The first patients have enrolled in STREAM stage 2 clinical study at a trial site in Mongolia. The trial aims to reduce multidrug-resistant tuberculosis (MDR-TB) treatment from 24 months to 6 or 9 months, and is the first phase III trial to test the effectiveness of bedaquiline within a shortened regimen.
短期處方MDRTB STREAM 試驗第二階段臨床研究在蒙古的試驗中心開始收案，該實驗之目的為將MDR-TB個案的治療時間從24個月減至6或9個月，且是第一個第三期加入bedaquiline的臨床試驗，為測試bedaquiline短期療程療效的研究。
The current treatment standard for MDR-TB involves a complex regimen that not only can last up to 24 months, but also involves frequent and painful injections. This poses a significant burden both for patients and the health systems tasked with administering treatment.
This study will include bedaquiline, produced by Janssen Therapeutics, Division of Janssen Products, LP, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, as part of two additional experimental treatment arms.
The Union, sponsors of the trial, and in collaboration with Janssen, amended the original STREAM study protocol to include an all-oral 9-month regimen and a 6-month regimen, both of which include bedaquiline. The trial’s principal investigators are from the United Kingdom’s Medical Research Council (MRC) and the collaboration is supported by the United States Agency for International Development (USAID).
世界抗癆暨肺疾病聯盟組織(the international Union Against Tuberculosis and Lung Disease) 與楊森製藥公司合作發起該實驗，將原始STREAM研究中9個月治療處方及6個月的治療處方內均加入bedaquiline。該研究主要的研究人員來自英國醫學研究學會，並獲得美國國際開發署的合作支持。
STREAM is the first clinical trial of its kind in Mongolia and several other STREAM countries.
“We hope this study will mark a crucial turning point in the fight against drug-resistant TB,” said I.D. Rusen, Senior Vice President for Research and Development and Union lead for the STREAM Trial. “If successful, the results from Stage 2 will provide further evidence for adopting shorter and more simplified treatment regimens – an essential step in the worldwide effort to confront MDR-TB.”
STREAM 的研究開發副總裁I.D. Rusen表示，「我們期望該研究能成為對抗抗藥性結核病的轉折關鍵。」、「如果實驗成功，該研究結果可以為短程且更簡易的治療處方提供進一步的採用證據，這是全球面對MDR-TB所努力的一個關鍵步驟。」