The efficacy and adverse events of delafloxacin in the treatment of acute bacterial infections: A systematic review and meta-analysis of randomized controlled trials.

Abstract

Background: This study aims to assess the clinical efficacy and adverse events of delafloxacin for the treatment of acute bacterial infections in adult patients through meta-analysis. Methods: The PubMed, Embase, Cochrane library, Web of Science, and Clinical trails databases were searched up to 26 March 2022. Only randomized controlled trials (RCTs) that evaluated delafloxacin and comparator antibiotics for treating acute bacterial infections in adult patients were included. The clinical cure rate and microbiological eradication rate at the posttreatment evaluation, while the secondary outcomes included the risk of adverse events (AEs). Results: In total, six randomized controlled trials (RCTs) involving 3,019 patients with acute bacterial infection were included. There were no significant differences in the clinical cure rate between delafloxacin and comparators (OR = 1.06%, 95% CI = 0.89–1.26, I2 = 0%). Overall, the results showed that delafloxacin had a microbiological eradication rate (documented and presumed) similar to the comparators (OR = 1.33%, 95% CI = 0.94–1.88, I2 = 0%) in the pooled analysis of the six studies. Any treatment-emergent adverse events (TEAEs) did not show significant differences between delafloxacin and the comparators (OR = 0.93%, 95% CI = 0.80–1.08, I2 = 75%). Serious adverse events (SAEs) did not differ between the delafloxacin and comparators (OR = 0.94%, 95% CI = 0.67–1.32, I2 = 0%). The results of gastrointestinal disorders were (OR = 1.26%, 95% CI = 1.01–1.56, I2 = 89%), and nausea, vomiting, and diarrhea were (OR = 0.77%, 95% CI = 0.45–1.34, I2 = 79%), (OR = 1.00%, 95% CI = 0.74–1.36, I2 = 72%), and (OR = 2.10%, 95% CI = 1.70–2.96, I2 = 0%), respectively. The results showed that there was no significant difference in the incidence of nausea and vomiting between delafloxacin and the comparator, but the incidence of diarrhea was higher. The analysis of neurological disorders indicated that the incidence of nervous system disorders was lower in the delafloxacin group (OR = 0.71%, 95% CI = 0.50–1.01, I2 = 52%). Conclusion: The clinical efficacy, microbiological eradication rate and the incidence of AEs of delafloxacin in the treatment of acute bacterial infections were similar to those of the comparators, as an alternative therapeutic agent.