Health (NIH) recently launched a large clinical trial to investigate the drug delamanid, understanding its safety and efficacy in regards to multidrug-resistant strains of tuberculosis (TB).

Throughout the study, MDR-TB will be compared to the older isoniazid in regards to preventing the disease MDR-TB in children, adolescents, and adults at high risk. Delamanid is one of the first drugs explicitly made for treating MDR-TB, as well as the first made in a child-suitable formula. In 2017 alone, the World Health Organization (WHO) estimates that around 460,000 people developed MDR-TB, which is traditionally treatable through highly toxic and hard-to-tolerate treatments that have only around a 50 percent success rate.

“It is important to perform randomized, controlled clinical trials on how best to provide preventive care for people who come in close contact with individuals with MDR-TB, since this is a major gap in global public health policy,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), said. “This new clinical trial will help fill that gap and hopefully define a way to avert much suffering, disability, and death from MDR-TB.”

This is a phase 3 clinical trial, co-funded by NIAID and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, both parts of NIH. It will be conducted by the AIDS Clinical Trials Group and the International Maternal Pediatric Adolescent AIDS Clinical Trials Network and led by experts from throughout the world. Testing will occur at more than 27 sites in at least 12 countries, with an end goal of around 5,610 participants. Final results are expected sometime in 2024.