Tiseo Giusy, Galfo Valentina, Riccardi Niccolò, Suardi Lorenzo Roberto, Pogliaghi Manuela, Giordano Cesira, Leonildi Alessandro, Barnini Simona, Falcone Marco
Infectious Diseases Unit, Department of Clinical and Experimental Medicine, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.
Microbiology Unit, Azienda Ospedaliera Universitaria Pisana, Pisa, Italy.
Eur J Clin Microbiol Infect Dis. 2024 Feb 20. doi: 10.1007/s10096-024-04758-2.
Real-world experience with meropenem/vaborbactam (M/V) is limited. Our aim is to report a clinical experience of M/V in the treatment of resistant Gram-negative bacilli.
This is a prospective observational study including patients hospitalized in the University Hospital of Pisa (March 2021-Jan 2023) with infections by both extended-spectrum β-lactamases (ESBL)-producing Enterobacterales and carbapenem-resistant Klebsiella pneumoniae (Kp) treated with M/V. The primary outcome measure was clinical success, defined as a composite of survival, resolution of signs and symptoms and absence of microbiological failure at day 30 from infection onset. A multivariable regression analysis was performed to identify factors associated with clinical failure. Odds ratio (OR) with 95% confidence intervals (CI) was calculated.
A total of 104 patients who received M/V were included: 24/104 (23.1%) infections were caused by ESBL non-hypervirulent Enterobacterales, 17/104 (16.3%) by ESBL-producing hypervirulent Klebsiella pneumoniae (hvKp) and 63/104 (60.6%) by CRE. The most common infections were bloodstream infections, followed by urinary tract infections, hospital-acquired pneumonia, intra-abdominal infections and others. Septic shock occurred in 16/104 (15.4%) patients. Clinical success was achieved in 77% of patients, and 30-day mortality rate was 15.4%. In patients with KPC-producing Kp infections, clinical success and 30-day mortality rates were 82% and 11.5%, respectively. On multivariable analysis, SOFA score (OR 1.32, 95% CI 1.02-1.7, p=0.032) was independently associated with clinical failure, while source control (OR 0.16, 95% CI 0.03-0.89, p=0.036) was protective.
M/V is a promising therapeutic option against infections caused by difficult-to-treat ESBL-producing Enterobacterales and CR-Kp.
美罗培南/瓦博巴坦(M/V)的真实世界经验有限。我们的目的是报告M/V治疗耐药革兰氏阴性杆菌的临床经验。
这是一项前瞻性观察性研究,纳入了在比萨大学医院住院(2021年3月至2023年1月)且感染产超广谱β-内酰胺酶(ESBL)肠杆菌科细菌和耐碳青霉烯肺炎克雷伯菌(Kp)并接受M/V治疗的患者。主要结局指标为临床成功,定义为自感染起30天时生存、体征和症状缓解且无微生物学失败的综合情况。进行多变量回归分析以确定与临床失败相关的因素。计算比值比(OR)及95%置信区间(CI)。
共纳入104例接受M/V治疗的患者:24/104(23.1%)例感染由ESBL非高毒力肠杆菌科细菌引起,17/104(16.3%)例由产ESBL高毒力肺炎克雷伯菌(hvKp)引起,63/104(60.6%)例由耐碳青霉烯肠杆菌科细菌(CRE)引起。最常见的感染是血流感染,其次是尿路感染、医院获得性肺炎、腹腔内感染及其他感染。16/104(15.4%)例患者发生感染性休克。77%的患者取得临床成功,30天死亡率为15.4%。在产KPC的Kp感染患者中,临床成功率和30天死亡率分别为82%和11.5%。多变量分析显示,序贯器官衰竭评估(SOFA)评分(OR 1.32,95%CI 1.02 - 1.7,p = 0.032)与临床失败独立相关,而感染源控制(OR 0.16,95%CI 从0.03至0.89,p = 0.036)具有保护作用。
M/V是治疗由难治性产ESBL肠杆菌科细菌和耐碳青霉烯Kp引起的感染的一种有前景的治疗选择。