International Journal of Infectious Diseases (Jul 2023)

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

  • 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

Journal volume & issue
Vol. 132
pp. 99 – 107

Abstract

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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 <0.01). Conclusions: Our study proved that oral faropenem regimen can be used for the treatment of TB, with fewer adverse events. (Chinese Clinical Trial Registry, ChiCTR1800015959).

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