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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.
- Source :
- Annals of Medicine; Jan2021, Vol. 53 Issue 1, p217-226, 10p
- Publication Year :
- 2021
-
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. [ABSTRACT FROM AUTHOR]
- Subjects :
- URINARY tract infections
CLINICAL trials
ADULTS
Subjects
Details
- Language :
- English
- ISSN :
- 07853890
- Volume :
- 53
- Issue :
- 1
- Database :
- Complementary Index
- Journal :
- Annals of Medicine
- Publication Type :
- Academic Journal
- Accession number :
- 154419378
- Full Text :
- https://doi.org/10.1080/07853890.2020.1861322