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
机构：[a]Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China[b]China Key Laboratory of Clinical Pharmacology of Antibiotics, Ministry of Health, Shanghai, China[c]Department of Respiratory Medicine, Affiliated Hospital of Guilin Medical University, Guangxi, China[d]Department of Respiratory Medicine, General Hospital of Shenyang Military Area Command, Liaoning, China[e]Institute of Clinical Pharmacology, Peking University First Hospital, Beijing, China[f]Department of Internal Medicine, Far Eastern Memorial Hospital, New Taipei City, Taiwan[g]Department of Respiratory Medicine, Central Hospital of Jinan, Jinan, China[h]Department of Respiratory Medicine, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China内科系统(本部)呼吸科（本部）北京朝阳医院[i]Department of Chest Medicine, Cheng-Ching General Hospital, Taichung, Taiwan[j]Department of Respiratory Medicine, The Third Xiangya Hospital, Central South University, Hunan, China[k]Department of Respiratory Medicine, Peking University People’s Hospital, Beijing, China l TaiGen Biotechnology Co., Ltd., Taipei, Taiwan
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. identifier: NCT01529476. Copyright (C) 2018, Taiwan Society of Microbiology. Published by Elsevier Taiwan LLC.
基金：
Major Research and Development Project of Innovative Drugs under the auspices of Ministry of Science and Technology of China [2008ZX09312-010, 2012ZX09303004-001]; TaiGen Biotechnology Co., Ltd.
第一作者机构：[a]Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China[b]China Key Laboratory of Clinical Pharmacology of Antibiotics, Ministry of Health, Shanghai, China
通讯作者：
通讯机构：[a]Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China[b]China Key Laboratory of Clinical Pharmacology of Antibiotics, Ministry of Health, Shanghai, China[*1]Institute of Antibiotics, Huashan Hospital, Fudan University, 12 Middle Wulumuqi Road, Shanghai 200040, China.
推荐引用方式(GB/T 7714)：
Jinyi Yuan,Biwen Mo,Zhuang Ma,et al.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[J].JOURNAL OF MICROBIOLOGY IMMUNOLOGY AND INFECTION.2019,52(1):35-44.doi:10.1016/j.jmii.2017.07.011.
APA：
Jinyi Yuan,Biwen Mo,Zhuang Ma,Yuan Lv,Shih-Lung Cheng...&Yingyuan Zhang.(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.JOURNAL OF MICROBIOLOGY IMMUNOLOGY AND INFECTION,52,(1)
MLA：
Jinyi Yuan,et al."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".JOURNAL OF MICROBIOLOGY IMMUNOLOGY AND INFECTION 52..1(2019):35-44
