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. Copyright (C) 2018, Taiwan Society of Microbiology. Published by Elsevier Taiwan LLC.
[1]Fudan Univ, Huashan Hosp, Inst Antibiot, 12 Middle Wulumuqi Rd, Shanghai 200040, Peoples R China;
[2]Minist Hlth, China Key Lab Clin Pharmacol Antibiot, Shanghai, Peoples R China;
[3]Guilin Med Univ, Dept Resp Med, Affiliated Hosp, Guangxi, Peoples R China;
[4]Gen Hosp Shenyang Mil Area Command, Dept Resp Med, Shenyang, Liaoning, Peoples R China;
[5]Peking Univ, Inst Clin Pharmacol, Hosp 1, Beijing, Peoples R China;
[6]Far Eastern Mem Hosp, Dept Internal Med, New Taipei, Taiwan;
[7]Cent Hosp Jinan, Dept Resp Med, Jinan, Shandong, Peoples R China;
[8]Capital Med Univ, Beijing Chao Yang Hosp, Dept Resp Med, Beijing, Peoples R China;
[9]Cheng Ching Gen Hosp, Dept Chest Med, Taichung, Taiwan;
[10]Cent S Univ, Xiangya Hosp 3, Dept Resp Med, Changsha, Hunan, Peoples R China;
[11]Peking Univ, Dept Resp Med, Peoples Hosp, Beijing, Peoples R China;
[12]TaiGen Biotechnol Co Ltd, Taipei, Taiwan;
[13]China Med Univ, Shengjing Hosp, Dept Resp Med, Shenyang, Liaoning, Peoples R China;
[14]Shanghai Univ Tradit Chinese Med, Putuo Hosp, Dept Resp Med, Shanghai, Peoples R China;
[15]Zhejiang Univ, Affiliated Hosp 1, Dept Resp Med, Zhejiang, Peoples R China;
[16]Guangzhou Red Cross Hosp, Dept Resp Med, Guangzhou, Guangdong, Peoples R China;
[17]Fudan Univ, Dept Resp Med, Huadong Hosp, Shanghai, Peoples R China;
[18]Cent Hosp Changsha, Dept Resp Med, Changsha, Hunan, Peoples R China;
[19]Tongji Univ, East Hosp, Dept Resp Med, Shanghai, Peoples R China;
[20]Gansu Prov Peoples Hosp, Dept Resp Med, Lanzhou, Gansu, Peoples R China;
[21]Jiangxi Prov Peoples Hosp, Dept Resp Med, Nanchang, Jiangxi, Peoples R China;
[22]Sichuan Univ, West China Hosp, Ctr Infect Dis, Chengdu, Sichuan, Peoples R China;
[23]Shanxi Med Univ, Affiliated Hosp 1, Dept Resp Med, Taiyuan, Shanxi, Peoples R China;
[24]Wenzhou Med Univ, Affiliated Hosp 2, Dept Resp Med, Wenzhou, Zhejiang, Peoples R China;
[25]Hainan Prov Peoples Hosp, Dept Resp Med, Haikou, Hainan, Peoples R China;
[26]Wuhan Gen Hosp Guangzhou Command, Dept Resp Med, Wuhan, Hubei, Peoples R China;
[27]Peoples Hosp Shenzhen, Dept Resp Med, Shenzhen, Guangdong, Peoples R China;
[28]Hainan Med Univ, Affiliated Hosp, Dept Resp Med, Haikou, Hainan, Peoples R China;
[29]Second Artillery Gen Hosp, Dept Resp Med, Beijing, Peoples R China;
[30]Hunan Prov Peoples Hosp, Dept Resp Med, Changsha, Hunan, Peoples R China;
[31]Capital Med Univ, Dept Resp Med, Beijing Anzhen Hosp, Beijing, Peoples R China;
[32]Nanjing Gen Hosp, Dept Resp Med, Nanjing, Jiangsu, Peoples R China;
[33]Hubei Univ Med, Taihe Hosp, Dept Resp Med, Shiyan, Hubei, Peoples R China;
[34]Nanchang Univ, Dept Resp Med, Affiliated Hosp 2, Nanchang, Jiangxi, Peoples R China;
[35]Changzheng Hosp, Dept Resp Med, Shanghai, Peoples R China;
[36]Third Mil Med Univ, Daping Hosp, Dept Resp Med, Chongqing, Peoples R China;
[37]Zhongshan Univ, Affiliated Hosp 2, Dept Resp Med, Zhongshan, Guangdong, Peoples R China;
[38]Fujian Med Univ, Affiliated Hosp 1, Dept Resp Med, Fuzhou, Fujian, Peoples R China;
[39]Chongqing Med Univ, Dept Infect Dis, Affiliated Hosp 1, Chongqing, Peoples R China;
[40]Lanzhou Univ, Affiliated Hosp 2, Dept Resp Med, Lanzhou, Gansu, Peoples R China;
[41]Xinjiang Med Univ, Affiliated Hosp 1, Dept Resp Med, Xinjiang, Peoples R China;
[42]Shanghai Jiao Tong Univ, Affiliated Peoples Hosp 6, Dept Resp Med, Shanghai, Peoples R China;
[43]Peking Union Med Coll Hosp, Dept Resp Med, Beijing, Peoples R China;
[44]Wuhan Univ, Peoples Hosp, Dept Resp Med, Wuhan, Hubei, Peoples R China;
[45]Chi Mei Med Ctr, Dept Med Res, Tainan, Taiwan;
[46]Triserv Gen Hosp, Dept Internal Med, Div Pulm Med, Taipei, Taiwan;
[47]Chung Shan Med Univ Hosp, Dept Internal Med, Div Chest, Taichung, Taiwan;
[48]Taichung Vet Gen Hosp, Dept Internal Med, Taichung, Taiwan;
[49]Kaohsiung Chang Gung Mem Hosp, Div Pulm & Crit Care Med, Dept Internal Med, Kaohsiung, Taiwan;
[50]China Med Univ Hosp, Dept Internal Med, Div Infect Dis, Taipei, Taiwan;
[51]Cheng Hsin Gen Hosp, Taipei, Taiwan;
[52]E Da Hosp, Sect Infect Dis, Dept Med, Kaohsiung, Taiwan;
[53]Natl Taiwan Univ Hosp, Dept Internal Med, Taipei, Taiwan;
[54]Ditmanson Med Fdn, Dept Internal Med, Chia Yi Christian Hosp, Chiayi, Taiwan;
[55]Taipei Vet Gen Hosp, Dept Chest Med, Taipei, Taiwan
(8.0+极速模式)