Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2025
A 6- to 9-months oral regimen for rifampicin-resistant tuberculosis: a randomized open-label noninferiority trial in China.
СтатьяРандомизированное исследованиеEquivalence TrialНазвание и аннотация: Перевод в очереди
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Sun Feng, Li Yang, Zhang Yilin, Cai Cui, Chen Yuanyuan, Yi Hengzhong, Wu Qianhong, Qian Yuan, Yu Hongying, Lan Yuanbo, Shi Jichan, Huang Ya, Zhang Yungui, Feng Shun, Xiao Mingying, Wang Jing, Li Yiming, He Zebao, Liu Haiqing, Zhang Yena, Chen Yu, Zhou Yong, Li Jinlan, Chen Bin, Xu Lin, Luo Jianfeng, Xing Yajiao, Wei Xiaolin, Zhao Yanlin, Zhang Wenhong, TB-TRUST group
Аннотация
OBJECTIVES: Despite advancements in shorter, oral regimens for drug-resistant tuberculosis, more options are needed to extent patient benefits. We conducted a trial to evaluate the noninferiority of an all-oral regimen compared with the injectable-containing regimen.
METHODS: In an open-label, randomized noninferiority trial in China, participants with rifampicin-resistant pulmonary tuberculosis were assigned 1:1 to a 6- to 9-month all-oral regimen (levofloxacin, linezolid, cycloserine, clofazimine and/or pyrazinamide) and a 9-month injectable-containing control regimen. The primary outcome was a favourable outcome at 84 weeks after treatment initiation, defined by two consecutive, negative cultures with no previous unfavourable outcome, using a noninferiority margin of 10%.
RESULTS: Between 2 June 2020, and 1 December 2021, 660 participants were enrolled and 354 underwent randomization. A total of 312 and 260 participants were included in the modified intention-to-treat and the per-protocol analysis, respectively. In the modified intention-to-treat analysis, 76.1% of participants in the oral group and 63.7% of those in the control group had a favourable outcome at 84 weeks (difference, 12.4%; 95% CI, 2.4-22.5%; noninferiority p < 0.0001). In the per-protocol analysis, 84.4% of participants in the oral group and 73.5% of participants in the control group had a favourable outcome (difference, 10.9%; 95% CI, 1.1-20.7%; noninferiority p < 0.0001). Grade 3 to 5 adverse events occurred in 69.1% of participants in the control group and 59.5% in the oral group. The most common grade 3 to 5 adverse events were QTcF (corrected QT interval calculated with Fridericia's formula) prolongation, affecting 44.6% of participants in the control group and 29.5% of participants in the oral group. Hepatobiliary disorder occurred more frequently in the control group (21.7%) compared with the oral group (7.5%).
CONCLUSIONS: The all-oral regimen was noninferior to the 9-month injectable-containing regimen, offering an alternative for patients lacking access to bedaquiline, delamanid or pretomanid. However, its efficacy against the latest WHO-recommended bedaquiline-containing regimens requires further validation.
METHODS: In an open-label, randomized noninferiority trial in China, participants with rifampicin-resistant pulmonary tuberculosis were assigned 1:1 to a 6- to 9-month all-oral regimen (levofloxacin, linezolid, cycloserine, clofazimine and/or pyrazinamide) and a 9-month injectable-containing control regimen. The primary outcome was a favourable outcome at 84 weeks after treatment initiation, defined by two consecutive, negative cultures with no previous unfavourable outcome, using a noninferiority margin of 10%.
RESULTS: Between 2 June 2020, and 1 December 2021, 660 participants were enrolled and 354 underwent randomization. A total of 312 and 260 participants were included in the modified intention-to-treat and the per-protocol analysis, respectively. In the modified intention-to-treat analysis, 76.1% of participants in the oral group and 63.7% of those in the control group had a favourable outcome at 84 weeks (difference, 12.4%; 95% CI, 2.4-22.5%; noninferiority p < 0.0001). In the per-protocol analysis, 84.4% of participants in the oral group and 73.5% of participants in the control group had a favourable outcome (difference, 10.9%; 95% CI, 1.1-20.7%; noninferiority p < 0.0001). Grade 3 to 5 adverse events occurred in 69.1% of participants in the control group and 59.5% in the oral group. The most common grade 3 to 5 adverse events were QTcF (corrected QT interval calculated with Fridericia's formula) prolongation, affecting 44.6% of participants in the control group and 29.5% of participants in the oral group. Hepatobiliary disorder occurred more frequently in the control group (21.7%) compared with the oral group (7.5%).
CONCLUSIONS: The all-oral regimen was noninferior to the 9-month injectable-containing regimen, offering an alternative for patients lacking access to bedaquiline, delamanid or pretomanid. However, its efficacy against the latest WHO-recommended bedaquiline-containing regimens requires further validation.