NIH launches large TB prevention trial for people exposed to multidrug-resistant TB

Dr KK Aggarwal

(NIH): A large phase 3 clinical trial called PHOENIx MDR-TB (Protecting Households on Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients) to assess treatments for preventing people at high risk from developing multidrug-resistant tuberculosis (MDR-TB) has begun.

The study is comparing the safety and efficacy of a new MDR-TB drug, delamanid, with isoniazid, the standard anti-TB drug for preventing active MDR-TB disease in children, adolescents and adults at high risk who are exposed to adult household members with MDR-TB. Study participants include those at high risk for MDR-TB because they either have latent TB infection, immune systems suppressed by HIV or other factors, or are younger than age 5 years and therefore have a weak immune system.

The study investigators hypothesize that prophylactic treatment with delamanid will prove better than isoniazid at reducing the likelihood that at-risk household members of individuals with MDR-TB will develop active TB disease.

“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,” said Anthony S. Fauci, M.D. Director of the National Institute of Allergy and Infectious Diseases (NIAID), which is co-funding the study and is part of the National Institutes of Health.

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA