Ying Li1,2, Yousheng Yin3, Xiaomei Peng4, Hongguang Zheng5, Fajun Fu6, Zhenxiang Liu7, Xiongfei Wu8, Xiaoyan Wu9, Song Zheng10, Nan Chen11, Leye He12, Laicheng Ren13, Zhaohui Ni14, Detian Li15, Peiyu Liang16, Xiaoju Lv17, 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. Department of Nephrology, The Affiliated Hospital of Guilin Medical College, Guilin, China. 4. Department of Urology, People's Hospital of Guangxi Autonomous Region, Nanning, China. 5. Department of Nephrology, General Hospital of Northern Theater Command, Shenyang, China. 6. Department of Urology, Changsha Central Hospital, Changsha, China. 7. Department of Urology, Haikou People's Hospital, Haikou, China. 8. Department of Nephrology, The First Hospital Affiliated to AMU (Southwest Hospital), Chongqing, China. 9. Department of Nephrology, Zhongnan Hospital, Wuhan University, Wuhan, China. 10. Department of Urology, Union Hospital Affiliated to Fujian Medical University, Fuzhou, China. 11. Department of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. 12. Department of Urology, The Third Xiangya Hospital of Central South University, Changsha, China. 13. Department of Urology, The Second Hospital of Shanxi Medical University, Taiyuan, China. 14. Department of Nephrology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. 15. Department of Nephrology, Shengjing Hospital, China Medical University, Shenyang, China. 16. Department of Urology, The Affiliated Hospital of Hainan Medical University, Haikou, China. 17. Department of Infectious Diseases, West China Hospital, Sichuan University, Chengdu, China.
Abstract
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.
RCT Entities:
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.
Authors: Eyal Zimlichman; Daniel Henderson; Orly Tamir; Calvin Franz; Peter Song; Cyrus K Yamin; Carol Keohane; Charles R Denham; David W Bates Journal: JAMA Intern Med Date: 2013 Dec 9-23 Impact factor: 21.873
Authors: Cheol In Kang; Jieun Kim; Dae Won Park; Baek Nam Kim; U Syn Ha; Seung Ju Lee; Jeong Kyun Yeo; Seung Ki Min; Heeyoung Lee; Seong Heon Wie Journal: Infect Chemother Date: 2018-03