METHODS: An open-label, randomized, superiority, single-blind trial was conducted in Rajavithi Hospital, a super-tertiary care facility in Bangkok, Thailand. CRAB HAP/VAP patients were randomly assigned to receive either sitafloxacin-colistin-meropenem or colistin-meropenem. Outcomes in the two groups were then assessed with respect to mortality, clinical response, and adverse effects.
RESULTS: Between April 2021 and April 2022, 77 patients were treated with combinations of either sitafloxacin plus colistin plus meropenem (n = 40) or colistin plus meropenem (n = 37). There were no significant differences between the two groups with respect to all-cause mortality rates at 7 days and 14 days (respectively, 7.5% vs. 2.7%; p = 0.616, and 10% vs. 10%; p = 1). Patients who received sitafloxacin-colistin-meropenem showed improved clinical response compared with patients who received colistin-meropenem in terms of both intention-to-treat (87.5% vs. 62.2%; p = 0.016) and per-protocol analysis (87.2% vs. 67.7%; p = 0.049). There were no significant differences between the two groups with respect to adverse effects.
CONCLUSIONS: Adding sitafloxacin as a third agent to meropenem plus colistin could improve clinical outcomes in CRAB HAP/VAP with little or no impact on adverse effects. In short, sitafloxacin-meropenem-colistin could be another therapeutic option for combatting CRAB HAP/VAP.
方法:开放标签,随机化,优越性,在Rajavithi医院进行了单盲试验,曼谷的超级三级护理机构,泰国。CRABHAP/VAP患者被随机分配接受西他沙星-粘菌素-美罗培南或粘菌素-美罗培南。然后评估两组的死亡率,临床反应,和不利影响。
结果:在2021年4月至2022年4月之间,77例患者接受了西他沙星加粘菌素加美罗培南(n=40)或粘菌素加美罗培南(n=37)的组合治疗。两组在7天和14天的全因死亡率方面没有显着差异(分别是,7.5%vs.2.7%;p=0.616,10%与10%;p=1)。与接受粘菌素-美罗培南治疗的患者相比,接受西他沙星-粘菌素-美罗培南治疗的患者临床反应有所改善(87.5%vs.62.2%;p=0.016)和符合方案分析(87.2%vs.67.7%;p=0.049)。在不良反应方面,两组之间没有显着差异。
结论:在美罗培南加粘菌素中加入西他沙星作为第三种药物可以改善CRABHAP/VAP的临床结局,对不良反应影响很小或没有影响。总之,西他沙星-美罗培南-粘菌素可能是对抗CRABHAP/VAP的另一种治疗选择。