A randomized, active-controlled, multicentre clinical trial to evaluate the efficacy and safety of oral sitafloxacin versus levofloxacin in Chinese adults with acute uncomplicated or complicated urinary tract infection

PURPOSE: To evaluate the efficacy and safety of oral sitafloxacin versus levofloxacin in Chinese adults with acute uncomplicated urinary tract infection (UTI) or complicated UTI. METHODS: In this randomized, active-controlled clinical trial, the patients with acute uncomplicated UTI were randomized...

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Autores principales: Li, Ying, Yin, Yousheng, Peng, Xiaomei, Zheng, Hongguang, Fu, Fajun, Liu, Zhenxiang, Wu, Xiongfei, Wu, Xiaoyan, Zheng, Song, Chen, Nan, He, Leye, Ren, Laicheng, Ni, Zhaohui, Li, Detian, Liang, Peiyu, Lv, Xiaoju, Zhang, Yingyuan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Taylor & Francis 2020
Materias:
Infectious Diseases
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7877926/
https://www.ncbi.nlm.nih.gov/pubmed/33331182
http://dx.doi.org/10.1080/07853890.2020.1861322
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author Li, Ying
Yin, Yousheng
Peng, Xiaomei
Zheng, Hongguang
Fu, Fajun
Liu, Zhenxiang
Wu, Xiongfei
Wu, Xiaoyan
Zheng, Song
Chen, Nan
He, Leye
Ren, Laicheng
Ni, Zhaohui
Li, Detian
Liang, Peiyu
Lv, Xiaoju
Zhang, Yingyuan
author_facet Li, Ying
Yin, Yousheng
Peng, Xiaomei
Zheng, Hongguang
Fu, Fajun
Liu, Zhenxiang
Wu, Xiongfei
Wu, Xiaoyan
Zheng, Song
Chen, Nan
He, Leye
Ren, Laicheng
Ni, Zhaohui
Li, Detian
Liang, Peiyu
Lv, Xiaoju
Zhang, Yingyuan
author_sort Li, Ying
collection PubMed
description PURPOSE: To evaluate the efficacy and safety of oral sitafloxacin versus levofloxacin in Chinese adults with acute uncomplicated urinary tract infection (UTI) or complicated UTI. METHODS: In this randomized, active-controlled clinical trial, the patients with acute uncomplicated UTI were randomized to receive sitafloxacin 100-mg once-daily (qd) or levofloxacin 500-mg qd orally for 3–5 days. The patients with complicated UTI were randomized to receive sitafloxacin 100-mg twice daily or levofloxacin 500-mg qd orally for 10–14 days. The primary endpoint was the clinical efficacy at test-of-cure (TOC) visit. RESULTS: At TOC visit, the clinical cure rate was 89.2% (58/65) in sitafloxacin group and 97.1% (68/70) in levofloxacin group for the patients with acute uncomplicated UTI corresponding to the bacterial eradication rate of 97.1% (34/35) and 97.6% (41/42) (all p > .05), respectively. For the patients with complicated UTI, the clinical cure rate was 81.8% (27/33) in sitafloxacin group and 76.9% (20/26) in levofloxacin group corresponding to the bacterial eradication rate of 93.3% (14/15) and 63.6% (7/11) (all p > .05), respectively. Sitafloxacin and levofloxacin showed similar incidence of drug-related adverse events. CONCLUSIONS: Oral sitafloxacin is as effective and safe as levofloxacin in treating acute uncomplicated and complicated UTI. KEY MESSAGE: Oral sitafloxacin showed similar clinical cure rate and bacterial eradication rate as levofloxacin for treatment of complicated and uncomplicated urinary tract infections (UTIs) in a randomized, active-controlled, multicentre clinical trial. Oral sitafloxacin is safe and well-tolerated in treating acute uncomplicated and complicated UTIs in Chinese adults. Sitafloxacin is a promising alternative treatment option for UTIs in adults.
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spelling pubmed-78779262021-03-11 A randomized, active-controlled, multicentre clinical trial to evaluate the efficacy and safety of oral sitafloxacin versus levofloxacin in Chinese adults with acute uncomplicated or complicated urinary tract infection Li, Ying Yin, Yousheng Peng, Xiaomei Zheng, Hongguang Fu, Fajun Liu, Zhenxiang Wu, Xiongfei Wu, Xiaoyan Zheng, Song Chen, Nan He, Leye Ren, Laicheng Ni, Zhaohui Li, Detian Liang, Peiyu Lv, Xiaoju Zhang, Yingyuan Ann Med Infectious Diseases PURPOSE: To evaluate the efficacy and safety of oral sitafloxacin versus levofloxacin in Chinese adults with acute uncomplicated urinary tract infection (UTI) or complicated UTI. METHODS: In this randomized, active-controlled clinical trial, the patients with acute uncomplicated UTI were randomized to receive sitafloxacin 100-mg once-daily (qd) or levofloxacin 500-mg qd orally for 3–5 days. The patients with complicated UTI were randomized to receive sitafloxacin 100-mg twice daily or levofloxacin 500-mg qd orally for 10–14 days. The primary endpoint was the clinical efficacy at test-of-cure (TOC) visit. RESULTS: At TOC visit, the clinical cure rate was 89.2% (58/65) in sitafloxacin group and 97.1% (68/70) in levofloxacin group for the patients with acute uncomplicated UTI corresponding to the bacterial eradication rate of 97.1% (34/35) and 97.6% (41/42) (all p > .05), respectively. For the patients with complicated UTI, the clinical cure rate was 81.8% (27/33) in sitafloxacin group and 76.9% (20/26) in levofloxacin group corresponding to the bacterial eradication rate of 93.3% (14/15) and 63.6% (7/11) (all p > .05), respectively. Sitafloxacin and levofloxacin showed similar incidence of drug-related adverse events. CONCLUSIONS: Oral sitafloxacin is as effective and safe as levofloxacin in treating acute uncomplicated and complicated UTI. KEY MESSAGE: Oral sitafloxacin showed similar clinical cure rate and bacterial eradication rate as levofloxacin for treatment of complicated and uncomplicated urinary tract infections (UTIs) in a randomized, active-controlled, multicentre clinical trial. Oral sitafloxacin is safe and well-tolerated in treating acute uncomplicated and complicated UTIs in Chinese adults. Sitafloxacin is a promising alternative treatment option for UTIs in adults. Taylor & Francis 2020-12-17 /pmc/articles/PMC7877926/ /pubmed/33331182 http://dx.doi.org/10.1080/07853890.2020.1861322 Text en © 2020 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group https://creativecommons.org/licenses/by/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Infectious Diseases
Li, Ying
Yin, Yousheng
Peng, Xiaomei
Zheng, Hongguang
Fu, Fajun
Liu, Zhenxiang
Wu, Xiongfei
Wu, Xiaoyan
Zheng, Song
Chen, Nan
He, Leye
Ren, Laicheng
Ni, Zhaohui
Li, Detian
Liang, Peiyu
Lv, Xiaoju
Zhang, Yingyuan
A randomized, active-controlled, multicentre clinical trial to evaluate the efficacy and safety of oral sitafloxacin versus levofloxacin in Chinese adults with acute uncomplicated or complicated urinary tract infection
title A randomized, active-controlled, multicentre clinical trial to evaluate the efficacy and safety of oral sitafloxacin versus levofloxacin in Chinese adults with acute uncomplicated or complicated urinary tract infection
title_full A randomized, active-controlled, multicentre clinical trial to evaluate the efficacy and safety of oral sitafloxacin versus levofloxacin in Chinese adults with acute uncomplicated or complicated urinary tract infection
title_fullStr A randomized, active-controlled, multicentre clinical trial to evaluate the efficacy and safety of oral sitafloxacin versus levofloxacin in Chinese adults with acute uncomplicated or complicated urinary tract infection
title_full_unstemmed A randomized, active-controlled, multicentre clinical trial to evaluate the efficacy and safety of oral sitafloxacin versus levofloxacin in Chinese adults with acute uncomplicated or complicated urinary tract infection
title_short A randomized, active-controlled, multicentre clinical trial to evaluate the efficacy and safety of oral sitafloxacin versus levofloxacin in Chinese adults with acute uncomplicated or complicated urinary tract infection
title_sort randomized, active-controlled, multicentre clinical trial to evaluate the efficacy and safety of oral sitafloxacin versus levofloxacin in chinese adults with acute uncomplicated or complicated urinary tract infection
topic Infectious Diseases
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7877926/
https://www.ncbi.nlm.nih.gov/pubmed/33331182
http://dx.doi.org/10.1080/07853890.2020.1861322
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