1^th June, 2024, Beijing

Multi drug and rifampicin resistant tuberculosis (MDR/RR-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%. While short course all oral Bedaquiline containing regimens currently recommended by the WHO, such as BPaL and BPaLM are not yet accessible for Chinese patients. One of the major obstacles is safety concerns over Linezolid which is a core component of the regimens mentioned above. In order to improve the accessibility, safety, tolerability as well as outcomes of MDR/RR-TB treatment in China. Led by Dr. Mengqiu Gao, head physician of No. 2 tuberculosis ward of Beijing Chest Hospital, a National Multi-Center Prospective Randomized Clinical Trials on Contizolide Containing All Oral Short Course Chemo-regimens for MDR/RR-TB (C-STAR Study, an investigator-initiated study) has kicked off and started recruiting at 18 centers across China May this year.

Contizolid is a new generation of oxazolidinones which has demonstrated comparable activity against Mtb with better safety profiles in clinical EBA study (comparing to Linezolid). In turn, the agent has been considered for replacing Linezolid in the current WHO recommended short course all oral regimens.

C-STAR is a prospective multi-center open label randomized controlled trial (an investigator-initiated trial). The study is to assess the safety and effectiveness of a 6 month all oral Contizolid (800 mg bid) containing regimen in comparison with a Linezolid (600 mg qd) containing regimen. MDR/RR-TB patients will be stratified according to his/her status of fluroquinolone resistance, and randomized into the study and control arms in a ratio of 1:1. This study has been carefully designed with protocol developed in strict accordance to the GCP standards. The study is on-going and expected to finish subject recruitment later next year.

Report by Zi Chen, Innovation Alliance

Photo by Lin Cong, Beijing Chest Hospital