Journal of Microbiology, Immunology and Infection (Feb 2019)
Safety and efficacy of oral nemonoxacin versus levofloxacin in treatment of community-acquired pneumonia: A phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority trial
- Jinyi Yuan,
- Biwen Mo,
- Zhuang Ma,
- Yuan Lv,
- Shih-Lung Cheng,
- Yanping Yang,
- Zhaohui Tong,
- Renguang Wu,
- Shenghua Sun,
- Zhaolong Cao,
- Jufang Wu,
- Demei Zhu,
- Liwen Chang,
- Yingyuan Zhang,
- Li Zhao,
- Xiongbiao Wang,
- Xuefen Wang,
- Dexi Wang,
- Xiangyang Li,
- Yiqiang Peng,
- Yongjie Liang,
- Hua Liu,
- Zuke Xiao,
- Xiaoju Lv,
- Shiman Wu,
- Yuanrong Dai,
- Yijiang Huang,
- Zhenghong Hu,
- Chen Qiu,
- Xi Li,
- Suiyang Zhang,
- Wenpu Li,
- Shuang Liu,
- Yi Shi,
- Chang Xiong,
- Jiulong Kuang,
- Qingyu Xiu,
- Shehuai Cui,
- Jianguo Li,
- Qichang Lin,
- Wenxiang Huang,
- Yixin Wan,
- Qimanguli,
- Ce Shen,
- Yi Xiao,
- Xiaoju Wu,
- Yin Ching Chuang,
- Wann Cherng Perng,
- Shih-Ming Tsao,
- Jeng-Yuan Hsu,
- Chin-Chou Wang,
- Jen-Hsien Wang,
- Pen-Fang Yeh,
- His-Hsun Lin,
- P.H. Kuo,
- Ming-Shian Lin,
- Wei-Juin Su
Affiliations
- Jinyi Yuan
- Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China; China Key Laboratory of Clinical Pharmacology of Antibiotics, Ministry of Health, Shanghai, China
- Biwen Mo
- Department of Respiratory Medicine, Affiliated Hospital of Guilin Medical University, Guangxi, China
- Zhuang Ma
- Department of Respiratory Medicine, General Hospital of Shenyang Military Area Command, Liaoning, China
- Yuan Lv
- Institute of Clinical Pharmacology, Peking University First Hospital, Beijing, China
- Shih-Lung Cheng
- Department of Internal Medicine, Far Eastern Memorial Hospital, New Taipei City, Taiwan
- Yanping Yang
- Department of Respiratory Medicine, Central Hospital of Jinan, Jinan, China
- Zhaohui Tong
- Department of Respiratory Medicine, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China
- Renguang Wu
- Department of Chest Medicine, Cheng-Ching General Hospital, Taichung, Taiwan
- Shenghua Sun
- Department of Respiratory Medicine, The Third Xiangya Hospital, Central South University, Hunan, China
- Zhaolong Cao
- Department of Respiratory Medicine, Peking University People's Hospital, Beijing, China
- Jufang Wu
- Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China; China Key Laboratory of Clinical Pharmacology of Antibiotics, Ministry of Health, Shanghai, China
- Demei Zhu
- Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China; China Key Laboratory of Clinical Pharmacology of Antibiotics, Ministry of Health, Shanghai, China
- Liwen Chang
- TaiGen Biotechnology Co., Ltd., Taipei, Taiwan
- Yingyuan Zhang
- Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China; China Key Laboratory of Clinical Pharmacology of Antibiotics, Ministry of Health, Shanghai, China; Corresponding author. Institute of Antibiotics, Huashan Hospital, Fudan University, 12 Middle Wulumuqi Road, Shanghai 200040, China. Fax: +86 21 62484347.
- Li Zhao
- Department of Respiratory Medicine, Shengjing Hospital, China Medical University, Liaoning, China
- Xiongbiao Wang
- Department of Respiratory Medicine, Putuo Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China
- Xuefen Wang
- Department of Respiratory Medicine, The First Affiliated Hospital, Zhejiang University, Zhejiang, China
- Dexi Wang
- Department of Respiratory Medicine, Guangzhou Red Cross Hospital, Guangdong, China
- Xiangyang Li
- Department of Respiratory Medicine, Huadong Hospital, Fudan University, Shanghai, China
- Yiqiang Peng
- Department of Respiratory Medicine, Central Hospital of Changsha, Hunan, China
- Yongjie Liang
- Department of Respiratory Medicine, East Hospital, Tongji University, Shanghai, China
- Hua Liu
- Department of Respiratory Medicine, Gansu Provincial People's Hospital, Lanzhou, China
- Zuke Xiao
- Department of Respiratory Medicine, Jiangxi Provincial People's Hospital, Jiangxi, China
- Xiaoju Lv
- Center for Infectious Diseases, West China Hospital, Sichuan University, Chengdu, China
- Shiman Wu
- Department of Respiratory Medicine, The First Affiliated Hospital, Shanxi Medical University, Shanxi, China
- Yuanrong Dai
- Department of Respiratory Medicine, The Second Affiliated Hospital, Wenzhou Medical University, Zhejiang, China
- Yijiang Huang
- Department of Respiratory Medicine, Hainan Provincial People's Hospital, Hainan, China
- Zhenghong Hu
- Department of Respiratory Medicine, Wuhan General Hospital of Guangzhou Command, Wuhan, China
- Chen Qiu
- Department of Respiratory Medicine, People's Hospital of Shenzhen, Guangdong, China
- Xi Li
- Department of Respiratory Medicine, Affiliated Hospital of Hainan Medical University, Hainan, China
- Suiyang Zhang
- Department of Respiratory Medicine, The Second Artillery General Hospital, Beijing, China
- Wenpu Li
- Department of Respiratory Medicine, Hunan Provincial People's Hospital, Hunan, China
- Shuang Liu
- Department of Respiratory Medicine, Beijing Anzhen Hospital, Capital Medical University, Beijing, China
- Yi Shi
- Department of Respiratory Medicine, Nanjing General Hospital, Nanjing, China
- Chang Xiong
- Department of Respiratory Medicine, Taihe Hospital, Hubei University of Medicine, Shiyan, Hubei, China
- Jiulong Kuang
- Department of Respiratory Medicine, The Second Affiliated Hospital, Nanchang University, Jiangxi, China
- Qingyu Xiu
- Department of Respiratory Medicine, Changzheng Hospital, Shanghai, China
- Shehuai Cui
- Department of Respiratory Medicine, Daping Hospital, the Third Military Medical University, Chongqing, China
- Jianguo Li
- Department of Respiratory Medicine, The Second Affiliated Hospital, Zhongshan University, Guangdong, China
- Qichang Lin
- Department of Respiratory Medicine, The First Affiliated Hospital, Fujian medical University, Fujian, China
- Wenxiang Huang
- Department of Infectious Diseases, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China
- Yixin Wan
- Department of Respiratory Medicine, The Second Affiliated Hospital, Lanzhou University, Lanzhou, China
- Qimanguli
- Department of Respiratory Medicine, The First Affiliated Hospital, Xinjiang Medical University, Xinjiang, China
- Ce Shen
- Department of Respiratory Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China
- Yi Xiao
- Department of Respiratory Medicine, Peking Union Medical College Hospital, Beijing, China
- Xiaoju Wu
- Department of Respiratory Medicine, People's Hospital of Wuhan University, Wuhan, China
- Yin Ching Chuang
- Department of Medical Research, Chi Mei Medical Center, Tainan, Taiwan
- Wann Cherng Perng
- Division of Pulmonary Medicine, Department of Internal Medicine, Tri-Service General Hospital, Taipei, Taiwan
- Shih-Ming Tsao
- Division of Chest, Department of Internal Medicine, Chung Shan Medical University Hospital, Taichung, Taiwan
- Jeng-Yuan Hsu
- Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan
- Chin-Chou Wang
- Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan
- Jen-Hsien Wang
- Department of Internal Medicine, Division of Infectious Diseases, China Medical University Hospital, Taipei, Taiwan
- Pen-Fang Yeh
- Cheng Hsin General Hospital, Taipei, Taiwan
- His-Hsun Lin
- Department of Medicine, Section of Infectious Disease, E-Da Hospital, Kaohsiung City, Taiwan
- P.H. Kuo
- Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan
- Ming-Shian Lin
- Department of Internal Medicine, Ditmanson Medical Foundation Chia-Yi Christian Hospital, Chiayi, Taiwan
- Wei-Juin Su
- Department of Chest Medicine, Taipei Veterans General Hospital, Taipei, Taiwan
- Journal volume & issue
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Vol. 52,
no. 1
pp. 35 – 44
Abstract
Background/Purpose: Nemonoxacin is a novel nonfluorinated quinolone with excellent in vitro activity against most pathogens in community-acquired pneumonia (CAP), especially Gram-positive isolates. The purpose of this study was to assess the efficacy and safety of nemonoxacin compared with levofloxacin in patients with CAP. Methods: A phase 3, multicenter, randomized (2:1) controlled trial was conducted in adult CAP patients receiving nemonoxacin 500 mg or levofloxacin 500 mg orally once daily for 7–10 days. Clinical, microbiological response and adverse events were assessed. Non-inferiority was determined in terms of clinical cure rate of nemonoxacin compared with that of levofloxacin in a modified intention-to-treat (mITT) population. NCT registration number: NCT01529476. Results: A total of 527 patients were randomized and treated with nemonoxacin (n = 356) or levofloxacin (n = 171). The clinical cure rate at test-of-cure visit was 94.3% (300/318) for nemonoxacin and 93.5% (143/153) for levofloxacin in the mITT population [difference (95% CI), 0.9% (−3.8%, 5.5%)]. The microbiological success rate was 92.1% (105/114) for nemonoxacin and 91.7% (55/60) for levofloxacin in the bacteriological mITT population [difference (95% CI), 0.4% (−8.1%, 9.0%)]. The incidence of adverse events (AEs) was comparable between nemonoxacin (33.1%, 118/356) and levofloxacin (33.3%, 57/171) (P > 0.05). Conclusion: Nemonoxacin 500 mg once daily for 7–10 days is as effective and safe as levofloxacin for treating adult CAP patients in terms of clinical cure rates, microbiological success rates, and safety profile.ClinicalTrials.gov identifier: NCT01529476. Keywords: Clinical outcome, Community-acquired pneumonia, Levofloxacin, Nemonoxacin, Randomized controlled trial, Safety
