A randomized, controlled, multicenter clinical trial to evaluate the efficacy and safety of oral sitafloxacin versus moxifloxacin in adult patients with community-acquired pneumonia Article Swipe
YOU?
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· 2021
· Open Access
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· DOI: https://doi.org/10.6084/m9.figshare.13708364.v1
To evaluate the efficacy and safety of oral sitafloxacin versus oral moxifloxacin in the treatment of Chinese adults with community-acquired pneumonia (CAP). This is a multicenter, randomized, open-label, positive-controlled clinical trial (chinadrugtrials.org.cn identifier: CTR20130046). CAP patients received sitafloxacin tablets 100mg once daily (qd) or 100mg twice daily (bid) to compare with moxifloxacin tablets 400mg 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). A total of 343 patients were randomized (sitafloxacin 100mg qd, n = 117, sitafloxacin 100mg bid, n = 116, moxifloxacin, n = 110), 291 patients were included in PPS (sitafloxacin 100mg qd, n = 96, sitafloxacin 100mg bid, n = 94, moxifloxacin, n = 101). The clinical cure rate was 94.8% in sitafloxacin 100mg qd group, 96.8% in sitafloxacin 100mg bid group, and 95.0% in moxifloxacin group. At TOC visit, the microbiological success rate was 97.0% (32/33) in sitafloxacin 100mg qd group, 97.1% (34/35) in sitafloxacin 100mg bid group, and 94.9% (37/39) in moxifloxacin group in microbiological evaluable set (MES). The incidence of study drug-related adverse events (AEs) was 23.3% (27/116) in sitafloxacin 100mg qd group, 29.8% (34/114) in sitafloxacin 100mg bid group, and 28.2% (31/110) in moxifloxacin group (P > 0.05). The common AEs related to study drug were dizziness, nausea, diarrhea, increased platelet count, and ALT elevation. All the AEs resolved completely after discontinuation of study drug. Sitafloxacin 100mg qd or 100mg bid for 7-10 days is not inferior to moxifloxacin 400mg qd for 7-10 days in the clinical efficacy for adult CAP patients. Sitafloxacin provides safety profile comparable to moxifloxacin.
Related Topics
- Type
- dataset
- Language
- en
- Landing Page
- https://doi.org/10.6084/m9.figshare.13708364.v1
- OA Status
- gold
- Related Works
- 10
- OpenAlex ID
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Raw OpenAlex JSON
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https://openalex.org/W4394553987Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.6084/m9.figshare.13708364.v1Digital Object Identifier
- Title
-
A randomized, controlled, multicenter clinical trial to evaluate the efficacy and safety of oral sitafloxacin versus moxifloxacin in adult patients with community-acquired pneumoniaWork title
- Type
-
datasetOpenAlex work type
- Language
-
enPrimary language
- Publication year
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2021Year of publication
- Publication date
-
2021-01-01Full publication date if available
- Authors
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Ying Li, Demei Zhu, Yiqiang Peng, Zhaohui Tong, Zhuang Ma, XU Jin-fu, 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, Zhuo-la Liu, Hui Li, Yiqiang Chen, Huili Zhu, Yingyuan ZhangList of authors in order
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https://doi.org/10.6084/m9.figshare.13708364.v1Publisher landing page
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YesWhether a free full text is available
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goldOpen access status per OpenAlex
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https://doi.org/10.6084/m9.figshare.13708364.v1Direct OA link when available
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Moxifloxacin, Medicine, Pneumonia, Clinical trial, Randomized controlled trial, Internal medicine, Multicenter study, Community-acquired pneumonia, Antibiotics, Biology, MicrobiologyTop concepts (fields/topics) attached by OpenAlex
- Cited by
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0Total citation count in OpenAlex
- Related works (count)
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10Other works algorithmically related by OpenAlex
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| abstract_inverted_index.343 | 84 |
| abstract_inverted_index.94, | 121 |
| abstract_inverted_index.96, | 115 |
| abstract_inverted_index.AEs | 215, 232 |
| abstract_inverted_index.ALT | 228 |
| abstract_inverted_index.All | 230 |
| abstract_inverted_index.CAP | 34, 265 |
| abstract_inverted_index.PPS | 109 |
| abstract_inverted_index.TOC | 149 |
| abstract_inverted_index.The | 58, 126, 181, 213 |
| abstract_inverted_index.and | 4, 143, 170, 204, 227 |
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| abstract_inverted_index.110), | 103 |
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| abstract_inverted_index.(MES). | 180 |
| abstract_inverted_index.(PPS). | 80 |
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| abstract_inverted_index.(31/110) | 206 |
| abstract_inverted_index.(34/114) | 198 |
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