A randomized, double-blind, multicenter Phase II study comparing the efficacy and safety of oral nemonoxacin with oral levofloxacin in the treatment of community-acquired pneumonia
机构：[1]Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China[2]China Key Laboratory of Clinical Pharmacology of Antibiotics, Ministry of Health, Shanghai, China[3]Department of Respiratory Medicine, The Third Xiangya Hospital, Central South University, Hunan, China[4]Department of Respiratory Medicine, Shengjing Hospital, China Medical University, Liaoning, China内科科室呼吸与重症监护内科中国医科大学盛京医院[5]Department of Respiratory Medicine, The First Affiliated Hospital, Zhejiang University, Zhejiang, China内科系统呼吸内科浙江大学医学院附属第一医院[6]Department of Respiratory Medicine, Gansu Provincial People’s Hospital, Lanzhou, China[7]Department of Respiratory Medicine, Hangzhou First People’s Hospital, Zhejiang, China[8]Department of Respiratory Medicine, Xinqiao Hospital, The Third Military Medical University, Chongqing, China[9]Department of Respiratory Medicine, Changzheng Hospital, The Second Military Medical University, Shanghai, China[10]Department of Respiratory Medicine, Jiangxi Provincial People’s Hospital, Jiangxi, China[11]Department of Respiratory Medicine, Peking University People’s Hospital, Beijing, China[12]Department of Respiratory Medicine, Daping Hospital, The Third Military Medical University, Chongqing, China[13]Department of Respiratory Medicine, Southwest Hospital, The Third Military Medical University, Chongqing, China[14]Department of Respiratory Medicine, East Hospital, Tongji University, Shanghai, China[15]Department of Respiratory Medicine, The General Hospital of Shenyang Military Command, Liaoning, China[16]Institute of Clinical Pharmacology, Peking University First Hospital, Beijing, China[17]Department of Respiratory Medicine, Xiangya Hospital, Central South University, Hunan, China[18]Center for Infectious Diseases, West China Hospital, Sichuan University, Chengdu, China[19]Department of Respiratory Medicine, Beijing Anzhen Hospital, Capital Medical University, Beijing, China临床科室呼吸内科首都医科大学附属安贞医院[20]Department of Respiratory Medicine, The Second Affiliated Hospital, Nanchang University, Jiangxi, China[21]Department of Respiratory Medicine, Sun Yat-sen Memorial Hospital, Sun Yat-Sen University, Guangdong, China[22]Department of Respiratory Medicine, Guangzhou Red Cross Hospital, Guangdong, China[23]TaiGen Biotechnology Co., Ltd., Taipei, Taiwan
Background/Purpose: To compare the clinical efficacy and safety of nemonoxacin with levofloxacin in treating community-acquired pneumonia (CAP) in a Phase II clinical trial. Methods: One hundred ninety-two patients with CAP were randomized to receive oral nemonoxacin (500 mg or 750 mg) or levofloxacin (500 mg) once daily for 7-10 days. Clinical and bacteriological responses were determined at the test of cure (TOC) visit in the full analysis set (FAS). Results: The clinical cure rate of nemonoxacin (500 mg), nemonoxacin (750 mg), and levofloxacin (500 mg) was 93.3%, 87.3%, and 88.5%, respectively, in the FAS (n = 168), and 93.0%, 93.9%, and 88.9%, respectively in the per protocol set (n = 152). At the TOC visit, nemonoxacin at 500 mg and 750 mg was proven to be noninferior to levofloxacin at 500 mg in the FAS in terms of clinical efficacy. The overall bacteriological success rate was 83.3% in both nemonoxacin groups and 80.0% in the levofloxacin 500 mg group in the bacteriological FAS. The comprehensive efficacy rate was comparable among the three groups (87.5% for the nemonoxacin 500 mg group, 93.8% for the nemonoxacin 750 mg group, and 81.3% for the levofloxacin 500 mg group). Most drug-related adverse events were mild and transient, mainly gastrointestinal symptoms such as nausea and vomiting, transient neutropenia, and elevated liver enzymes. No drug-related serious adverse events occurred. Conclusion: Either 500 mg or 750 mg of oral nemonoxacin taken once daily for 7-10 days demonstrated high clinical and bacteriological success rates in Chinese adult patients with CAP. Nemonoxacin at 500 mg once daily for 7e10 days is recommended for future Phase III clinical trials. Copyright (C) 2015, Taiwan Society of Microbiology. Published by Elsevier Taiwan LLC.
基金：
Major Research and Development Project of Innovative Drugs under the Ministry of Science and Technology in Beijing, China [2008ZX09312-010, 2012ZX09303004-001]
第一作者机构：[1]Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China[2]China Key Laboratory of Clinical Pharmacology of Antibiotics, Ministry of Health, Shanghai, China
通讯作者：
通讯机构：[1]Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China[2]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)：
Liu Yang,Zhang Yingyuan,Wu Jufang,et al.A randomized, double-blind, multicenter Phase II study comparing the efficacy and safety of oral nemonoxacin with oral levofloxacin in the treatment of community-acquired pneumonia[J].JOURNAL OF MICROBIOLOGY IMMUNOLOGY AND INFECTION.2017,50(6):811-820.doi:10.1016/j.jmii.2015.09.005.
APA：
Liu, Yang,Zhang, Yingyuan,Wu, Jufang,Zhu, Demei,Sun, Shenghua...&Chang, Liwen.(2017).A randomized, double-blind, multicenter Phase II study comparing the efficacy and safety of oral nemonoxacin with oral levofloxacin in the treatment of community-acquired pneumonia.JOURNAL OF MICROBIOLOGY IMMUNOLOGY AND INFECTION,50,(6)
MLA：
Liu, Yang,et al."A randomized, double-blind, multicenter Phase II study comparing the efficacy and safety of oral nemonoxacin with oral levofloxacin in the treatment of community-acquired pneumonia".JOURNAL OF MICROBIOLOGY IMMUNOLOGY AND INFECTION 50..6(2017):811-820
