Yang Liu1, Yingyuan Zhang2, Jufang Wu1, Demei Zhu1, Shenghua Sun3, Li Zhao4, Xuefeng Wang5, Hua Liu6, Zhenyi Ren7, Changzheng Wang8, Qingyu Xiu9, Zuke Xiao10, Zhaolong Cao11, Shehuai Cui12, Heping Yang13, Yongjie Liang14, Ping Chen15, Yuan Lv16, Chengping Hu17, Xiaoju Lv18, Shuang Liu19, Jiulong Kuang20, Jianguo Li21, Dexi Wang22, Liwen Chang23. 1. Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China; China Key Laboratory of Clinical Pharmacology of Antibiotics, Ministry of Health, Shanghai, China. 2. 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. 3. Department of Respiratory Medicine, The Third Xiangya Hospital, Central South University, Hunan, China. 4. Department of Respiratory Medicine, Shengjing Hospital, China Medical University, Liaoning, China. 5. Department of Respiratory Medicine, The First Affiliated Hospital, Zhejiang University, Zhejiang, China. 6. Department of Respiratory Medicine, Gansu Provincial People's Hospital, Lanzhou, China. 7. Department of Respiratory Medicine, Hangzhou First People's Hospital, Zhejiang, China. 8. Department of Respiratory Medicine, Xinqiao Hospital, The Third Military Medical University, Chongqing, China. 9. Department of Respiratory Medicine, Changzheng Hospital, The Second Military Medical University, Shanghai, China. 10. Department of Respiratory Medicine, Jiangxi Provincial People's Hospital, Jiangxi, China. 11. Department of Respiratory Medicine, Peking University People's Hospital, Beijing, China. 12. Department of Respiratory Medicine, Daping Hospital, The Third Military Medical University, Chongqing, China. 13. Department of Respiratory Medicine, Southwest Hospital, The Third Military Medical University, Chongqing, China. 14. Department of Respiratory Medicine, East Hospital, Tongji University, Shanghai, China. 15. Department of Respiratory Medicine, The General Hospital of Shenyang Military Command, Liaoning, China. 16. Institute of Clinical Pharmacology, Peking University First Hospital, Beijing, China. 17. Department of Respiratory Medicine, Xiangya Hospital, Central South University, Hunan, China. 18. Center for Infectious Diseases, West China Hospital, Sichuan University, Chengdu, China. 19. Department of Respiratory Medicine, Beijing Anzhen Hospital, Capital Medical University, Beijing, China. 20. Department of Respiratory Medicine, The Second Affiliated Hospital, Nanchang University, Jiangxi, China. 21. Department of Respiratory Medicine, Sun Yat-sen Memorial Hospital, Sun Yat-Sen University, Guangdong, China. 22. Department of Respiratory Medicine, Guangzhou Red Cross Hospital, Guangdong, China. 23. TaiGen Biotechnology Co., Ltd., Taipei, Taiwan.
Abstract
BACKGROUND/ PURPOSE: To compare the clinical efficacy and safety of nemonoxacin with levofloxacin in treating community-acquired pneumonia (CAP) in a Phase II clinical trial. METHODS:One 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). RESULTS: The 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. CONCLUSION: Either 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.
RCT Entities:
BACKGROUND/ PURPOSE: To compare the clinical efficacy and safety of nemonoxacin with levofloxacin in treating community-acquired pneumonia (CAP) in a Phase II clinical trial. METHODS: One 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). RESULTS: The 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. CONCLUSION: Either 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.
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