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

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.

Uropathogenic Escherichia coli infection: innate immune disorder, bladder damage, and Tailin Fang II

“…Levofloxacin is a frequently prescribed antibiotic for treating urinary tract infections. Many studies have used levofloxacin as a control drug for urinary tract infections Wagenlehner et al., 2015 ; Kaye et al., 2018 ; Mo et al., 2022 ), consistently demonstrating its superior and stable efficacy compared to other antibiotics ( Li et al., 2021 ; Xue et al., 2021 ; Popa et al., 2015 ; Rouphael et al., 2023 ). Given its widespread use in clinical settings, selecting levofloxacin as a control drug may provide a more representative sample.…”

Sitafloxacin Expresses Potent Anti-Mycobacterium abscessus Activity

“…The antibacterial activity of quinolones (e.g., moxifloxacin and levofloxacin) commonly used to treat M. abscessus infections is unsatisfactory ( Choi et al, 2012a ). Sitafloxacin, a new fluoroquinolone that is effective against a broad range of bacteria, has the advantages of oral administration and superior safety ( Wu et al, 2014 ; Amano et al, 2016 ; Nakajima et al, 2016 ; Miyazaki et al, 2019 ; Mori et al, 2020 ; Li et al, 2021a , b ). Importantly, sitafloxacin exhibits antibacterial activity against M. tuberculosis and M. avium both in vitro and in vivo ( Tomioka et al, 1999 ; Sato et al, 2003 ; Asakura et al, 2019 ).…”