| Autor: |
Yanwan Shangguan, Wanru Guo, Xuewen Feng, Yunzhen Shi, Xiaomeng Li, Zhifen Pan, Ming Hu, Jichan Shi, Cheng Ding, Jiafeng Xia, Wenjuan Hu, Zhongkang Ji, Chengjie Zhao, Yuecui Li, Zebao He, Lingxiao Jin, Xiaodong Tao, Xinming Zhu, Xiaoqiang Zhang, Qun Song, Yuyin Zhu, Lin Zheng, Xiuyuan Jin, Shujuan Huang, Liangxiu Jiang, Yuping Wang, Tiantian Wu, Dan Cao, Ying Zhang, Lanjuan Li, Kaijin Xu |
| Jazyk: |
angličtina |
| Rok vydání: |
2023 |
| Předmět: |
|
| Zdroj: |
International Journal of Infectious Diseases, Vol 132, Iss , Pp 99-107 (2023) |
| Druh dokumentu: |
article |
| ISSN: |
1201-9712 |
| DOI: |
10.1016/j.ijid.2023.04.388 |
| Popis: |
ABSTRACT: Objectives: Faropenem has antituberculosis activity in vitro but its utility in treating patients with tuberculosis (TB) is unclear. Methods: 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%. Results: 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 |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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