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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
Authors: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
Affiliation:13. Department of Respiratory Medicine, Shengjing Hospital, China Medical University, Liaoning, China;14. Department of Respiratory Medicine, Putuo Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China;15. Department of Respiratory Medicine, The First Affiliated Hospital, Zhejiang University, Zhejiang, China;p. Department of Respiratory Medicine, Guangzhou Red Cross Hospital, Guangdong, China;q. Department of Respiratory Medicine, Huadong Hospital, Fudan University, Shanghai, China;r. Department of Respiratory Medicine, Central Hospital of Changsha, Hunan, China;s. Department of Respiratory Medicine, East Hospital, Tongji University, Shanghai, China;t. Department of Respiratory Medicine, Gansu Provincial People''s Hospital, Lanzhou, China;u. Department of Respiratory Medicine, Jiangxi Provincial People''s Hospital, Jiangxi, China;v. Center for Infectious Diseases, West China Hospital, Sichuan University, Chengdu, China;w. Department of Respiratory Medicine, The First Affiliated Hospital, Shanxi Medical University, Shanxi, China;x. Department of Respiratory Medicine, The Second Affiliated Hospital, Wenzhou Medical University, Zhejiang, China;y. Department of Respiratory Medicine, Hainan Provincial People''s Hospital, Hainan, China;z. Department of Respiratory Medicine, Wuhan General Hospital of Guangzhou Command, Wuhan, China;11. Department of Respiratory Medicine, People''s Hospital of Shenzhen, Guangdong, China;12. Department of Respiratory Medicine, Affiliated Hospital of Hainan Medical University, Hainan, China;13. Department of Respiratory Medicine, The Second Artillery General Hospital, Beijing, China;14. Department of Respiratory Medicine, Hunan Provincial People''s Hospital, Hunan, China;15. Department of Respiratory Medicine, Beijing Anzhen Hospital, Capital Medical University, Beijing, China;16. Department of Respiratory Medicine, Nanjing General Hospital, Nanjing, China;17. Department of Respiratory Medicine, Taihe Hospital, Hubei University of Medicine, Shiyan, Hubei, China;18. Department of Respiratory Medicine, The Second Affiliated Hospital, Nanchang University, Jiangxi, China;19. Department of Respiratory Medicine, Changzheng Hospital, Shanghai, China;110. Department of Respiratory Medicine, Daping Hospital, the Third Military Medical University, Chongqing, China;111. Department of Respiratory Medicine, The Second Affiliated Hospital, Zhongshan University, Guangdong, China;112. Department of Respiratory Medicine, The First Affiliated Hospital, Fujian medical University, Fujian, China;113. Department of Infectious Diseases, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China;114. Department of Respiratory Medicine, The Second Affiliated Hospital, Lanzhou University, Lanzhou, China;115. Department of Respiratory Medicine, The First Affiliated Hospital, Xinjiang Medical University, Xinjiang, China;1p. Department of Respiratory Medicine, Shanghai Jiao Tong University Affiliated Sixth People''s Hospital, Shanghai, China;1q. Department of Respiratory Medicine, Peking Union Medical College Hospital, Beijing, China;1r. Department of Respiratory Medicine, People''s Hospital of Wuhan University, Wuhan, China;1s. Department of Medical Research, Chi Mei Medical Center, Tainan, Taiwan;1t. Division of Pulmonary Medicine, Department of Internal Medicine, Tri-Service General Hospital, Taipei, Taiwan;1u. Division of Chest, Department of Internal Medicine, Chung Shan Medical University Hospital, Taichung, Taiwan;1v. Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan;1w. Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan;1x. Department of Internal Medicine, Division of Infectious Diseases, China Medical University Hospital, Taipei, Taiwan;1y. Cheng Hsin General Hospital, Taipei, Taiwan;1z. Department of Medicine, Section of Infectious Disease, E-Da Hospital, Kaohsiung City, Taiwan;21. Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan;22. Department of Internal Medicine, Ditmanson Medical Foundation Chia-Yi Christian Hospital, Chiayi, Taiwan;23. Department of Chest Medicine, Taipei Veterans General Hospital, Taipei, Taiwan;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, Affiliated Hospital of Guilin Medical University, Guangxi, China;4. Department of Respiratory Medicine, General Hospital of Shenyang Military Area Command, Liaoning, China;5. Institute of Clinical Pharmacology, Peking University First Hospital, Beijing, China;6. Department of Internal Medicine, Far Eastern Memorial Hospital, New Taipei City, Taiwan;7. Department of Respiratory Medicine, Central Hospital of Jinan, Jinan, China;8. Department of Respiratory Medicine, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China;9. Department of Chest Medicine, Cheng-Ching General Hospital, Taichung, Taiwan;10. Department of Respiratory Medicine, The Third Xiangya Hospital, Central South University, Hunan, China;11. Department of Respiratory Medicine, Peking University People''s Hospital, Beijing, China;12. TaiGen Biotechnology Co., Ltd., Taipei, Taiwan
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
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