Background:
Non-small cell lung cancer (NSCLC) can be hard to treat and is often fatal. People with NSCLC commonly have changes in the bacteria that populate their lungs. These bacterial changes may aid tumor growth. Researchers want to find out if treating the bacteria, too, can help cancer treatment work better.
Objective:
To test 2 inhaled antibiotics (aztreonam and vancomycin), combined with a standard cancer treatment, in people with NSCLC.
Eligibility:
People aged 18 years and older with NSCLC that has returned or progressed after treatment and cannot be treated with surgery.
Design:
Participants will be screened. They will have a physical exam with blood tests. They may blow into a machine to test how well their lungs work. They will have imaging scans. They may need to have a small piece of tissue cut from their tumor (biopsy).
Participants will be treated in six 21-day cycles. They will visit the clinic to receive a drug for cancer treatment on the first day of each cycle. This drug will be administered through a tube attached to a needle inserted into a vein in the arm.
The 2 antibiotic drugs will be in the form of a fine mist that can be inhaled. Participants use a device to take these drugs at home. They will inhale aztreonam up to 3 times a day and vancomycin 1 or 2 times a day. They will take these drugs during only 3 of the treatment cycles.
Biopsies and other tests will be repeated halfway through and after the study treatment.
Follow-up visits will continue for 1 year after study treatment.

开始日期2024-04-18

申办/合作机构

National Cancer Institute

CTR20233006 / Recruiting临床3期

一项评价头孢吡肟/Nacubactam或氨曲南/Nacubactam与亚胺培南/西司他丁相比在治疗成人复杂性尿路感染或急性单纯性肾盂肾炎中的有效性和安全性的III期、多中心、随机、双盲研究

主要目的：在cUTI或AP患者中与亚胺培南/西司他丁相比，评价静脉输注头孢吡肟/Nacubactam的有效性和安全性以及氨曲南/Nacubactam的安全性。次要目的：评价氨曲南/Nacubactam静脉输注给药治疗cUTI或AP的有效性；评价头孢吡肟/Nacubactam和氨曲南/Nacubactam静脉输注给药治疗cUTI或AP继发性菌血症的有效性；评价头孢吡肟/Nacubactam和氨曲南/Nacubactam静脉输注给药在cUTI或AP患者中的药代动力学（PK）；按病原体类型、耐药类型和抗菌药物敏感性评价头孢吡肟/Nacubactam和氨曲南/Nacubactam静脉输注给药的临床和微生物学反应。

开始日期2024-02-27

申办/合作机构

上海复星医药产业发展有限公司

CTR20233005 / Recruiting临床3期

一项评估头孢吡肟/Nacubactam和氨曲南/Nacubactam与现有最佳治疗方法相比在治疗成人因耐碳青霉烯肠杆菌引起的复杂性尿路感染、急性单纯性肾盂肾炎、医院获得性细菌性肺炎、呼吸机相关性细菌性肺炎和复杂性腹腔感染的有效性和安全性的III期、多中心、随机、单盲研究

主要目的：使用总体治疗成功的复合终点，评估静脉（IV）输注头孢吡肟/Nacubactam和氨曲南/Nacubactam治疗所有耐碳青霉烯肠杆菌（CRE）感染类型（即cUTI、AP、HABP、VABP和cIAI）的有效性；评估静脉输注头孢吡肟/Nacubactam和氨曲南/Nacubactam的安全性。次要目的：评估IV输注头孢吡肟/Nacubactam和氨曲南/Nacubactam治疗每种感染类型（即cUTI、AP、HABP、VABP和cIAI）引起的继发性菌血症患者的有效性；评估静脉输注头孢吡肟/Nacubactam和氨曲南/Nacubactam治疗每种CRE感染类型（即cUTI、AP、HABP、VABP和cIAI）的有效性；评估每种感染类型（即cUTI、AP、HABP、VABP和cIAI）静脉输注头孢吡肟/Nacubactam和氨曲南/Nacubactam的药代动力学（PK）；按病原体类型、耐药类型和抗菌药物敏感性评价头孢吡肟/Nacubactam和氨曲南/Nacubactam静脉输注给药的临床和微生物学反应。

开始日期2024-02-19

申办/合作机构

上海复星医药产业发展有限公司

100 项与氨曲南相关的临床结果

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100 项与氨曲南相关的转化医学

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100 项与氨曲南相关的专利（医药）

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3,689

项与氨曲南相关的文献（医药）

2024-12-01·Molecular Biology Reports

Detection of phylogrouping, adhesin, and extended spectrum β-lactamases genes in hospital acquired uropathogenic Escherichia coli isolates

Article

作者: El Azawy, Doaa Sh ; El-Sayed, Hend Abdalla ; Fahmy, Yasmin Ahmed ; Orabi, Eman Elshahat ; Hussein, Samia ; El Maghraby, Hanaa M ; Attia, Osama

BACKGROUND:

It has been interesting to compare the levels of antimicrobial resistance and the virulence characteristics of uropathogenic Escherichia coli (UPEC) strains of certain phylogenetic groups. The purpose of this study was to identify the frequency of phylogenetic groups, adhesin genes, antibiotic sensitivity patterns, and extended spectrum-lactamases (ESBLs) genes in hospital-acquired UPEC.

METHODS:

After UPEC isolation, the disc diffusion method was used to assess its susceptibility to antibiotics. Combination disc testing confirmed the existence of ESBL producers. Polymerase chain reaction (PCR) was used to detect genes for adhesin and ESBLs.

RESULTS:

One hundred and twenty-eight E. coli were isolated which had the highest resistance to tetracycline (96%) followed by cefoxitin (93%), cefepime (92%), ceftazidime (79%), aztreonam (77%) and sulfamethoxazole -trimethoprim (75%). About 57% of isolates were phenotypically ESBLs positive and they were confirmed by PCR. B2 phylogroup (41%) was the most frequent in E. coli isolates then group D (30%), group A (18%), and lastly group B1 (11%). ESBLs genes were more significantly prevalent in phylogroups B2 and D than other phylogroups (P < 0.001). Regarding adhesin genes, both fim H and afa were more significantly associated with group B2 than other groups (P < 0.009, < 0.032), respectively. In ESBL-positive isolates, both genes were more significantly detected compared to negative ones (P < 0.001).

CONCLUSION:

Phylogroups B2 and D of UPEC are important reservoirs of antimicrobial resistance and adhesion genes. Detection of ESBL-producing E. coli is important for appropriate treatment as well as for effective infection control in hospitals.

2024-03-01·Journal of Global Antimicrobial Resistance

First detection in Spain of NDM-1-producing Pseudomonas aeruginosa in two patients transferred from Ukraine to a university hospital

Article

作者: Cobo, Javier ; Cabello, Margarita ; Herrador-Gómez, Pedro M ; Gioia, Francesca ; Hernández-García, Marta ; Cantón, Rafael ; Ruiz-Garbajosa, Patricia ; Ponce-Alonso, Manuel

OBJECTIVES:

Carbapenemase-mediated carbapenem resistance in Pseudomonas aeruginosa is a relevant health problem. We detected for the first time in Spain two clinical NDM-producing P. aeruginosa (NDM-Pa) isolates in two Ukrainian patients admitted to our hospital between April and August 2022.

METHODS:

Antimicrobial susceptibility was studied by microdilution and MIC gradient strips (EUCAST-2022 criteria). Carbapenemase genes were detected by the Xpert Carba-R and immunochromatography assays. WGS (Illumina and Oxford-Nanopore) was also performed.

RESULTS:

In May 2022, we detected an NDM-Pa in a sternotomy wound in a patient. In June-2022, a second NDM-Pa along with an OXA-48-Klebsiella pneumoniae (OXA-48-Kp) isolate was detected in a mandibular abscess from an unrelated patient. Moreover, an NDM+OXA-48-K. pneumoniae (NDM+OXA-48-Kp) was also found in a rectal sample of this patient. Both patients had undergone surgery in Ukraine before their transfer to our hospital. NDM-Pa isolates were resistant to all tested antimicrobials with the exception of aztreonam (MIC = 8 mg/L), colistin (MIC =2 mg/L) and cefiderocol (MIC range = 0.75-2 mg/L). WGS confirmed that both P. aeruginosa isolates were NDM-1 producers, belonged to ST773 and shared an identical resistome. bla_NDM-1 was located on a ∼117-Kb chromosomally integrated integrative conjugative element (ICE). OXA-48-Kp and NDM+OXA-48-Kp belonged to ST147 and contained bla_OXA-48 on an identical ∼300-Kb IncHIB-plasmid. bla_NDM-1 was located on a 51-Kb IncFIB-plasmid only found in NDM+OXA-48-Kp.

CONCLUSIONS:

This is the first description of NDM-Pa in Spain. We highlight the threat of further cross-border dissemination of NDM-1 through P. aeruginosa along with K. pneumoniae high-risk clones also carrying OXA-48, which draws a complex epidemiological scenario.

2024-03-01·Journal of Global Antimicrobial Resistance

The occurrence of the carbapenemase gene, blaNDM-5, on a transmissible IncX3 plasmid in multidrug-resistant Escherichia coli isolated from a farm dog

Article

作者: Kassem, Issmat I ; Oueslati, Saoussen ; Osman, Marwan ; Dabboussi, Fouad ; Daaboul, Dina ; Naas, Thierry ; El Omari, Khaled

OBJECTIVES:

In-depth phenotypic and genomic analyses on a carbapenem-resistant Escherichia coli isolate, recovered from the faeces of a farm dog in Lebanon, focusing on its antimicrobial resistance (AMR) patterns and the underlying resistome.

METHODS:

E. coli strain EC-106 was identified using MALDI-TOF-MS. Analyses using Carba NP, immunochromatographic assay NG Carba5, and other antimicrobial susceptibility testing were performed. Whole-genome sequencing (WGS) using the Illumina technology and different software available at the Center of Genomic Epidemiology wwere used to predict the resistome, sequence type (ST), plasmid types, and virulence genes.

RESULTS:

Susceptibility testing revealed that E. coli EC-106 was multi-drug resistant, including against newer antimicrobials such as imipenem-relebactam (MIC = 16 µg/mL), meropenem-vaborbactam (MIC = 16 µg/mL), and ceftazidime-avibactam (MIC > 32 µg/mL), but remained susceptible to aztreonam (MIC = 0.12 µg/mL), aztreonam-avibactam (MIC = 0.06 µg/mL), and cefiderocol (MIC = 0.5 µg/mL). WGS analyses showed that E. coli EC-106 carried 13 acquired resistance genes associated with resistance to β-lactams (bla_NDM-5 and bla_TEM-1B), aminoglycosides (aac(3)-IId, aph(3')-Ia, aadA1, and aadA2), tetracyclines (tetA), amphenicols (partial catA1), macrolides (mphA), sulphonamides (sul1 and sul3), trimethoprim (dfrA12), and quaternary ammonium compounds (partial qacE). The bla_NDM-5 was located on an IncX3 plasmid. The isolate was predicted to be a human pathogen (92.9%) and belonged to ST1011.

CONCLUSION:

To our knowledge, this is the first report of the detection of an IncX3 plasmid carrying the bla_NDM-5 gene in animals in Lebanon, highlighting the severe AMR challenges in the country. Taken together, our current and previous findings suggest that bla_NDM-5 might be spreading in different hosts and genetic backgrounds across clinical and non-clinical settings.

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2024-04-23

·药研发

【药研发0424】鞍石脑胶质瘤新药获批上市 | 熙源安健融资开发止痛新药...

「本文共：15条资讯，阅读时长约：3分钟」今日头条鞍石脑胶质瘤新药获批上市。鞍石生物旗下浦润奥生物c-Met抑制剂伯瑞替尼肠溶胶囊获国家药监局批准新适应症，用于治疗经放疗和替莫唑胺（TMZ）治疗后复发或不可耐受的、具有PTPRZ1-MET（ZM）融合基因的异柠檬酸脱氢酶（IDH）突变型WHO 4级星形细胞瘤或既往有较低级别病史的胶质母细胞瘤（GBM）成人患者。在Ⅱ/Ⅲ期临床中，伯瑞替尼相比化疗降低了患者48%的死亡风险。国内药讯1.传奇/强生CAR-T获批新适应症。传奇生物与强生开发的BMCA CAR-T疗法西达基奥仑赛（Carvykti，cilta-cel）获欧盟委员会（EC）批准，用于治疗至少经一线治疗（包括蛋白酶体抑制剂和免疫调节剂）、并对来那度胺耐药的复发和难治性多发性骨髓瘤（RRMM）患者。在III期CARTITUDE-4研究中，Carvyktii二线治疗改善了患者无进展生存期（HR=0.41，p<0.0001）。2022年5月，该新药已被EC附条件批准上市，治疗至少接受过3种前期疗法的RRMM患者。2.信达引进胆管癌新药获批澳门上市。信达生物从Incyte引进的FGFR1/2/3抑制剂pemigatinib（达伯坦）获澳门药监部门（ISAF）批准上市，用于治疗FGFR2融合或重排、局部晚期或转移性胆管癌经治患者。在Ⅱ期临床FIGHT202中，pemigatinib在这类患者中经影像学确认的ORR达到37.0%（95% CI: 27.94%, 46.86%），中位DOR为8.08个月。信达拥有该新药在中国大陆、香港、澳门和台湾地区的商业化权益。3.百利天恒双抗ADC获批II期临床。百利天恒HER3/EGFR双抗ADC创新药BL-B01D1获国家药监局临床默示许可，即将开展评估BL-B01D1与PD-1抑制剂信迪利单抗双药不联合或联合化疗治疗局部晚期或转移性非小细胞肺癌患者的Ⅱ期临床。BL-B01D1此前已被CDE拟纳入突破性治疗品种，用于既往经PD-1/PD-L1单抗治疗且经至少两线化疗（至少一线含铂）治疗失败的复发性或转移性鼻咽癌（NPC）患者。4.华东双靶点减肥药获批美国临床。华东医药旗下中美华东GLP-1R/GIPR双靶点激动剂HDM1005获FDA批准开展Ⅰ期临床，用于成人超重或肥胖人群的体重管理。HDM1005可通过激活GLP-1受体和GIP受体，促进胰岛素释放、抑制食欲，具有降糖和减重的潜力。今年3月，该新药已在国内获批临床许可，拟开发用于2型糖尿病和超重或肥胖人群的体重管理。5.熙源安健融资开发止痛新药。熙源安健宣布完成超亿元Pre-A和Pre-A+融资，用于推进产品管线疼痛管理领域创新性候选药物（BR005和BR01T等）的临床开发。BR005是一款小分子CGRPR拮抗剂，旨在选择性结合CGRP受体以抑制该通路，从而发挥治疗作用，目前正在国内开展用于治疗成人有先兆或无先兆急性偏头痛的Ⅰ期临床。BR01T是一款TrkA抗体，正在美国针对慢性下腰痛患者开展Ⅰ期临床。国际药讯1.ImmunityBio公司膀胱癌新药获批上市。ImmunityBio公司IL-15超级激动剂Anktiva（nogapendekin alfa inbakicept）获FDA批准上市，联合卡介苗（BCG）用于治疗对BCG无应答且伴有原位癌（CIS）的非肌层浸润性膀胱癌（NMIBC）成年患者。在II/III期研究QUILT 3.032中，患者的完全缓解（CR）率达到62%（95% CI：51，73），有58%的患者持续缓解时间超过12个月，40%的患者持续缓解时间超过24个月。此前，FDA已授予Anktiva突破性疗法认定。2.辉瑞/艾伯维复方抗生素获批上市。辉瑞制药与艾伯维联合开发的复方抗生素Emblaveo（aztreonam/avibactam）获欧盟委员会（EC）批准上市，用于治疗成人复杂性腹腔内感染（cIAI）、医院获得性肺炎（HAP，包括呼吸机相关性肺炎[VAP]），以及复杂性尿路感染（cUTI，包括肾盂肾炎）。在Ⅲ期研究中，Emblaveo的治愈率相比活性对照药物达到了非劣效标准，对cIAI患者的治愈率达到76.4%（vs74.0%），对于HAP和VAP的治愈率达到45.9%（vs41.7%）。3.拜耳心衰基因疗法获快速通道资格。拜耳旗下公司Asklepios基因疗法AB-1002获FDA授予快速通道资格，用于一次性冠状动脉内输注，治疗充血性心力衰竭（CHF）。AB-1002旨在促进产生CHF相关蛋白质抑制剂1（I-1c）的组成型活性形式，阻断蛋白磷酸酶1的作用，以达到治疗目的。目前，AB-1002正在Ⅱ期临床中评估用于治疗患有非缺血性心肌病伴有纽约心脏病协会（NYHA）III级心衰症状的成年患者的安全性和有效性。4.血癌小分子新药获突破性疗法认定。Kura Oncology公司选择性menin抑制剂ziftomenib获FDA授予突破性疗法认定，用于治疗携带NPM1基因突变的复发/难治性急性髓系白血病（AML）患者。在Ⅰ期临床KOMET-007中，ziftomenib联合标准疗法一线治疗NPM1突变型和KMT2A重排型AML患者，达到了100%的完全缓解（CR）率；在难治/复发（R/R）性AML患者中，达到了56%的完全缓解或完全缓解伴部分血液学恢复（CRh）率。5.卫材与BioArctic公司再次合作开发AD新药。卫材与BioArctic公司就后者基于专有穿越血脑屏障技术开发的下一代阿尔茨海默病（AD）候选药物BAN2802达成合作许可协议。双方将共同分担研究评估计划的费用，卫材将拥有开发BAN2802用于治疗AD的选择权。值得一提的是，两家公司此前合作开发的Aβ抗体Leqembi（lecanemab）已在去年7月获得FDA完全批准上市，可以减缓早期阿尔茨海默病的进展。6.Marinus公司癫痫调节剂Ⅲ期临床失败。Marinus公司GABAAR正变构调节剂加奈索酮（Ganaxolone）治疗难治性癫痫持续状态（RSE）的Ⅲ期临床RAISE未达到预设的终止标准。独立数据监测委员会（DMC）建议继续评估经静脉注射Ganaxolone在难治性RSE的未来发展。2022年3月，FDA已批准该产品口服混悬制剂上市，商品名为ZTALMY，用于治疗与CDKL5缺乏症（CDD）相关的癫痫发作。医药热点1.石药创新制药高管辞任。石药创新制药（新诺威）发布公告，宣布董事会收到总经理韩峰先生及董事王怀玉先生的书面辞任报告。因工作调整需要，韩峰先生申请辞任公司总经理职务，将继续担任公司董事职务，并分管公司功能性原料相关业务。王怀玉先生因个人原因申请辞任公司董事职务，辞职后不再担任公司任何职务。2.全国胰岛素集中采购在上海开标。国家医保局近期组织全国各省份开展胰岛素集采协议期满后接续采购，并于23日在上海开标。本次接续采购全国共有35000多家医疗机构参加，填报胰岛素需求量超过2.4亿支，涵盖临床常用的二代和三代胰岛素。2021年11月，国家组织胰岛素集中采购首次将生物药纳入集采范围，中选产品平均降价48%，我国胰岛素价格从全球价格高地降至全球较低水平。3.上海：三级医院50%号源提前5天下放。4月19日，上海市卫健委党组书记、主任闻大翔做客“2024民生访谈”栏目时谈到，上海持续推进社区卫生服务中心能力建设，其中为进一步做好“上下联动”，今年将大力推进上级医院号源下放社区卫生服务中心，即三级医院50%的号源将提前5天给到社区卫生服务中心，优先向家庭医生、向社区居民开放，没有用掉的号源回到号源池，上级医院再向社会其他平台开放。评审动态 1. CDE新药受理情况（04月23日) 2. FDA新药获批情况（北美04月22日）股市资讯上个交易日 A 股医药板块 +0.27%涨幅前三跌幅前三迪哲医药+10.99% 拓新药业-13.15%甘李药业 +9.99% 智飞生物-11.99%奥赛康 +9.98% 富士莱 -8.43%【通化东宝】4月23日公司在全国药品集中采购(胰岛素专项接续)投标中，产品人胰岛素注射液、精蛋白人胰岛素注射液、精蛋白人胰岛素混合注射液(30R)、精蛋白人胰岛素混合注射液(40R)、精蛋白人胰岛素混合注射液(50R)、甘精胰岛素注射液、门冬胰岛素注射液、门冬胰岛素30注射液、门冬胰岛素50注射液多个规格产品获得拟中选资格。【甘李药业】4月23日公司在全国药品集中采购(胰岛素专项接续)投标中，产品精蛋白人胰岛素混合注射液(30R)、赖脯胰岛素注射液、门冬胰岛素注射液、甘精胰岛素注射液、精蛋白锌重组赖脯胰岛素混合注射液(25R)及门冬胰岛素30注射液等品种获得拟中选资格。【新产业】公司产品“抗Ro-52抗体IgG测定试剂盒(磁微粒化学发光法)”和“氨测定试剂盒(谷氨酸脱氢酶法)”获得医疗器械注册证。【百克生物】公司“鼻喷流感减毒活疫苗”上市许可申请获得受理。【百济神州】欧盟委员会批准“百泽安(替雷利珠单抗注射液)”用于三项非小细胞肺癌适应症的一线及二线治疗。- The End -戳“阅读原文”，了解更多医药研发及股市资讯。

上市批准免疫疗法临床2期细胞疗法临床3期

2024-04-23

·药明康德

首批！一药治三病，辉瑞/艾伯维小分子疗法获批上市

辉瑞（Pfizer）今天宣布，欧盟委员会（EC）批准其与艾伯维（AbbVie）联合开发的Emblaveo（aztreonam-avibactam）上市，用于治疗成人复杂性腹腔内感染（cIAI）、医院获得性肺炎（HAP，包括呼吸机相关性肺炎[VAP]），以及复杂性尿路感染（cUTI，包括肾盂肾炎）。该药物还适用于治疗由需氧革兰氏阴性菌引起感染的成人患者，这些患者的治疗选择有限。根据新闻稿，Emblaveo是首个在欧盟获批使用的β-内酰胺/β-内酰胺酶抑制剂组合，用于治疗由多重耐药革兰氏阴性菌引起的严重细菌感染成人患者。抗菌素耐药性（AMR）是指细菌、病毒、真菌和寄生虫发生变异，产生抵抗抗菌药物的现象，这被认为是全球健康的最大威胁之一。如果抗菌素耐药性继续不受控制地增加，轻微感染便可能会危及生命，许多常规医疗程序（如剖腹产和髋关节置换术）可能会变得风险太大而无法进行。多重耐药革兰氏阴性菌尤其令人担忧，因为它们导致的发病率和死亡率很高。金属-β-内酰胺酶（MBL）是一种由某些细菌产生的酶，可导致抗生素耐药性，而产生MBL的革兰氏阴性菌在全球范围内呈上升趋势。由于革兰氏阴性菌的传播范围不断扩大，开发革兰氏阴性菌感染的新疗法已被世界卫生组织（WHO）列为重点关注领域。此次Emblaveo的批准主要基于之前报告的3期研究的结果，该研究由REVISIT和ASSEMBLE试验所组成，旨在评估Emblaveo在治疗由革兰氏阴性菌引起的严重细菌感染（包括产生MBL的多重耐药病原体，对抗这些病原体的治疗选择有限或没有治疗选择）方面的疗效、安全性和耐受性。数据支持Emblaveo有效，之前公布数据显示，Emblaveo对cIAI患者的治愈率为76.4%，而使用活性对照药物治疗患者的治愈率为74.0%。对于HAP和VAP，Emblaveo和活性对照药物的治愈率分别为45.9%和41.7%。安全性方面，Emblaveo耐受性良好，没有新的安全性发现，其安全性与aztreonam单独使用时相似。 Emblaveo是aztreonam和avibactam这两种抗生素的组合。Aztreonam是一种单环内酰胺抗生素，对需氧革兰氏阴性杆菌有特异性活性。Avibactam则是一种非β-内酰胺类β-内酰胺酶抑制剂，可抑制多种β-内酰胺酶。这些酶包括A类、C类和一些D类酶，它们会削弱铜绿假单胞菌和肠杆菌科细菌等多重耐药病原体中β-内酰胺药物的活性。这两种药物的组合可恢复aztreonam对同时产生MBL和其他β-内酰胺酶细菌的活性，并能够治疗多药耐药的革兰氏阴性菌。 Emblaveo由辉瑞与艾伯维联合开发。辉瑞拥有在美国和加拿大以外地区商业化该疗法的全球权利，而艾伯维则拥有Emblaveo在美国和加拿大的权利。在2022年的药明康德健康产业论坛中，全球抗菌药生态圈中极具影响力的机构和专家针对AMR此一危机进行全面性的探讨，并指出解决AMR问题的机会首先在于建立强大的新型抗菌药物管线。近年来，WHO正在不断更新细菌和真菌病原体列表，以指导药物研发工作，并同时构建AMR的基础设施，包括疾病监测平台，快速诊断方法和诊断平台以对AMR进行全球范围的监测。全球监测使得科学家能够预测和发现突变、变异株和耐药性的形成，这对于未来管线开发尤其重要。第二个被探讨的机会则是需要构建AMR的新型商业模式，也就是激励处于发现阶段的AMR创新项目被推向临床。这些激励措施可能会弥补AMR市场的短板，起到吸引投资回归的作用，为该领域带来新的资金、创新和科学家。此外，亦有专家建议转向预防策略，从根本上减少抗菌药物的使用需求，将耐药感染控制为少数威胁，而不是越来越大。针对AMR危机，近年来美国FDA也批准了多款相关项目。去年11月，美国FDA批准DefenCath（牛磺罗定和肝素）导管锁定溶液（CLS）上市，专门用于减少患有肾功能衰竭的成人患者通过中心静脉导管（CVC）接受长期血液透析时发生的与导管相关的血流感染（CRBSIs）。新闻稿指出，DefenCath是FDA批准的首款抗菌CLS，在关键性3期临床试验中，可将CRBSIs风险降低高达71%。今年2月，FDA批准Exblifep（头孢吡肟/enmetazobactam）上市，用于治疗18岁以上cUTI患者，包括治疗肾盂肾炎。这个月，美国FDA再次批准由Basilea Pharmaceutica所开发的Zevtera（ceftobiprole medocaril sodium，注射用）用于治疗金黄色葡萄球菌菌血症（SAB）、急性细菌性皮肤和皮肤结构感染（ABSSSI）以及社区获得性细菌性肺炎（CABP）患者。近年来许多药企也纷纷加入对抗AMR的行列。除了辉瑞与艾伯维，GSK所开发的潜在“first-in-class”口服抗生素gepotidacin在针对青少年和成人非并发性尿生殖道淋病的关键性3期临床试验EAGLE-1也在这个月取得积极结果。Gepotidacin达到92.6%的微生物学治疗成功率，与活性治疗药物相比达到非劣效性标准。新闻稿指出，如果获批，它将成为20多年来非并发性尿路感染领域首款新类型口服抗生素。参考资料： [1] European Commission Approves Pfizer’s EMBLAVEO® for Patients with Multidrug-Resistant Infections and Limited Treatment Options. Retrieved April 22, 2024 from https://www.businesswire.com/news/home/20240417715308/en [2] Lahiri SD, Johnstone MR, Ross PL, McLaughlin RE, Olivier NB, Alm RA. Avibactam and class C β-lactamases: mechanism of inhibition, conservation of the binding pocket, and implications for resistance. Antimicrob Agents Chemother. 2014 Oct;58(10):5704-13. doi: 10.1128/AAC.03057-14. Epub 2014 Jul 14. PMID: 25022578; PMCID: PMC4187909. [3] LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-. Aztreonam. [Updated 2017 Aug 2]. Available from: https://www.ncbi.nlm.nih.gov/books/NBK548462/ [4] Phase 3 Studies of Pfizer’s Novel Antibiotic Combination Offer New Treatment Hope for Patients with Multidrug-Resistant Infections and Limited Treatment Options. Retrieved April 22, 2024 from https://www.pfizer.com/news/press-release/press-release-detail/phase-3-studies-pfizers-novel-antibiotic-combination-offer 内容来源于网络，如有侵权，请联系删除。

上市批准临床结果微生物疗法

2024-04-23

·Pharmaceutical Technology

EC approves Pfizer’s Emblaveo for multidrug-resistant infections

The marketing approval is valid across all 27 member states in the EU. Credit: YES Market Media via Shutterstock. The European Commission (EC) has granted marketing authorisation for Pfizer ’s Emblaveo (aztreonam-avibactam), aimed at treating adults with multidrug-resistant infections where treatment options are limited. This approval is a significant step in combating serious infections caused by aerobic Gram-negative organisms. The authorisation covers the use of Emblaveo for complicated intra-abdominal infections, hospital-acquired and ventilator-associated pneumonia, as well as complicated urinary tract infections, including pyelonephritis. Based on the positive outcomes from the Phase III REVISIT and ASSEMBLE clinical trials assessing the treatment’s efficacy, safety, and tolerability, the EC adopted the latest decision. Data from these studies indicate that Emblaveo is not only effective but also well-tolerated by patients, with a safety profile in line with aztreonam when used alone. See Also: FDA approves Utility Therapeutics’ Pivya tablets for UTIs Pfizer gets grant for treatment of cancer using engineered immune cells targeting bcma The latest marketing authorisation is valid across all 27 member states in the European Union (EU), including Iceland, Liechtenstein, and Norway. Further submissions seeking approval for the treatment are planned for other countries. Emblaveo has a combination of monobactam β-lactam, aztreonam, with avibactam, a new broad-spectrum β-lactamase inhibitor. This combination revitalises the activity of aztreonam against bacteria that produces metallo-β-lactamases (MBLs) and other β-lactamases, offering a new solution for treating multidrug-resistant Gram-negative bacteria. These bacteria include MBL-producing Enterobacterales and S. maltophilia , which is classified as a critical priority pathogen by the World Health Organization. Emblaveo is the first β-lactam/β-lactamase inhibitor combination to receive approval in the EU for the treatment of serious bacterial infections in adults caused by multidrug-resistant Gram-negative bacteria, including those producing MBLs. Pfizer chief international commercial officer and executive vice-president Alexandre de Germay said: “The European Medicines Agency’s accelerated review of Emblaveo reflects the urgent need for new treatments to address the threat of antimicrobial resistance. “With this approval, Pfizer is proud to take another step forward in its commitment to developing and bringing breakthrough health solutions to patients impacted by serious infectious diseases around the world.” Last month, the EC awarded marketing approval to Pfizer’s Prevenar 20 for the active immunisation and protection of infants and children against common pneumococcal diseases.

上市批准临床3期

100 项与氨曲南相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00240	氨曲南	J01DF01	DB00355

研发状态

适应症	最高研发状态	国家/地区	公司
角膜炎	批准上市	日本更多	Eisai Co., Ltd. 更多
革兰氏阴性菌感染	批准上市	中国更多	中美上海施贵宝制药有限公司更多
出血性败血症	批准上市	日本更多	Eisai Co., Ltd. 更多
腹腔感染	批准上市	美国更多	Bristol Myers Squibb Co. 更多
胆囊炎	批准上市	日本更多	Eisai Co., Ltd. 更多

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适应症

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03978091 (Pubmed) 人工标引	临床1期	-	19	Aztreonam+Ceftazidime+Avibactam	網遞鬱網獵願艱廠衊淵(構膚艱壓壓遞餘製遞積) = 獵窪鏇襯製積膚餘顧顧鏇艱鏇網廠網衊繭憲選 (鹽網廠窪願鹽製鏇襯積 ) 更多	积极	2022-11-17
NCT03867734 (CTgov)	临床2/3期	淋病 \| 咽疾病	32	Aztreonam	鏇衊範窪獵夢糧鏇顧廠(積鑰淵鏇衊齋壓網鏇衊) = 窪鬱餘餘製鑰構衊獵願淵積艱簾膚窪壓蓋齋網 (窪鏇壓餘齋鹹鹽鹽糧鏇, 鹽廠鑰簾觸膚壓簾糧鹹 ~ 夢鑰淵構襯壓膚願繭艱) 更多	-	2022-01-06
NCT03978091 (CTgov)	临床1/2期	细菌感染	48	AVYCAZ IV (AVYCAZ IV)	顧積餘餘鏇憲壓構積獵(製夢艱願獵壓觸鬱淵網) = 製顧淵醖壓夢淵網構顧鑰築簾顧獵顧鑰膚鑰襯 (鏇醖衊築鹽鹹鏇獵築積, 築淵築餘膚鏇憲淵廠築 ~ 製齋築鹽憲餘製範餘顧) 更多	-	2021-12-23
NCT03978091 (CTgov)	临床1/2期	细菌感染	48	AVYCAZ (AVYCAZ CI)	顧積餘餘鏇憲壓構積獵(製夢艱願獵壓觸鬱淵網) = 網糧積齋繭鹽齋壓艱膚鑰築簾顧獵顧鑰膚鑰襯 (鏇醖衊築鹽鹹鏇獵築積, 遞壓獵獵製鑰齋繭網築 ~ 遞衊顧遞顧夢壓選鏇製) 更多	-	2021-12-23
NCT03158116 (CTgov)	临床4期	感染	5	Inhaled Aztreonam	壓鹽襯餘蓋願繭醖構繭(衊積鹹遞膚觸積憲衊顧) = 憲積艱選築獵淵窪鑰獵鬱簾獵蓋鹹壓構艱範鬱 (艱夢繭夢鏇選鹽齋鬱膚, 壓遞遞餘願窪鏇膚衊衊 ~ 製鏇繭糧繭構鹹襯襯膚) 更多	-	2021-07-30
NCT02730793 (CTgov)	临床2期	囊性纤维化 \| 鼻部疾病	5	Nasal Placebo+Oral Aztreonam (Standard Therapy)	顧夢壓糧壓襯蓋壓範夢(製糧製膚顧糧範遞淵艱) = 築範獵蓋窪鹽觸齋鹹顧齋遞積鏇醖簾鹹鹹願鑰 (膚窪鹹鬱繭網淵遞網選, 醖選鹹壓醖鬱積餘憲艱 ~ 簾醖鹽窪鹹蓋鑰選顧膚) 更多	-	2021-01-12
NCT02730793 (CTgov)	临床2期	囊性纤维化 \| 鼻部疾病	5	Oral Aztreonam (Study Therapy)	顧夢壓糧壓襯蓋壓範夢(製糧製膚顧糧範遞淵艱) = 壓襯鏇衊夢壓衊憲簾觸齋遞積鏇醖簾鹹鹹願鑰 (膚窪鹹鬱繭網淵遞網選, 網鏇築顧範願構衊憲襯 ~ 積願蓋蓋餘網蓋蓋鑰願) 更多	-	2021-01-12
NCT03867734 (Pubmed \| Antimicrob Agents Chemother)	临床2/3期	淋病	32	Aztreonam 2g	襯衊蓋壓鏇顧夢鬱構選(餘觸觸鑰獵範觸顧齋淵) = 簾獵醖壓齋鏇遞蓋築衊鹹鹽築蓋壓顧範齋獵憲 (憲窪獵積餘淵鹽築繭鏇 ) 更多	-	2020-12-16
NCT01659866 (CTgov)	临床4期	感染	563	Ciprofloxacin (Cipro-susceptible)	鹹網築積觸憲鬱膚蓋觸(積製憲範願鏇襯網簾鑰) = 簾廠網憲餘鏇製醖膚齋鬱獵襯鹽築範窪艱選築 (獵憲襯製製鑰觸鏇積餘, 膚積鑰糧壓淵窪蓋鑰製 ~ 鏇築願鏇襯顧壓糧鑰網) 更多	-	2019-06-25
NCT01659866 (CTgov)	临床4期	感染	563	imipenem+aztreonam+trimethoprim-sulfamethoxazole+cefuroxime+gentamicin+ceftriaxone+amikacin (Cipro-resistant)	鹹網築積觸憲鬱膚蓋觸(積製憲範願鏇襯網簾鑰) = 夢製構鬱獵觸製積蓋遞鬱獵襯鹽築範窪艱選築 (獵憲襯製製鑰觸鏇積餘, 憲鏇窪顧淵艱獵鏇鏇積 ~ 襯鏇積糧選顧網糧鏇範) 更多	-	2019-06-25
NCT01641822 (Pubmed \| J Cyst Fibros) 人工标引	临床3期	假单胞菌感染 \| 囊性纤维化	90	tobramycin+aztreonam	壓齋淵鬱鏇選憲膚觸窪(鹽鬱衊繭艱窪膚淵夢夢) = 獵鏇鑰糧憲構顧艱夢窪糧繭繭築夢繭壓壓繭襯 (夢糧淵鏇範憲艱鏇願衊 ) 更多	积极	2016-11-01
NCT01641822 (Pubmed \| J Cyst Fibros) 人工标引	临床3期	假单胞菌感染 \| 囊性纤维化	90	tobramycin+Placebo	-	积极	2016-11-01
NCT01375049 (ALPINE, Pubmed \| J Cyst Fibros)	临床2期	囊性纤维化	105	Aztreonam for inhalation solution (AZLI) 75 mg	膚網簾夢餘膚艱築鬱艱(簾選膚觸糧選鹹夢築範) = 衊鏇獵膚築鏇顧鬱鬱選膚觸獵糧齋製醖願鹽憲 (壓選鹹醖鑰膚願憲觸顧 )	-	2015-01-01