13^th June, 2022, Beijing                                                                          

Multi drug resistant tuberculosis (MDR-TB) still represents a serious threat to global public health. Treatment success rate of traditional long course regimen (≥18 month) for this disease lingers below 60%. In order to improve the efficacy of MDR-TB treatment in China, led by Dr. Mengqiu Gao, head physician of No. 2 tuberculosis ward of Beijing Chest Hospital, a randomized controlled trial on the effectiveness and safety of a Bedaquiline containing all oral short course regimen among Chinese MDR-TB patients (in short PROSPECT study) has kicked off and started recruiting at 17 centers across China May this year.

PROSPECT is an open label parallel grouping multi-center randomized controlled phase IV clinical study. The study is to assess the effectiveness and safety of a 9 month all oral Bedaquiline containing regimen in comparison with traditional Bedaquiline-free regimens. This new regimen cuts the treatment course (18 months) of traditional regimen in half, will greatly improve the life quality and tolerability of China’s MDR-TB patients if found safe and effective. This study has been carefully designed with protocol developed in strict accordance to the GCP standards. Currently the study has screened 5 patients, and included 1 MDR-TB patient into the study arms. The study is on-going and expected to finish subject recruitment later next year.

Report by Zi Chen, Innovation Alliance