• Yang Liu, Yingyuan Zhang, Jufang Wu, Demei Zhu, Shenghua Sun, Li Zhao, Xuefeng Wang, Hua Liu, Zhenyi Ren, Changzheng Wang, Qingyu Xiu, Zuke Xiao, Zhaolong Cao, Shehuai Cui, Heping Yang, Yongjie Liang, Ping Chen, Yuan Lv, Chengping Hu, Xiaoju Lv, Shuang Liu, Jiulong Kuang, Jianguo Li, Dexi Wang, and Liwen Chang.
• Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China; China Key Laboratory of Clinical Pharmacology of Antibiotics, Ministry of Health, Shanghai, China.
• J Microbiol Immunol Infect. 2017 Dec 1; 50 (6): 811-820.

Background/PurposeTo compare the clinical efficacy and safety of nemonoxacin with levofloxacin in treating community-acquired pneumonia (CAP) in a Phase II clinical trial.MethodsOne 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).ResultsThe 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.ConclusionEither 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.Copyright © 2015. Published by Elsevier B.V.

34 keywords...

hide…