A5300B

Protecting Households on Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Participants (PHOENIx).

Protocol summary:

This trial is of household contacts (HHC) at high risk for developing multidrug resistant tuberculosis (MDR-TB) which is an infection that does not get better with standard treatment for TB.  HHC means any person that lives with, has lived with, or shared housekeeping duties in a home or the same place with a person (an Index Case) who has pulmonary MDR-TB (a lung infection or pneumonia with TB) and started treatment for MDR-TB within the past 90 days. It is also for people who have spent more than 4 hours indoors with the index case, during the week before they started MDR-TB treatment. High-risk household contacts are those with HIV or an immune system problem not from HIV like cancer, latent TB infection (a history of TB infection in the past based on testing), and young children below the age of 5 years. The purpose of this Study: Is to compare how safe and effective 26 weeks of Delamanid (DLM), a medicine used to treat TB, is versus 26 weeks of isoniazid (INH), a standard medicine to treat or prevent TB, for preventing infection with TB (latent TB) or confirmed or probable active infection with TB among participants high risk HHC.

ACTG

Current Study

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