This week, Stage 2 of the STREAM Clinical Trial reached a significant milestone when it recruited its 400th patient. STREAM Stage 1 and Stage 2 have now recruited more than 800 patients combined, making STREAM the largest recruited trial for multidrug-resistant tuberculosis (MDR-TB).
The 400th patient was recruited to STREAM Stage 2 at the BJMC site in India. Stage 2 of the trial is evaluating the safety and efficacy of an all-oral, shortened regimen for MDR-TB. The trial compares a nine-month all-oral bedaquiline-containing regimen to a nine-month regimen containing an injectable that carries the risk of serious side effects, including permanent hearing loss and renal impairment. Stage 2 began recruiting participants in 2016 and is currently taking place at 12 sites in seven countries (Ethiopia, Georgia, India, Moldova, Mongolia, South Africa and Uganda), with preliminary results expected in 2021.
STREAM participants were initially recruited to four arms of the trial. Participants in Arm A received the 20-month regimen, while those in Arm B received a shortened nine-month regimen containing an injectable. Trial participants in Arm C received a nine-month, all-oral regimen that includes bedaquiline, and those in Arm D received a six-month regimen with an injectable.
Since STREAM began in 2012 the MDR-TB landscape has evolved significantly, and STREAM has been able to evolve to focus on providing the most relevant evidence for the treatment of MDR-TB. At the start of the trial, the standard of care for MDR-TB was a 20-24-month regimen known to cause significant side effects. Bedaquiline, one of the newest TB drugs, was initially available only for pre-extensively drug resistant tuberculosis and extensively drug resistant tuberculosis. It is now, however, increasingly available to treat MDR-TB through National TB Programs. In June 2018, South Africa’s National Tuberculosis Program was the first to announce its intention to phase out an injectable-containing treatment as the standard of care for MDR-TB, replacing it with an all-oral regimen that includes bedaquiline. This transition has important implications for the conduct of the trial.
In response to the changing landscape for MDR-TB treatments, STREAM has now halted recruitment to Arms A and D, while continuing recruitment to Arms B and C in most countries. This will enable Stage 2 to focus recruitment on the two remaining Arms and deliver evidence regarding the most relevant treatment regimen – the all-oral, shorter regimen. Recruitment to Arms B and C will continue until at least September 2019.
STREAM remains focused on contributing the highest quality evidence regarding better MDR-TB regimens, not only to support future policy making but also to improve outcomes for people living with MDR-TB.
To read more about the STREAM Trial, click here.