Jinyi Yuan1, Biwen Mo2, Zhuang Ma3, Yuan Lv4, Shih-Lung Cheng5, Yanping Yang6, Zhaohui Tong7, Renguang Wu8, Shenghua Sun9, Zhaolong Cao10, Jufang Wu1, Demei Zhu1, Liwen Chang11, Yingyuan Zhang12. 1. Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China; China Key Laboratory of Clinical Pharmacology of Antibiotics, Ministry of Health, Shanghai, China. 2. Department of Respiratory Medicine, Affiliated Hospital of Guilin Medical University, Guangxi, China. 3. Department of Respiratory Medicine, General Hospital of Shenyang Military Area Command, Liaoning, China. 4. Institute of Clinical Pharmacology, Peking University First Hospital, Beijing, China. 5. Department of Internal Medicine, Far Eastern Memorial Hospital, New Taipei City, Taiwan. 6. Department of Respiratory Medicine, Central Hospital of Jinan, Jinan, China. 7. Department of Respiratory Medicine, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China. 8. Department of Chest Medicine, Cheng-Ching General Hospital, Taichung, Taiwan. 9. Department of Respiratory Medicine, The Third Xiangya Hospital, Central South University, Hunan, China. 10. Department of Respiratory Medicine, Peking University People's Hospital, Beijing, China. 11. TaiGen Biotechnology Co., Ltd., Taipei, Taiwan. 12. 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.
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 receivingnemonoxacin 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.
RCT Entities:
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.
Authors: Despoina Koulenti; Elena Xu; Andrew Song; Isaac Yin Sum Mok; Drosos E Karageorgopoulos; Apostolos Armaganidis; Sotirios Tsiodras; Jeffrey Lipman Journal: Microorganisms Date: 2020-01-30