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

Authors：Yuan Jinyi; Mo Biwen; Ma Zhuang; Lv Yuan; Cheng Shih Lung; Yang Yanping; Tong Zhaohui; Wu Renguang; Sun Shenghua; Cao Zhaolong; Wu Jufang; Zhu Demei; Chang Liwen; Zhang Yingyuan^*; Zhao Li; Wang Xiongbiao; Wang Xuefen; Wang Dexi; Li Xiangyang; Peng Yiqiang; Liang Yongjie; Liu Hua; Xiao Zuke; Lv Xiaoju; Wu Shiman; Dai Yuanrong; Huang Yijiang; Hu Zhenghong; Qiu Chen; Li Xi; Zhang Suiyang; Li Wenpu; Liu Shuang; Shi Yi; Xiong Chang; Kuang Jiulong; Xiu Qingyu; Cui Shehuai; Li Jianguo

Source：Journal of Microbiology, Immunology and Infection, 2019, 52(1): 35-44.

DOI：10.1016/j.jmii.2017.07.011

• Clinical outcome
• Community-acquired pneumonia
• Levofloxacin
• Nemonoxacin
• Randomized controlled trial
• Safety

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.

• Institution
  江西省人民医院; 温州医学院; 重庆医科大学; 上海交通大学; 中山大学; 中国人民解放军广州军区武汉总医院; 新疆医科大学; 海南省人民医院; 中国人民解放军南京军区南京总医院; 中国人民解放军第二炮兵总医院; 海南医学院; 天津市长征医院; 福建医科大学; 中国医学科学院北京协和医院; 武汉大学; 复旦大学; new; 山西医科大学; 湖南省人民医院; 湖北医药学院; 长沙市中心医院; 四川大学; 中南大学; 首都医科大学附属北京安贞医院; 南昌大学; 桂林医学院; 中国医科大学; 北京大学; 中国人民解放军沈阳军区总医院; 兰州大学; 上海中医药大学; 同济大学; 6; 浙江大学; 2; 中国人民解放军第三军医大学; 甘肃省人民医院; 济南市中心医院