主要目的在中国健康受试者中，评估以 3 小时持续静脉输注 1.0 g 舒巴坦与 1.0 g ETX2514 单次给药后舒巴坦和 ETX2514 的药代动力学（ PK ）特征。次要目的在中国健康受试者中，评估以 3 小时持续静脉输注 1.0 g 舒巴坦与 1.0 g ETX2514 单次给药后的安全性和耐受性。

开始日期2020-08-05

申办/合作机构

再鼎医药（上海）有限公司

CTR20191711 / Completed临床3期

一项评价静脉输注ETX2514SUL治疗鲍曼不动杆菌-醋酸钙不动杆菌复合体感染患者的有效性和安全性的随机、活性对照研究

本研究的主要目的是：在A部分，比较ETX2514SUL+亚胺培南/西司他丁与多粘菌素E+亚胺培南/西司他丁治疗碳青霉烯类耐药ABC（CRABC）感染患者的有效性；以及在A部分，比较ETX2514SUL与多粘菌素E治疗ABC感染患者时肾毒性的发生率，根据风险-损伤-衰竭-肾功能丧失-终末期肾病（RIFLE）标准进行测定。本研究的次要目的是评价和比较ETX2514SUL和多粘菌素E的安全性

开始日期2020-05-07

申办/合作机构

再鼎医药（上海）有限公司

100 项与 β-lactamase x TEM 相关的临床结果

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100 项与 β-lactamase x TEM 相关的转化医学

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0 项与 β-lactamase x TEM 相关的专利（医药）

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项与 β-lactamase x TEM 相关的文献（医药）

2024-12-01·Microbial Pathogenesis

A worrisome prevalence of extended-spectrum β-lactamase producers in patients with biliary obstruction and cholangitis: Phenotypic and molecular characterization of biliary Escherichia coli and Klebsiella pneumoniae isolates

Article

作者: Sadeghi, Amir ; Harzandi, Naser ; Houri, Hamidreza ; Rabbani, Amirhassan ; Alipour, Samira

BACKGROUND & AIMSThe alarming rise of antibiotic resistance presents a substantial and worrisome issue within the context of biliary obstruction, specifically in the treatment of cholangitis. This abovementioned scenario underscores the critical importance of addressing extended spectrum β-lactamase (ESBL) producers in the biliary system to adequately tackle cholangitis using third-generation cephalosporins. Hence, we aimed to determine the frequency of ESBL and carbapenemases among biliary Escherichia coli and Klebsiella pneumoniae isolated from patients with biliary obstruction.METHODSIn this cross-sectional study, bile samples were collected via aspiration from patients diagnosed with biliary obstruction during the endoscopic retrograde cholangiopancreatography (ERCP) procedure. Subsequent culturing of these samples was performed, followed by phenotypic and molecular assessments for the detection of ESBL- and carbapenemase-producing strains of E. coli and K. pneumoniae.RESULTSApproximately 23.5 % of patients with biliary obstruction harbored biliary ESBL-producers, with the majority (70.2 %) being diagnosed with cholangitis. Moreover, 2.1 % of patients had biliary carbapenemase-producing K. pneumoniae strains. Molecular analysis confirmed the high prevalence of bla_CTX-M and bla_TEM in E. coli, and bla_TEM and bla_SHV in K. pneumoniae. Additionally, the presence of biliary K. pneumoniae harboring bla_KPC, bla_NDM, and bla_IMP was observed.CONCLUSIONOur study reveals a noteworthy observation that over half of patients experiencing biliary obstruction harbor ESBL-producing bacteria in their biliary tract. Notably, we discovered a significant link between ESBL producers and the risk of cholangitis. These findings raise important concerns regarding the suitability of employing third-generation cephalosporins as initial treatment for cholangitis and other similar biliary infections.

2024-11-01·Current Microbiology

Drug-resistant Pantoea agglomerans Causing Bacteremia at a Tertiary Care Hospital in Kolkata, India: First Report of Carbapenem Resistance Mediated by OXA-181

Article

作者: Lopes, Bruno Silvester ; Das, Surojit ; Mallick, Abhi ; Sarkar, Soma

The spread of antibiotic resistance (ABR) in uncommon human pathogens endangers global public health, escalating morbidity, death, and healthcare expenditures. Pantoea agglomerans, a member of the Erwiniaceae family that rarely infects humans, is emerging as a drug-resistant nosocomial pathogen. Seven P. agglomerans isolates were recovered from bacteremia patients at a tertiary care hospital in Kolkata, West Bengal, between March 2022 and October 2022. The isolates were evaluated for phenotypic resistance, β-lactamase and plasmid-mediated quinolone resistance (PMQR) genes, plasmid profiling, and clonality assessment. All isolates were resistant to fluoroquinolones and third-generation cephalosporins, with four resistant to carbapenems. The following β-lactamases and PMQR genes were identified: bla_OXA-1 (n = 1), bla_TEM (n = 1), bla_CTX-M-1 (n = 2), bla_NDM (n = 5), bla_OXA-181 (n = 1), qnrB (n = 2), and qnrS (n = 4). Six isolates carried up to seven plasmids ranging in size from 2 kb to > 212 kb. IncFI, FII, HI, and X3 plasmid types were detected in three isolates, while the rest remained untypable. Four different genetic patterns were noted. Four isolates were clonally related, with three being clonal. The swap of environmental isolates to human pathogens exacerbates the ABR dilemma, periling patient care and outcomes. This is the first report in India of a carbapenem-resistant P. agglomerans blood isolate carrying bla_OXA-181. In-depth genomic research of drug-resistant microbes adapted to the environment-human interfaces might underpin the source-route-containment of ABR.

2024-11-01·Journal of Infection

Survival of infection with TEM β-lactamase-producing Escherichia coli with Pan-β-lactam resistance

Article

作者: Ortiz de la Rosa, José Manuel ; Rodríguez-Villodres, Ángel ; Pardo, Francisco J Dorado ; Gálvez-Benítez, Lydia ; Cisneros, José Miguel ; Villar, Rosario Amaya ; Lepe, José Antonio ; Casimiro-Soriguer, Carlos S ; Rodríguez Rodríguez, Marta ; Rodríguez, Marta Rodríguez ; Dorado Pardo, Francisco J ; Gascón, María Luisa ; Amaya Villar, Rosario ; Peñalva, Germán ; de la Rosa, José Manuel Ortiz

BACKGROUNDAntimicrobial resistance is a critical global health issue, significantly contributing to patient mortality. Recent antibiotic developments have aimed to counteract carbapenemase-producing Enterobacterales; however, the impact of their use on the emergence of antibiotic resistance is unknown. This study investigates the first case of a non-carbapenemase-producing, pan-β-lactam-resistant Escherichia coli strain from a patient previously treated with ceftolozane-tazobactam and cefiderocol.METHODSThis study describes the clinical progression of a 39-year-old ICU patient who developed multiple infections, culminating in the isolation of a pan-β-lactam-resistant E. coli strain (EC554). The resistance profile was characterised through MIC determination, whole-genome sequencing, the use of the β-lactam inactivation method, RT-qPCR, efflux pump inhibition assays, outer membrane protein analysis, and bla_TEM transformation.FINDINGSThe EC554 isolate displayed resistance to all tested β-lactams and β-lactam-β-lactamase inhibitor combinations. Whole-genome sequencing revealed four plasmids in EC554, with the only β-lactamase gene being blaTEM-252 on the pEC554-PBR-X1-X1 plasmid. We found that the extremely resistant phenotype was attributable to a combination of different mechanisms: a high expression of TEM-252, efflux pump activity, porin loss, and PBP3 mutations.INTERPRETATIONThe findings illustrate the complex interplay of multiple resistance mechanisms in E. coli, highlighting the potential for high-level resistance even without carbapenemase production. This study underscores the importance of comprehensively characterising resistance mechanisms in order to inform effective treatment strategies and mitigate the spread of resistant strains.