| Summary: | The in vitro study of sitafloxacin against carbapenem-resistant (CR) <i>Acinetobacter baumannii</i> demonstrated activity against most strains of CR <i>A. baumannii</i>, and the combination of colistin and sitafloxacin showed an in vitro synergistic effect against CR <i>A. baumannii</i>. This study aimed to compare efficacy and safety between colistin plus sitafloxacin with colistin alone for therapy for CR <i>A. baumannii</i> infection. This randomized controlled trial enrolled 56 patients with CR <i>A. baumannii</i> infection (28/group) during 2018–2021, and the treatment duration was 7–14 days. The study outcomes were 28-day mortality, clinical and microbiological responses, and adverse events. There was no significant difference in 28-day mortality between groups (32.1% combination vs. 32.1% monotherapy, <i>p</i> = 1.000). Favorable clinical response at the end of treatment was comparable between groups (81.5% combination vs. 77.8% monotherapy, <i>p</i> = 0.788). Microbiological response at the end of treatment was also comparable between groups (73.1% combination vs. 74.1% monotherapy, <i>p</i> = 0.934). Acute kidney injury was found in 53.8% of the combination group, and in 45.8% of the monotherapy group (<i>p</i> = 0.571). In conclusion, there was no significant difference in 28-day mortality between the colistin monotherapy and the colistin plus sitafloxacin groups. There was also no significant difference in adverse events between groups.
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