title: 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.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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 7-10 days is recommended for future Phase III clinical trials. ClinicalTrials.gov identifier: NCT01537250.
authors.affiliation: Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China; China Key Laboratory of Clinical Pharmacology of Antibiotics, Ministry of Health, Shanghai, China.
authors.forename: Yang
authors.initials: Y
authors.lastname: Liu
authors.affiliation: Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China; China Key Laboratory of Clinical Pharmacology of Antibiotics, Ministry of Health, Shanghai, China. Electronic address: yyzhang39@hotmail.com.
authors.forename: Yingyuan
authors.initials: Y
authors.lastname: Zhang
authors.affiliation: Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China; China Key Laboratory of Clinical Pharmacology of Antibiotics, Ministry of Health, Shanghai, China.
authors.forename: Jufang
authors.initials: J
authors.lastname: Wu
authors.affiliation: Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China; China Key Laboratory of Clinical Pharmacology of Antibiotics, Ministry of Health, Shanghai, China.
authors.forename: Demei
authors.initials: D
authors.lastname: Zhu
authors.affiliation: Department of Respiratory Medicine, The Third Xiangya Hospital, Central South University, Hunan, China.
authors.forename: Shenghua
authors.initials: S
authors.lastname: Sun
authors.affiliation: Department of Respiratory Medicine, Shengjing Hospital, China Medical University, Liaoning, China.
authors.forename: Li
authors.initials: L
authors.lastname: Zhao
authors.affiliation: Department of Respiratory Medicine, The First Affiliated Hospital, Zhejiang University, Zhejiang, China.
authors.forename: Xuefeng
authors.initials: X
authors.lastname: Wang
authors.affiliation: Department of Respiratory Medicine, Gansu Provincial People's Hospital, Lanzhou, China.
authors.forename: Hua
authors.initials: H
authors.lastname: Liu
authors.affiliation: Department of Respiratory Medicine, Hangzhou First People's Hospital, Zhejiang, China.
authors.forename: Zhenyi
authors.initials: Z
authors.lastname: Ren
authors.affiliation: Department of Respiratory Medicine, Xinqiao Hospital, The Third Military Medical University, Chongqing, China.
authors.forename: Changzheng
authors.initials: C
authors.lastname: Wang
authors.affiliation: Department of Respiratory Medicine, Changzheng Hospital, The Second Military Medical University, Shanghai, China.
authors.forename: Qingyu
authors.initials: Q
authors.lastname: Xiu
authors.affiliation: Department of Respiratory Medicine, Jiangxi Provincial People's Hospital, Jiangxi, China.
authors.forename: Zuke
authors.initials: Z
authors.lastname: Xiao
authors.affiliation: Department of Respiratory Medicine, Peking University People's Hospital, Beijing, China.
authors.forename: Zhaolong
authors.initials: Z
authors.lastname: Cao
authors.affiliation: Department of Respiratory Medicine, Daping Hospital, The Third Military Medical University, Chongqing, China.
authors.forename: Shehuai
authors.initials: S
authors.lastname: Cui
authors.affiliation: Department of Respiratory Medicine, Southwest Hospital, The Third Military Medical University, Chongqing, China.
authors.forename: Heping
authors.initials: H
authors.lastname: Yang
authors.affiliation: Department of Respiratory Medicine, East Hospital, Tongji University, Shanghai, China.
authors.forename: Yongjie
authors.initials: Y
authors.lastname: Liang
authors.affiliation: Department of Respiratory Medicine, The General Hospital of Shenyang Military Command, Liaoning, China.
authors.forename: Ping
authors.initials: P
authors.lastname: Chen
authors.affiliation: Institute of Clinical Pharmacology, Peking University First Hospital, Beijing, China.
authors.forename: Yuan
authors.initials: Y
authors.lastname: Lv
authors.affiliation: Department of Respiratory Medicine, Xiangya Hospital, Central South University, Hunan, China.
authors.forename: Chengping
authors.initials: C
authors.lastname: Hu
authors.affiliation: Center for Infectious Diseases, West China Hospital, Sichuan University, Chengdu, China.
authors.forename: Xiaoju
authors.initials: X
authors.lastname: Lv
authors.affiliation: Department of Respiratory Medicine, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.
authors.forename: Shuang
authors.initials: S
authors.lastname: Liu
authors.affiliation: Department of Respiratory Medicine, The Second Affiliated Hospital, Nanchang University, Jiangxi, China.
authors.forename: Jiulong
authors.initials: J
authors.lastname: Kuang
authors.affiliation: Department of Respiratory Medicine, Sun Yat-sen Memorial Hospital, Sun Yat-Sen University, Guangdong, China.
authors.forename: Jianguo
authors.initials: J
authors.lastname: Li
authors.affiliation: Department of Respiratory Medicine, Guangzhou Red Cross Hospital, Guangdong, China.
authors.forename: Dexi
authors.initials: D
authors.lastname: Wang
authors.affiliation: TaiGen Biotechnology Co., Ltd., Taipei, Taiwan.
authors.forename: Liwen
authors.initials: L
authors.lastname: Chang
mesh_terms: D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D017714:Community-Acquired Infections / Q000188:drug therapy; D004311:Double-Blind Method; D005260:Female; D006193:Haemophilus influenzae / Q000187:drug effects; D006801:Humans; D064704:Levofloxacin / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009177:Mycoplasma pneumoniae / Q000187:drug effects; D018410:Pneumonia, Bacterial / Q000188:drug therapy* / Q000382:microbiology; D015363:Quinolones / Q000009:adverse effects / Q000627:therapeutic use*; D013296:Streptococcus pneumoniae / Q000187:drug effects; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D015363:Quinolones; D064704:Levofloxacin; C543520:nemonoxacin
keywords: clinical trial; community-acquired pneumonia; efficacy; nenomoxacin; safety