Ying Li1,2, Demei Zhu1, Yiqiang Peng3, Zhaohui Tong4, Zhuang Ma5, Jinfu Xu6, Shenghua Sun7, Huaping Tang8, Qingyu Xiu9, Yongjie Liang10, Xiongbiao Wang11, Xiaoju Lv12, Yuanrong Dai13, Yingqun Zhu14, Yuejin Qu15, Kaifeng Xu16, Yijiang Huang17, Shiman Wu18, Guoxiang Lai19, Xi Li20, Xiaowen Han21, Zegang Yang22, Jifang Sheng23, Zhuola Liu24, Hui Li25, Yiqiang Chen26, Huili Zhu27, Yingyuan Zhang1,2. 1. Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China. 2. Key Laboratory of Clinical Pharmacology of Antibiotics, National Health and Family Planning Commission, Shanghai, China. 3. Changsha Central Hospital, Changsha, China. 4. Beijing Chaoyang Hospital, Capital Medical University, Beijing, China. 5. General Hospital of Northern Theater Command of the People's Liberation Army (PLA), Shenyang, China. 6. Shanghai Pulmonary Hospital, Shanghai, China. 7. The Third Xiangya Hospital of Central South University, Changsha, China. 8. Qingdao Municipal Hospital, Qingdao, China. 9. Shanghai Changzheng Hospital, Shanghai, China. 10. Shanghai East Hospital, Shanghai, China. 11. Putuo District Central Hospital, Shanghai, China. 12. West China Hospital, Sichuan University, Chengdu, China. 13. The Second Affiliated Hospital of Wenzhou Medical University, Wenzhou, China. 14. The Third Hospital of Changsha, Changsha, China. 15. The First Affiliated Hospital of Xiamen University, Xiamen, China. 16. Peking Union Medical College Hospital, Beijing, China. 17. Hainan Provincial People's Hospital, Haikou, China. 18. The First Hospital of Shanxi Medical University, Taiyuan, China. 19. No. 900 Hospital, Joint Logistics Support Force of PLA, Fuzhou, China. 20. The First Affiliated Hospital of Hainan Medical College, Haikou, China. 21. Hebei Provincial People's Hospital, Shijiazhuang, China. 22. Changde First People's Hospital, Changde, China. 23. The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China. 24. The Second Hospital of Shanxi Medical University, Taiyuan, China. 25. Jilin Provincial People's Hospital, Changchun, China. 26. The First Affiliated Hospital of Guangxi Medical University, Nanning, China. 27. Huadong Hospital Affiliated to Fudan University, Shanghai, China.
Abstract
OBJECTIVES: To evaluate the efficacy and safety of oral sitafloxacin versus oral moxifloxacin in the treatment of Chinese adults with community-acquired pneumonia (CAP). PATIENTS AND METHODS: This is a multicenter, randomized, open-label, positive-controlled clinical trial (chinadrugtrials.org.cn identifier: CTR20130046). CAP patients received sitafloxacin tablets 100 mg once daily (qd) or 100 mg twice daily (bid) to compare with moxifloxacin tablets 400 mg qd, for 7-10 days. The primary outcome was non-inferiority of sitafloxacin to moxifloxacin in clinical cure rate at test of cure (TOC) visit in per-protocol set (PPS). RESULTS: A total of 343 patients wererandomized (sitafloxacin 100 mg qd, n = 117; sitafloxacin 100 mg bid, n = 116; moxifloxacin, n = 110), 291 patients were included in the PPS (sitafloxacin 100 mg qd, n = 96; sitafloxacin 100 mg bid, n = 94; moxifloxacin, n = 101). The clinical cure rate was 94.8% in the sitafloxacin 100 mg qd group, 96.8% in the sitafloxacin 100 mg bid group and 95.0% in the moxifloxacin group. At the TOC visit, the microbiological success rate was 97.0% (32/33) in the sitafloxacin 100 mg qd group, 97.1% (34/35) in the sitafloxacin 100 mg bid group and 94.9% (37/39) in the moxifloxacin group in the microbiological evaluable set (MES). The incidence of study-drug-related adverse events (AEs) was 23.3% (27/116) in the sitafloxacin 100 mg qd group, 29.8% (34/114) in the sitafloxacin 100 mg bid group and 28.2% (31/110) in the moxifloxacin group (p > .05). The common AEs related to study drug were dizziness, nausea, diarrhea, increased platelet count and alanine transaminase (ALT) elevation. All the AEs resolved completely after discontinuation of study drug. CONCLUSION:Sitafloxacin 100 mg qd or 100 mg bid for 7-10 days is not inferior to moxifloxacin 400 mg qd for 7-10 days in clinical efficacy for adult CAP patients. Sitafloxacin provides a safety profile comparable to moxifloxacin.
RCT Entities:
OBJECTIVES: To evaluate the efficacy and safety of oral sitafloxacin versus oral moxifloxacin in the treatment of Chinese adults with community-acquired pneumonia (CAP). PATIENTS AND METHODS: This is a multicenter, randomized, open-label, positive-controlled clinical trial (chinadrugtrials.org.cn identifier: CTR20130046). CAP patients received sitafloxacin tablets 100 mg once daily (qd) or 100 mg twice daily (bid) to compare with moxifloxacin tablets 400 mg qd, for 7-10 days. The primary outcome was non-inferiority of sitafloxacin to moxifloxacin in clinical cure rate at test of cure (TOC) visit in per-protocol set (PPS). RESULTS: A total of 343 patients were randomized (sitafloxacin 100 mg qd, n = 117; sitafloxacin 100 mg bid, n = 116; moxifloxacin, n = 110), 291 patients were included in the PPS (sitafloxacin 100 mg qd, n = 96; sitafloxacin 100 mg bid, n = 94; moxifloxacin, n = 101). The clinical cure rate was 94.8% in the sitafloxacin 100 mg qd group, 96.8% in the sitafloxacin 100 mg bid group and 95.0% in the moxifloxacin group. At the TOC visit, the microbiological success rate was 97.0% (32/33) in the sitafloxacin 100 mg qd group, 97.1% (34/35) in the sitafloxacin 100 mg bid group and 94.9% (37/39) in the moxifloxacin group in the microbiological evaluable set (MES). The incidence of study-drug-related adverse events (AEs) was 23.3% (27/116) in the sitafloxacin 100 mg qd group, 29.8% (34/114) in the sitafloxacin 100 mg bid group and 28.2% (31/110) in the moxifloxacin group (p > .05). The common AEs related to study drug were dizziness, nausea, diarrhea, increased platelet count and alanine transaminase (ALT) elevation. All the AEs resolved completely after discontinuation of study drug. CONCLUSION:Sitafloxacin 100 mg qd or 100 mg bid for 7-10 days is not inferior to moxifloxacin 400 mg qd for 7-10 days in clinical efficacy for adult CAP patients. Sitafloxacin provides a safety profile comparable to moxifloxacin.