Title: Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients (PHOENIx MDR-TB)

Lay title: A study comparing the safety and efficacy of two drugs for preventing confirmed or probable active TB among house hold contacts of patients with MDR-TB.

A Phase III, open-label, multicenter trial with a cluster-randomized superiority design (eligible contacts in the same household [HH] are a cluster), to compare the efficacy and safety of 26 weeks of delamanid (DLM) versus 26 weeks of isoniazid (INH) for preventing confirmed or probable active TB during 96 weeks of follow-up among high-risk household contacts (HHCs) of adults with multidrug-resistant tuberculosis (MDR-TB). High-risk HHCs are those with HIV or non-HIV immunosuppression, latent TB infection, and young children below the age of 5 years.

Approximately 5610 (2158 index cases and 3452 household contacts) will be enrolled into the study globally. The Kericho site anticipates to enroll up to 350 participants

Multidrug resistant TB (MDR TB) has been on the rise worldwide with WHO estimating that there were 480000 cases worldwide in the year 2015. MDR TB is of global significance due to associated high mortality rates and toxicity associated with drugs used for treatment. Therefore, there is need to prevent contacts of index cases from contracting the disease

A5300B is a Phase III, open-label, multicenter trial with a cluster-randomized superiority design (eligible contacts in the same HH are a cluster) to compare the efficacy and safety of 26 weeks of DLM versus 26 weeks of INH for preventing confirmed or probable active TB during 96 weeks of follow-up among HIV-infected and other high-risk HHCs of adults with MDR-TB (index case).

The study will enroll adults (≥18 years) with MDR TB and their house hold contacts. Index case is defined as patient with confirmed rifampicin and isoniazid resistance. House hold contacts are individuals who currently lives or lived in the same dwelling unit or plot of land and shares or has shared the same housekeeping arrangements as the index case and who report exposure within 90 days prior to index case starting MDR –TB treatment. The house hold contacts are children aged < 5years of age or adults, adolescents and children aged above 5 years who are LTBI positive.

Globally, a target of 5610 participants will be enrolled (1726 index cases and 3452 contacts) and each participant will remain in the study for a period of 96 weeks. Kericho site anticipates to screen 100 potential index cases to enroll 70 index cases and 280 contacts