The Wadsworth Center, the public health laboratory of the New York State Department of Health, has been selected to serve as the central reference testing laboratory for a major international clinical trial aimed at preventing multidrug-resistant tuberculosis (MDR-TB) in vulnerable populations. The Phase 3 study, known as PHOENIx MDR-TB (Protecting Households on Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients), will evaluate the safety and effectiveness of delamanid, a novel drug developed specifically for MDR-TB, compared to the decades-old standard preventive therapy, isoniazid. The trial focuses on preventing MDR-TB in children, adolescents, and adults at high risk following exposure to infected household members.
The PHOENIx MDR-TB trial is co-funded by the National Institute of Allergy and Infectious Diseases (NIAID) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), both part of the National Institutes of Health (NIH). It is being conducted through two major NIH-supported global research networks: the Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (ACTG) and the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network. The trial spans 30 clinical sites across at least 12 countries, including Botswana, Brazil, Haiti, India, Kenya, Peru, the Philippines, South Africa, Tanzania, Thailand, Uganda, and Zimbabwe.
By serving as the reference laboratory, the Wadsworth Center will provide critical oversight and expertise to ensure consistent, accurate testing across this wide network of global sites. The drug delamanid is being provided by Otsuka Pharmaceutical Co., Ltd. of Tokyo. Delamanid represents one of the first MDR-TB treatment options designed for children, addressing a long-standing gap in care for this vulnerable population. Study investigators hope the trial’s findings will inform global policy and improve prevention strategies for MDR-TB.
The Wadsworth Center’s role in the PHOENIx MDR-TB study underscores New York State’s ongoing commitment to protecting public health at home and abroad.