Efficacy and Safety of Sitafloxacin in the Treatment of Acute Bacterial Infection: A Meta-analysis of Randomized Controlled Trials

• Published in: Antibiotics (Basel) Vol. 9; no. 3; p. 106
• Main Authors: Chen, Chao-Kun, Cheng, I-Ling, Chen, Yu-Hung, Lai, Chih-Cheng
• Format: Journal Article
• Language: English
• Published: Switzerland MDPI AG 02.03.2020; MDPI
• Subjects: acute bacterial infection; acute pyelonephritis; Antibiotics; Bacteria; Bacterial diseases; Bacterial infections; Bias; Clinical trials; Comparators; complicated urinary tract infection; Dosage and administration; Fluoroquinolones; Infections; Medical research; Meta-analysis; Mortality; Pathogens; Patients; Pneumonia; Population; Pyelonephritis; Randomization; Response rates; Safety; Sensitivity analysis; sitafloxacin; Software reviews; Streptococcus infections; Studies; Urinary tract; Urinary tract diseases; Urinary tract infections; Urogenital system; Japan; Taiwan; acute pyelonephritis; sitafloxacin; acute bacterial infection; pneumonia; complicated urinary tract infection
• ISSN: 2079-6382; 2079-6382
• DOI: 10.3390/antibiotics9030106

This meta-analysis aimed to assess the efficacy and safety of sitafloxacin in treating acute bacterial infection. PubMed, Embase, and Cochrane databases were searched up to August 13, 2019. Only randomized controlled trials (RCTs) evaluating sitafloxacin and comparators in the treatment of acute bacterial infections were included. The outcomes were clinical and microbiological responses and the risk of adverse event (AE). Five RCTs were enrolled, including 375 and 381 patients who received sitafloxacin and the comparator, respectively. Overall, the clinical response rate of sitafloxacin in the treatment of acute bacterial infections was 94.6%, which was noninferior to that of the comparator (92.5%) (odds ratio (OR), 1.01; 95% CI, 0.24-4.32; = 66%). For patients with complicated urinary tract infection (cUTI)/acute pyelonephritis (APN), the clinical response rate of sitafloxacin and the comparator was 96.9% and 91.3%, respectively (OR, 2.08; 95% CI, 0.35-12.44; = 54%). For patients with pneumonia, the clinical response rate of sitafloxacin was 88.6%, which was comparable to that of the comparator (OR, 0.36; 95% CI, 0.11-1.21; = 0%). The microbiological response of sitafloxacin was 82.0%, which was noninferior to that of the comparator (77.8%) (OR, 1.59; 95% CI, 0.77-3.28; = 47%). The risk of treatment-emergent adverse event (TEAE), drug-related TEAE, and all-cause mortality were similar between sitafloxacin and the comparators (TEAE, OR, 1.14; 95% CI, 0.64-2.01, drug-related TEAE, OR, 1.14; 95% CI, 0.48-2.69, mortality, OR, 0.93; 95% CI, 0.09-9.44). In conclusion, sitafloxacin is noninferior to other commonly used antibiotics with respect to both clinical and microbiological response rates in patients with an acute bacterial infection, including cUTI/APN and pneumonia. In addition, sitafloxacin is also as safe as the comparators.