• Ying Li, Demei Zhu, Yiqiang Peng, Zhaohui Tong, Zhuang Ma, Jinfu Xu, Shenghua Sun, Huaping Tang, Qingyu Xiu, Yongjie Liang, Xiongbiao Wang, Xiaoju Lv, Yuanrong Dai, Yingqun Zhu, Yuejin Qu, Kaifeng Xu, Yijiang Huang, Shiman Wu, Guoxiang Lai, Xi Li, Xiaowen Han, Zegang Yang, Jifang Sheng, Zhuola Liu, Hui Li, Yiqiang Chen, Huili Zhu, and Yingyuan Zhang.
• Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China.
• Curr Med Res Opin. 2021 Apr 1; 37 (4): 693-701.

ObjectivesTo evaluate the efficacy and safety of oral sitafloxacin versus oral moxifloxacin in the treatment of Chinese adults with community-acquired pneumonia (CAP).Patients And MethodsThis 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).ResultsA 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.ConclusionSitafloxacin 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.

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