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
Ying Li
,
Demei Zhu
,
Yiqiang Peng
,
Zhaohui Tong
,
Zhuang Ma
,
Jin‐Fu 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
,
Zhuo-la Liu
,
Hui Li
,
Yiqiang Chen
,
Huili Zhu
,
Yingyuan Zhang
·
YOU?
·
· 2021
· Open Access
·
· DOI: https://doi.org/10.6084/m9.figshare.13708364
YOU?
·
· 2021
· Open Access
·
· DOI: https://doi.org/10.6084/m9.figshare.13708364
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 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). 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. 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.
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Concepts
Metadata
- Type
- dataset
- Language
- en
- Landing Page
- https://doi.org/10.6084/m9.figshare.13708364
- OA Status
- gold
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4394428015
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4394428015Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.6084/m9.figshare.13708364Digital 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
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enPrimary language
- Publication year
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2021Year of publication
- Publication date
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2021-01-01Full publication date if available
- Authors
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Ying Li, Demei Zhu, Yiqiang Peng, Zhaohui Tong, Zhuang Ma, Jin‐Fu 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, 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.13708364Publisher landing page
- Open access
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YesWhether a free full text is available
- OA status
-
goldOpen access status per OpenAlex
- OA URL
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https://doi.org/10.6084/m9.figshare.13708364Direct OA link when available
- Concepts
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Moxifloxacin, Medicine, Pneumonia, Community-acquired pneumonia, Randomized controlled trial, Clinical trial, Internal medicine, Intensive care medicine, Antibiotics, Microbiology, BiologyTop concepts (fields/topics) attached by OpenAlex
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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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| best_oa_location.is_accepted | False |
| best_oa_location.is_published | False |
| best_oa_location.raw_source_name | |
| best_oa_location.landing_page_url | https://doi.org/10.6084/m9.figshare.13708364 |
| primary_location.id | doi:10.6084/m9.figshare.13708364 |
| primary_location.is_oa | True |
| primary_location.source | |
| primary_location.license | cc-by |
| primary_location.pdf_url | |
| primary_location.version | |
| primary_location.raw_type | dataset |
| primary_location.license_id | https://openalex.org/licenses/cc-by |
| primary_location.is_accepted | False |
| primary_location.is_published | False |
| primary_location.raw_source_name | |
| primary_location.landing_page_url | https://doi.org/10.6084/m9.figshare.13708364 |
| publication_date | 2021-01-01 |
| publication_year | 2021 |
| referenced_works_count | 0 |
| abstract_inverted_index.= | 96, 103, 107, 121, 128, 132 |
| abstract_inverted_index.A | 84 |
| abstract_inverted_index.a | 24, 297 |
| abstract_inverted_index.At | 161 |
| abstract_inverted_index.To | 0 |
| abstract_inverted_index.at | 74 |
| abstract_inverted_index.in | 12, 70, 80, 113, 140, 148, 157, 172, 181, 191, 195, 211, 220, 230, 288 |
| abstract_inverted_index.is | 23, 277 |
| abstract_inverted_index.mg | 40, 46, 56, 93, 100, 118, 125, 144, 152, 176, 185, 215, 224, 268, 272, 283 |
| abstract_inverted_index.of | 6, 15, 66, 76, 86, 203, 263 |
| abstract_inverted_index.or | 44, 270 |
| abstract_inverted_index.qd | 145, 177, 216, 269, 284 |
| abstract_inverted_index.to | 50, 68, 241, 280, 301 |
| abstract_inverted_index.100 | 39, 45, 92, 99, 117, 124, 143, 151, 175, 184, 214, 223, 267, 271 |
| abstract_inverted_index.291 | 109 |
| abstract_inverted_index.343 | 87 |
| abstract_inverted_index.400 | 55, 282 |
| abstract_inverted_index.94; | 129 |
| abstract_inverted_index.96; | 122 |
| abstract_inverted_index.AEs | 239, 258 |
| abstract_inverted_index.All | 256 |
| abstract_inverted_index.CAP | 34, 293 |
| abstract_inverted_index.PPS | 115 |
| abstract_inverted_index.TOC | 163 |
| abstract_inverted_index.The | 61, 134, 201, 237 |
| abstract_inverted_index.and | 4, 155, 188, 227, 251 |
| abstract_inverted_index.bid | 153, 186, 225, 273 |
| abstract_inverted_index.for | 58, 274, 285, 291 |
| abstract_inverted_index.not | 278 |
| abstract_inverted_index.qd, | 57, 94, 119 |
| abstract_inverted_index.set | 82, 199 |
| abstract_inverted_index.the | 2, 13, 114, 141, 149, 158, 162, 165, 173, 182, 192, 196, 212, 221, 231, 257 |
| abstract_inverted_index.was | 64, 138, 169, 208 |
| abstract_inverted_index.> | 235 |
| abstract_inverted_index.(qd) | 43 |
| abstract_inverted_index.116; | 104 |
| abstract_inverted_index.117; | 97 |
| abstract_inverted_index.This | 22 |
| abstract_inverted_index.bid, | 101, 126 |
| abstract_inverted_index.cure | 72, 77, 136 |
| abstract_inverted_index.days | 276, 287 |
| abstract_inverted_index.drug | 243 |
| abstract_inverted_index.once | 41 |
| abstract_inverted_index.oral | 7, 10 |
| abstract_inverted_index.rate | 73, 137, 168 |
| abstract_inverted_index.test | 75 |
| abstract_inverted_index.were | 89, 111, 244 |
| abstract_inverted_index.with | 18, 52 |
| abstract_inverted_index.(AEs) | 207 |
| abstract_inverted_index.(ALT) | 254 |
| abstract_inverted_index.(TOC) | 78 |
| abstract_inverted_index.(bid) | 49 |
| abstract_inverted_index..05). | 236 |
| abstract_inverted_index.101). | 133 |
| abstract_inverted_index.110), | 108 |
| abstract_inverted_index.23.3% | 209 |
| abstract_inverted_index.28.2% | 228 |
| abstract_inverted_index.29.8% | 218 |
| abstract_inverted_index.94.8% | 139 |
| abstract_inverted_index.94.9% | 189 |
| abstract_inverted_index.95.0% | 156 |
| abstract_inverted_index.96.8% | 147 |
| abstract_inverted_index.97.0% | 170 |
| abstract_inverted_index.97.1% | 179 |
| abstract_inverted_index.adult | 292 |
| abstract_inverted_index.after | 261 |
| abstract_inverted_index.count | 250 |
| abstract_inverted_index.daily | 42, 48 |
| abstract_inverted_index.days. | 60 |
| abstract_inverted_index.drug. | 265 |
| abstract_inverted_index.group | 154, 187, 194, 226, 233 |
| abstract_inverted_index.study | 242, 264 |
| abstract_inverted_index.total | 85 |
| abstract_inverted_index.trial | 30 |
| abstract_inverted_index.twice | 47 |
| abstract_inverted_index.visit | 79 |
| abstract_inverted_index.(CAP). | 21 |
| abstract_inverted_index.(MES). | 200 |
| abstract_inverted_index.(PPS). | 83 |
| abstract_inverted_index.7–10 | 59, 275, 286 |
| abstract_inverted_index.adults | 17 |
| abstract_inverted_index.common | 238 |
| abstract_inverted_index.events | 206 |
| abstract_inverted_index.group, | 146, 178, 217 |
| abstract_inverted_index.group. | 160 |
| abstract_inverted_index.safety | 5, 298 |
| abstract_inverted_index.versus | 9 |
| abstract_inverted_index.visit, | 164 |
| abstract_inverted_index.(32/33) | 171 |
| abstract_inverted_index.(34/35) | 180 |
| abstract_inverted_index.(37/39) | 190 |
| abstract_inverted_index.Chinese | 16 |
| abstract_inverted_index.adverse | 205 |
| abstract_inverted_index.alanine | 252 |
| abstract_inverted_index.compare | 51 |
| abstract_inverted_index.nausea, | 246 |
| abstract_inverted_index.outcome | 63 |
| abstract_inverted_index.primary | 62 |
| abstract_inverted_index.profile | 299 |
| abstract_inverted_index.related | 240 |
| abstract_inverted_index.success | 167 |
| abstract_inverted_index.tablets | 38, 54 |
| abstract_inverted_index.(27/116) | 210 |
| abstract_inverted_index.(31/110) | 229 |
| abstract_inverted_index.(34/114) | 219 |
| abstract_inverted_index.<i>n</i> | 95, 102, 106, 120, 127, 131 |
| abstract_inverted_index.clinical | 29, 71, 135, 289 |
| abstract_inverted_index.efficacy | 3, 290 |
| abstract_inverted_index.evaluate | 1 |
| abstract_inverted_index.included | 112 |
| abstract_inverted_index.inferior | 279 |
| abstract_inverted_index.patients | 35, 88, 110 |
| abstract_inverted_index.platelet | 249 |
| abstract_inverted_index.provides | 296 |
| abstract_inverted_index.received | 36 |
| abstract_inverted_index.resolved | 259 |
| abstract_inverted_index.(<i>p</i> | 234 |
| abstract_inverted_index.diarrhea, | 247 |
| abstract_inverted_index.evaluable | 198 |
| abstract_inverted_index.incidence | 202 |
| abstract_inverted_index.increased | 248 |
| abstract_inverted_index.patients. | 294 |
| abstract_inverted_index.pneumonia | 20 |
| abstract_inverted_index.treatment | 14 |
| abstract_inverted_index.comparable | 300 |
| abstract_inverted_index.completely | 260 |
| abstract_inverted_index.dizziness, | 245 |
| abstract_inverted_index.elevation. | 255 |
| abstract_inverted_index.randomized | 90 |
| abstract_inverted_index.identifier: | 32 |
| abstract_inverted_index.open-label, | 27 |
| abstract_inverted_index.randomized, | 26 |
| abstract_inverted_index.Sitafloxacin | 266, 295 |
| abstract_inverted_index.moxifloxacin | 11, 53, 69, 159, 193, 232, 281 |
| abstract_inverted_index.multicenter, | 25 |
| abstract_inverted_index.per-protocol | 81 |
| abstract_inverted_index.sitafloxacin | 8, 37, 67, 98, 123, 142, 150, 174, 183, 213, 222 |
| abstract_inverted_index.transaminase | 253 |
| abstract_inverted_index.(sitafloxacin | 91, 116 |
| abstract_inverted_index.CTR20130046). | 33 |
| abstract_inverted_index.moxifloxacin, | 105, 130 |
| abstract_inverted_index.moxifloxacin. | 302 |
| abstract_inverted_index.discontinuation | 262 |
| abstract_inverted_index.microbiological | 166, 197 |
| abstract_inverted_index.non-inferiority | 65 |
| abstract_inverted_index.community-acquired | 19 |
| abstract_inverted_index.study-drug-related | 204 |
| abstract_inverted_index.positive-controlled | 28 |
| abstract_inverted_index.(chinadrugtrials.org.cn | 31 |
| cited_by_percentile_year | |
| countries_distinct_count | 0 |
| institutions_distinct_count | 28 |
| citation_normalized_percentile |