Randomized control study of the use of faropenem for treating patients with pulmonary tuberculosis

• Published in: International journal of infectious diseases Vol. 132; pp. 99 - 107
• Main Authors: Shangguan, Yanwan, Guo, Wanru, Feng, Xuewen, Shi, Yunzhen, Li, Xiaomeng, Pan, Zhifen, Hu, Ming, Shi, Jichan, Ding, Cheng, Xia, Jiafeng, Hu, Wenjuan, Ji, Zhongkang, Zhao, Chengjie, Li, Yuecui, He, Zebao, Jin, Lingxiao, Tao, Xiaodong, Zhu, Xinming, Zhang, Xiaoqiang, Song, Qun, Zhu, Yuyin, Zheng, Lin, Jin, Xiuyuan, Huang, Shujuan, Jiang, Liangxiu, Wang, Yuping, Wu, Tiantian, Cao, Dan, Zhang, Ying, Li, Lanjuan, Xu, Kaijin
• Format: Journal Article
• Language: English
• Published: Canada Elsevier Ltd 01.07.2023; Elsevier
• Subjects: Antitubercular Agents; Drug Therapy, Combination; Ethambutol - therapeutic use; Faropenem; Humans; Treatment; Treatment Outcome; Tuberculosis; Tuberculosis, Pulmonary - diagnosis; Tuberculosis, Pulmonary - drug therapy; Tuberculosis; Treatment; Faropenem
• DOI: 10.1016/j.ijid.2023.04.388
• ISSN: 1201-9712

•Faropenem has been proven useful in replacing ethambutol in the standard regimen.•Faropenem regimen showed a similar treatment success rate to the standard regimen.•Faropenem regimen is well tolerated and has fewer adverse events.•Oral β-lactam antibiotic can be a promising antituberculosis candidate. Faropenem has antituberculosis activity in vitro but its utility in treating patients with tuberculosis (TB) is unclear. We conducted an open-label, randomized trial in China, involving newly diagnosed, drug-susceptible pulmonary TB. The control group was treated with the standard 6-month regimen. The experimental group replaced ethambutol with faropenem for 2 months. The primary outcome was the treatment success rate after 6 months of treatment. Noninferiority was confirmed if the lower limit of a 95% one-sided confidence interval (CI) of the difference was greater than −10%. A total of 227 patients eligible for the study were enrolled in the trial group and the control group in a ratio of 1:1. Baseline characteristics of participants were similar in both groups. In the modified intention-to-treat population, 88.18% of patients in the faropenem group achieved treatment success, and 85.98% of those in the control group were successfully treated, with a difference of 2.2% (95% CI, −6.73-11.13). In the per-protocol population, treatment success was 96.04% in the faropenem group and 95.83% in the control group, with a difference of 2.1% (95% CI, −5.31-5.72). The faropenem group showed noninferiority to the control group in the 6-month treatment success rates. The faropenem group had significantly fewer adverse events (P <0.01). Our study proved that oral faropenem regimen can be used for the treatment of TB, with fewer adverse events. (Chinese Clinical Trial Registry, ChiCTR1800015959).