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Improving Traditional Registrational Trial End Points: Development and Application of a Desirability of Outcome Ranking End Point for Complicated Urinary Tract Infection Clinical Trials.改进传统注册临床试验终点:复杂尿路感染临床试验结局排序终点的制定与应用。
Clin Infect Dis. 2023 Feb 8;76(3):e1157-e1165. doi: 10.1093/cid/ciac692.
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Distinctive Features of Ertapenem-Mono-Resistant Carbapenem-Resistant Enterobacterales in the United States: A Cohort Study.美国厄他培南单耐药碳青霉烯类耐药肠杆菌科细菌的独特特征:一项队列研究
Open Forum Infect Dis. 2021 Dec 29;9(1):ofab643. doi: 10.1093/ofid/ofab643. eCollection 2022 Jan.
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Clinical outcomes and bacterial characteristics of carbapenem-resistant Klebsiella pneumoniae complex among patients from different global regions (CRACKLE-2): a prospective, multicentre, cohort study.不同全球地区患者中耐碳青霉烯类肺炎克雷伯菌的临床结局和细菌特征(CRACKLE-2):一项前瞻性、多中心、队列研究。
Lancet Infect Dis. 2022 Mar;22(3):401-412. doi: 10.1016/S1473-3099(21)00399-6. Epub 2021 Nov 9.
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Infectious Diseases Society of America Guidance on the Treatment of Extended-Spectrum β-lactamase Producing Enterobacterales (ESBL-E), Carbapenem-Resistant Enterobacterales (CRE), and Pseudomonas aeruginosa with Difficult-to-Treat Resistance (DTR-P. aeruginosa).美国传染病学会关于产超广谱β-内酰胺酶肠杆菌科(ESBL-E)、耐碳青霉烯肠杆菌科(CRE)和治疗困难的耐药铜绿假单胞菌(DTR-P. aeruginosa)的治疗指南。
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Comparison between IMP carbapenemase-producing Enterobacteriaceae and non-carbapenemase-producing Enterobacteriaceae: a multicentre prospective study of the clinical and molecular epidemiology of carbapenem-resistant Enterobacteriaceae.产IMP 碳青霉烯酶肠杆菌科与非产碳青霉烯酶肠杆菌科的比较:碳青霉烯类耐药肠杆菌科的临床和分子流行病学多中心前瞻性研究。
J Antimicrob Chemother. 2020 Mar 1;75(3):697-708. doi: 10.1093/jac/dkz501.
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Phenotypic, biochemical and genetic analysis of KPC-41, a KPC-3 variant conferring resistance to ceftazidime-avibactam and exhibiting reduced carbapenemase activity.KPC-41的表型、生化和遗传分析,KPC-41是KPC-3的一种变体,对头孢他啶-阿维巴坦耐药且碳青霉烯酶活性降低。
Antimicrob Agents Chemother. 2019 Sep 9;63(12). doi: 10.1128/AAC.01111-19. Epub 2019 Sep 16.
8
Emergence of ceftazidime/avibactam resistance in KPC-3-producing Klebsiella pneumoniae in vivo.体内产 KPC-3 肺炎克雷伯菌出现对头孢他啶/阿维巴坦的耐药性。
J Antimicrob Chemother. 2019 Nov 1;74(11):3211-3216. doi: 10.1093/jac/dkz330.
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Reversal of carbapenemase-producing Klebsiella pneumoniae epidemiology from blaKPC- to blaVIM-harbouring isolates in a Greek ICU after introduction of ceftazidime/avibactam.在引入头孢他啶/阿维巴坦后,希腊 ICU 中产生碳青霉烯酶的肺炎克雷伯菌的流行情况从 blaKPC 到 blaVIM 携带株的逆转。
J Antimicrob Chemother. 2019 Jul 1;74(7):2051-2054. doi: 10.1093/jac/dkz125.
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Ceftazidime/avibactam resistance associated with L169P mutation in the omega loop of KPC-2.与KPC-2的ω环中L169P突变相关的头孢他啶/阿维巴坦耐药性。
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仅耐厄他培南的肠杆菌科细菌感染患者与多重碳青霉烯类耐药肠杆菌科细菌感染患者的临床结局。

Clinical outcomes in patients infected with ertapenem-only-resistant Enterobacterales versus multi-carbapenem-resistant Enterobacterales.

机构信息

Division of Infectious Diseases, Department of Medicine, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, USA.

The Biostatistics Center, George Washington University, Rockville, MD, USA.

出版信息

J Antimicrob Chemother. 2024 Aug 1;79(8):1929-1937. doi: 10.1093/jac/dkae186.

DOI:10.1093/jac/dkae186
PMID:38863337
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11290877/
Abstract

BACKGROUND

Use of anti-carbapenem-resistant Enterobacterales (anti-CRE) agents such as ceftazidime/avibactam has been associated with improved clinical outcome in cohorts that primarily include patients infected with CRE that are resistant to meropenem (MCRE).

OBJECTIVES

To clarify whether patients with CRE resistant to ertapenem but susceptible to meropenem (ertapenem-only-resistant Enterobacterales; EORE) benefit from therapy with anti-CRE agents.

METHODS

Patients treated for CRE infection in hospitals in the USA between 2016 and 2019 and enrolled in the CRACKLE-2 study were included. The primary outcome was the desirability of outcome ranking (DOOR) assessed at 30 days after index cultures.

RESULTS

The EORE group included 213 patients and the MCRE group included 643. The demographics were similar between the groups except for the patients' race and origin before admission. The MCRE group received anti-CRE agents for definitive therapy significantly more frequently compared with the EORE group (30% versus 5% for ceftazidime/avibactam). We did not observe a significant difference between the groups in the adjusted DOOR probability of a more desirable outcome for a randomly selected patient in the EORE group compared with the MCRE group (52.5%; 95% CI, 48.3%-56.7%). The MCRE group had a similar proportion of patients who died at 30 days (26% versus 21%) and who were discharged to home (29% versus 40%), compared with the EORE group.

CONCLUSIONS

Patients with clinical EORE infection rarely received anti-CRE agents, but attained similar outcomes compared with patients with MCRE infection. The findings support current IDSA treatment guidance for meropenem- or imipenem-based therapy for treatment of EORE infections.

摘要

背景

使用抗碳青霉烯类耐药肠杆菌科(anti-CRE)药物,如头孢他啶/阿维巴坦,与主要包括对美罗培南耐药的 CRE 感染患者(MCRE)的临床转归改善相关。

目的

阐明对厄他培南耐药但对美罗培南敏感的 CRE(厄他培南耐药肠杆菌科;EORE)患者是否从抗 CRE 药物治疗中获益。

方法

纳入 2016 年至 2019 年期间在美国医院接受 CRE 感染治疗并参加 CRACKLE-2 研究的患者。主要结局为 30 天后指数培养物评估的结果排序适宜性(DOOR)。

结果

EORE 组包括 213 例患者,MCRE 组包括 643 例患者。两组患者的人口统计学特征相似,除了入院前的种族和来源不同。与 EORE 组相比,MCRE 组接受抗 CRE 药物作为确定性治疗的比例显著更高(头孢他啶/阿维巴坦分别为 30%和 5%)。与 MCRE 组相比,在调整后的随机选择患者的更理想结局的 DOOR 概率方面,EORE 组没有观察到显著差异(52.5%;95%CI,48.3%-56.7%)。与 EORE 组相比,MCRE 组 30 天死亡(26%比 21%)和出院回家(29%比 40%)的患者比例相似。

结论

患有临床 EORE 感染的患者很少接受抗 CRE 药物治疗,但与患有 MCRE 感染的患者相比,获得了相似的结局。这些发现支持当前 IDSA 治疗指南中基于美罗培南或亚胺培南的治疗方案,用于治疗 EORE 感染。