PHOENIx (Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients (A5300B/I2003B/) is a Phase III, open-label, multicenter trial 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 among high-risk household contacts (HHCs) of adults (index case) with multidrug-resistant tuberculosis (MDR-TB). This ACTG/IMPAACT cross-network collaboration expects to follow 5610 participants (~2158 index cases and 3452 HHCs) for 96 weeks.
Twenty-seven potential participating sites from 12 countries (Botswana, Brazil, Haiti, India, Kenya, Peru, Philippines, South Africa, Tanzania, Thailand, Uganda, Zimbabwe) are eligible to apply to participate in PHOENIx. Each participating site will have a run-in phase, where the site will demonstrate its capacity to identify adults with MDR-TB (index cases), access their HHs, screen HHCs, and enroll and follow eligible HHCs. While the study opening has been delayed for a number of requested protocol changes, we now anticipate two sites (Botswana: Gabarone/12701 and Brazil: Chagas/12101) opening for enrollment this month, with others to follow.
Congratulations to the PHOENIx’s team persistence and resilience as the study prepares to get underway! PHOENIx is critical to define the best way to prevent TB in contacts of those with MDR-TB and will have profound implications for preventative TB care worldwide.