The STREAM trial Sponsor and Chief Investigators acknowledge the decision of the South African Government to offer all South African patients with multi-drug resistant tuberculosis (MDR-TB) an injectable-free regimen. While we believe STREAM’s ongoing evaluation of an all-oral regimen, as well as the safety of Bedaquiline in a late phase clinical trial, remain very relevant for the field, we fully respect the autonomy of national programs to implement the treatment guidelines they believe are most appropriate in their setting. The trial will stop enrolling patients in South African sites when this policy is implemented at any given site, but will continue treatment and careful follow-up for all consenting patients already enrolled in the trial in accordance with the protocol.
In STREAM sites outside of South Africa, the trial will continue to randomize patients (consistent with local treatment practices), to allow a timely completion of recruitment and generation of crucial evidence to guide future national and global MDR-TB treatment policy.
Read more about the STREAM trial in South Africa.