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
Jinyi Yuan, Biwen Mo, Zhuang Ma, Yuan Lv, Shih-Lung Cheng, Yanping Yang, Zhaohui Tong, Renguang Wu, Shenghua Sun, Zhaolong Cao, Jufang Wu, Demei Zhu, Liwen Chang, Yingyuan Zhang, Investigator Group of the Phase 3 Study on Oral Nemonoxacin, Li Zhao, Xiongbiao Wang, Xuefen Wang, Dexi Wang, Xiangyang Li, Yiqiang Peng, Yongjie Liang, Hua Liu, Zuke Xiao, Xiaoju Lv, Shiman Wu, Yuanrong Dai, Yijiang Huang, Zhenghong Hu, Chen Qiu, Xi Li, Suiyang Zhang, Wenpu Li, Shuang Liu, Yi Shi, Chang Xiong, Jiulong Kuang, Qingyu Xiu, Shehuai Cui, Jianguo Li, Qichang Lin, Wenxiang Huang, Yixin Wan, Qimanguli, Ce Shen, Yi Xiao, Xiaoju Wu, Yin Ching Chuang, Wann Cherng Perng, Shih-Ming Tsao, Jeng-Yuan Hsu, Chin-Chou Wang, Jen-Hsien Wang, Pen-Fang Yeh, His-Hsun Lin, P H Kuo, Ming-Shian Lin, Wei-Juin Su, Jinyi Yuan, Biwen Mo, Zhuang Ma, Yuan Lv, Shih-Lung Cheng, Yanping Yang, Zhaohui Tong, Renguang Wu, Shenghua Sun, Zhaolong Cao, Jufang Wu, Demei Zhu, Liwen Chang, Yingyuan Zhang, Investigator Group of the Phase 3 Study on Oral Nemonoxacin, Li Zhao, Xiongbiao Wang, Xuefen Wang, Dexi Wang, Xiangyang Li, Yiqiang Peng, Yongjie Liang, Hua Liu, Zuke Xiao, Xiaoju Lv, Shiman Wu, Yuanrong Dai, Yijiang Huang, Zhenghong Hu, Chen Qiu, Xi Li, Suiyang Zhang, Wenpu Li, Shuang Liu, Yi Shi, Chang Xiong, Jiulong Kuang, Qingyu Xiu, Shehuai Cui, Jianguo Li, Qichang Lin, Wenxiang Huang, Yixin Wan, Qimanguli, Ce Shen, Yi Xiao, Xiaoju Wu, Yin Ching Chuang, Wann Cherng Perng, Shih-Ming Tsao, Jeng-Yuan Hsu, Chin-Chou Wang, Jen-Hsien Wang, Pen-Fang Yeh, His-Hsun Lin, P H Kuo, Ming-Shian Lin, Wei-Juin Su
Abstract
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. ClinicalTrials.gov identifier: NCT01529476.
Keywords: Clinical outcome; Community-acquired pneumonia; Levofloxacin; Nemonoxacin; Randomized controlled trial; Safety.
Copyright © 2018. Published by Elsevier B.V.
Source: PubMed