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
Affiliations
- Yanwan Shangguan
- State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China
- Wanru Guo
- State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China
- Xuewen Feng
- State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China
- Yunzhen Shi
- Department of Infectious Diseases, Affiliated Dongyang Hospital of Wenzhou Medical University, Dongyang, China
- Xiaomeng Li
- State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China
- Zhifen Pan
- Department of Tuberculosis, Jiaxing First Hospital, Jiaxing, China
- Ming Hu
- State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China
- Jichan Shi
- Department of Infectious Diseases, Wenzhou Central Hospital Medical Group, The Dingli Clinical Institute of Wenzhou Medical University, Wenzhou, China
- Cheng Ding
- State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China
- Jiafeng Xia
- State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China
- Wenjuan Hu
- State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China
- Zhongkang Ji
- State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China
- Chengjie Zhao
- Department of Tuberculosis, Jinhua Guangfu Hospital of Zhejiang Province, Jinhua, China
- Yuecui Li
- Department of Infectious Diseases, The First People's Hospital of Yongkang, Yongkang, China
- Zebao He
- Department of Infectious Diseases, Taizhou Enze Medical Center (Group), Enze Hospital, Taizhou, China
- Lingxiao Jin
- Department of Infectious Diseases, People's Hospital of Pujiang County, Jinhua, China
- Xiaodong Tao
- Department of Infectious Diseases, Shaoxing Municipal Hospital, Shaoxing, China
- Xinming Zhu
- Department of Infectious Diseases, Yiwu Central Hospital, Yiwu, China
- Xiaoqiang Zhang
- Department of Infectious Diseases, Yuhang First People's Hospital, Zhejiang Province People's Hospital, Hangzhou, China
- Qun Song
- Department of Infectious Diseases, Huzhou Central Hospital, Affiliated Central Hospital of Huzhou University, Zhejiang University Huzhou Hospital, Huzhou, China
- Yuyin Zhu
- Second Department of Respiratory Diseases, Ningbo No. 2 Hospital, Ningbo, China
- Lin Zheng
- State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China
- Xiuyuan Jin
- State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China
- Shujuan Huang
- State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China
- Liangxiu Jiang
- State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China
- Yuping Wang
- State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China
- Tiantian Wu
- State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China
- Dan Cao
- State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China
- Ying Zhang
- State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China; Correspondence authors: Tel: +86-0571-87236440 (K. Xu); +86-0571-87236458 (L. Li); +86-0571-87236440 (Y. Zhang).
- Lanjuan Li
- State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China; Correspondence authors: Tel: +86-0571-87236440 (K. Xu); +86-0571-87236458 (L. Li); +86-0571-87236440 (Y. Zhang).
- Kaijin Xu
- State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China; Correspondence authors: Tel: +86-0571-87236440 (K. Xu); +86-0571-87236458 (L. Li); +86-0571-87236440 (Y. Zhang).
- Journal volume & issue
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Vol. 132
pp. 99 – 107
Abstract
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).