硫酸甲苯磺酸头孢德罗(Cefiderocol Sulfate Tosylate) - 药物靶点：PBPs_在研适应症：复杂的尿路感染，感染，革兰氏阴性菌感染_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Cefiderocol、Cefiderocol sulfate tosilate、Cefiderocol sulfate tosylate (USAN)

+ [19]

靶点

PBPs

作用方式

抑制剂

作用机制

PBPs抑制剂(细菌青霉素结合蛋白家族抑制剂)

治疗领域

感染呼吸系统疾病泌尿生殖系统疾病+ [1]

在研适应症

复杂的尿路感染感染革兰氏阴性菌感染+ [12]

非在研适应症

急性肾盂肾炎复杂腹腔感染脓尿

原研机构

Shionogi & Co., Ltd.

在研机构

Shionogi, Inc.

Shionogi & Co., Ltd.盐野义有限公司

+ [3]

非在研机构

Qualicaps Netherlands BV

权益机构

Jeil Pharmaceutical Co., Ltd.

Global Antibiotic Research & Development Partnership

Clinigen Ltd.

+ [5]

最高研发阶段批准上市

首次获批日期

美国 (2019-11-14),

肾盂肾炎泌尿道感染

最高研发阶段(中国)批准上市

特殊审评快速通道 (美国)、孤儿药 (日本)

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结构/序列

分子式C30H34ClN7O10S2

InChIKeyDBPPRLRVDVJOCL-FQRUVTKNSA-N

CAS号1225208-94-5

关联

27

项与硫酸甲苯磺酸头孢德罗相关的临床试验

CTIS2024-516232-10-00

/ Not yet recruiting临床4期IIT

Defining Antibiotic Levels in Intensive care patients (DALI-2) protocol - A multi-national pharmacokinetic/pharmacodynamic cohort study to determine whether contemporary antibiotic dosing for critically ill patients achieves therapeutic exposures.

开始日期2025-12-01

申办/合作机构

Centre Hospitalier Universitaire de Nimes

CTIS2024-518220-72-00

/ Recruiting临床1期IIT

Plasma and intraperitoneal pharmacokinetics of cefiderocol in peritoneal dialysis patients

开始日期2025-05-20

申办/合作机构

Medical University of Vienna

NCT07004049

/ Recruiting临床4期IIT

TREAT-GNB [CR-GNB]

TREAT-GNB is an innovative trial to expedite the evaluation of various antibiotic choices and treatment strategies for severe multidrug-resistant Gram-negative bacterial infections, specifically bloodstream and lower respiratory tract infections. This approach combines platform trial elements with adaptive clinical designs to streamline the evaluation of various treatment options and optimise resource utilisation. The overall aim of the TREAT-GNB platform trial is to identify interventions that improve survival in patients with severe infections due to Gram-negative bacteria.
In the CR-GNB silo of TREAT-GNB, the primary objective is to quantify the effect on all-cause mortality at 28 days of a range of interventions in patients with bloodstream infections, ventilator-associated pneumonia, and hospital-acquired pneumonia caused by CR-GNB.

开始日期2025-04-21

申办/合作机构

National University of Singapore

[+1]

100 项与硫酸甲苯磺酸头孢德罗相关的临床结果

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100 项与硫酸甲苯磺酸头孢德罗相关的转化医学

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100 项与硫酸甲苯磺酸头孢德罗相关的专利（医药）

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783

项与硫酸甲苯磺酸头孢德罗相关的文献（医药）

2026-02-01·INTERNATIONAL JOURNAL OF ANTIMICROBIAL AGENTS

EnvZ mutation–driven downregulation of catecholate siderophore receptors and concurrent TonB complex repression confer cefiderocol resistance in a KPC-producing ST11-KL64 hypervirulent Klebsiella pneumoniae

Article

作者: Zhuo, Xianxia ; Cao, Bin ; Song, Rongrong ; Wang, Chunhui ; Zhao, Jiankang ; Pu, Danni

OBJECTIVES:

Cefiderocol is an ultimate antibiotic option for Carbapenem-resistant hypervirulent Klebsiella pneumoniae (CR-hvKP). While resistance often involves metallo-β-lactamases, mechanisms in KPC-producing strains are unclear. This study aimed to elucidate novel cefiderocol resistance mechanisms in a clinical KPC-producing ST11-KL64 CR-hvKP isolate.

METHODS:

Cefiderocol-resistant mutants were generated through in vitro experimental evolution. Resistance-associated mutations were identified by whole-genome sequencing. Transcriptomic and proteomic analyses were performed to characterize global regulatory changes and were validated by qRT-PCR and targeted genetic manipulation. Additional tests examined siderophore production, intracellular iron levels, bacterial fitness, oxidative stress tolerance, and macrophage survival.

RESULTS:

All high-level cefiderocol-resistant mutants acquired a gain-of-function mutation in the sensor kinase EnvZ (V145G). Integrated transcriptomic and proteomic analyses showed that the envZ mutation drove marked downregulation of catecholate siderophore receptors (cirA and fepA), impairing cefiderocol uptake. In parallel, the TonB-ExbB-ExbD energy transduction complex was independently and stably downregulated, synergistically contributing to resistance. Notably, envZ mutation-associated repression of the enterobactin biosynthesis gene entB paradoxically increased cefiderocol susceptibility, indicating a regulatory trade-off. Resistant mutants exhibited reduced siderophore production, impaired intracellular iron accumulation, and significant fitness costs, including attenuated growth, reduced oxidative stress tolerance, and decreased survival within macrophages.

CONCLUSIONS:

In conclusion, this work uncovers a novel cefiderocol resistance mechanism in KPC-producing ST11-KL64 CR-hvKp, initiated by the envZ mutation, which causes the downregulation of catecholate siderophore receptors. This receptor repression, combined with the stable downregulation of the TonB-ExbB-ExbD energy complex, severely impairs cefiderocol's "Trojan horse" active uptake. This resistance mechanism is accompanied by a fitness trade-off, providing critical insights into the evolution of these superbugs.

2026-02-01·DIAGNOSTIC MICROBIOLOGY AND INFECTIOUS DISEASE

Rapid detection of susceptibility to the ceftazidime-avibactam/aztreonam combination and cefiderocol in MBL-producing Enterobacterales by MALDI-TOF MS and turbidimetry

Article

作者: Torres, Ignacio ; Camacho, Jorge ; Colomina, Javier ; Cano, Sofía ; Belizón, Blanca ; Sánchez, David ; Navarro, David ; Poirel, Laurent ; de Michelena, Paula

INTRODUCTION:

Metallo-β-lactamase (MBL)-producing Enterobacterales pose a critical therapeutic challenge due to limited treatment options and high associated mortality. Aztreonam (ATM) combined with avibactam (AVI) and cefiderocol (FDC) are the recommended treatment strategies; however, standard methods for assessing aztreonam/ceftazidime-avibactam (ATM-CZA) synergy and FDC susceptibility are time-consuming and not widely implemented. In this context, the objective of this study was to evaluate whether matrix-assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF MS) and turbidimetry could serve as rapid, reliable tools for assessing susceptibility to ATM-CZA and FDC in MBL-producing Enterobacterales.

METHODS:

Thirty-eight clinical MBL-producing isolates were tested. Potential ATM-CZA synergy and FDC susceptibility were assessed using a broth disk elution protocol adapted for MALDI-TOF MS and turbidimetric analysis. Results were compared against reference methods: cross-gradient strips for synergy and EUCAST-standardized techniques for FDC susceptibility. Agreement, sensitivity, specificity, and ROC analyses were performed.

RESULTS:

MALDI-TOF MS achieved 100 % categorical agreement (CA) with the reference method for synergy detection after eight hours of incubation using standard inoculum. FDC susceptibility was correctly identified with 87 % CA within six to eight hours. Turbidimetry also showed strong performance, with up to 93.3 % CA for susceptibility to the ATM-CZA combination and 91.3 % for FDC, demonstrating statistically significant discrimination in absorbance values at six to eight hours.

CONCLUSION:

MALDI-TOF MS and turbidimetry offer accurate and rapid alternatives for the phenotypic detection of susceptibility to the ATM-CZA combination and FDC in MBL-producing Enterobacterales. These methods may enhance early antimicrobial decision-making in clinical microbiology laboratories.

2026-02-01·DIAGNOSTIC MICROBIOLOGY AND INFECTIOUS DISEASE

Pseudomonas guariconensis Necrotizing soft tissue infection, Denmark

Article

作者: Nielsen, Allan Evald Væver ; Calum, Henrik Pierre ; Monrad, Nina Elisabeth Pontoppidan ; Ehlers-Hansen, Jacob ; Soltau, Sofus Rønne

PATIENT AND METHODS:

A 72-year-old man presented to the emergency department with a 3-day history of fever, pain in the right leg/foot and general malaise. He was diagnosed with NSTI, empirical meropenem and clindamycin was started, and surgery was quickly performed with removal of all dead skin and subcutaneous tissue. All fasciae were intact.

RESULTS:

Blood cultures and tissue samples showed growth of Pseudomonas guariconensis, which a literature review revealed to be highly suspicious of meropenem resistance. This prompted quick change of antibiotics, first with ciprofloxacin and metronidazole added and then change of meropenem to cefiderocol. Susceptibility tests on both blood and tissue samples revealed resistance to meropenem (along with resistance to many other antibiotics). The patient improved, was changed to ceftazidim and ciprofloxacin and recovered fully from the infection.

CONCLUSIONS:

Since clindamycin has no effect on any Pseudomonas species and since Pseudomonas guariconensis has been resistant to meropenem in all reported cases, clinicians and microbiologists should treat these patients with extreme care.

88

项与硫酸甲苯磺酸头孢德罗相关的新闻（医药）

2026-01-10

·医脉通

盐野义新型抗菌药物头孢德罗（斐铁嘉）正式获国家药品监督管理局批准上市

盐野义有限公司（以下简称“盐野义”）宣布新型抗菌药物头孢德罗（Cefiderocol）（商品名称：斐铁嘉/ Fetroja，通用名称：注射用硫酸甲苯磺酸头孢德罗，以下简称“头孢德罗”）已于2026年1月5日正式获得国家药品监督管理局（NMPA）批准上市，用于治疗革兰阴性菌引起的复杂性尿路感染（cUTI），包括肾盂肾炎。头孢德罗为新型铁载体头孢菌素类抗菌药物，凭借其独特的作用机制，为中国患者提供新的治疗选择。与此同时，头孢德罗针对耐碳青霉烯类革兰阴性菌引起的感染 (CR) 的临床试验正在稳步推进中。目前，头孢德罗已获得欧盟、英国（商品名称：Fetcroja）、美国、日本、韩国、中国台湾（商品名称：Fetroja）等全球多个国家和地区的上市许可（不同国家或地区的获批适应症请以当地药品监管部门发布的公告为准）。本次获批是基于针对复杂性尿路感染患者的一项境外国际多中心临床试验（APEKs-cUTI）[1]和一项中国多中心、随机、双盲临床试验的结果。APEKs-cUTI试验结果表明头孢德罗在治愈评估访视（TOC）的微生物学清除和临床应答组成的综合应答率方面，达到了预先设定的相对于亚胺培南/西司他丁（IPM/CS）的非劣效性标准，此外组间差异（Cefiderocol减去IPM/CS）的95% CI下限超过零。头孢德罗耐受性良好，未发现非预期的安全性问题，证明头孢德罗是一种安全有效的治疗复杂性尿路感染的药物。中国临床试验与APEKs-cUTI设计相似，该研究以IPM/CS为对照，共有150例复杂性尿路感染受试者被随机（2:1）分配给予头孢德罗和IPM/CS, 验证头孢德罗的有效性和安全性。这项中国cUTI临床试验达到了主要疗效终点，即头孢德罗组与IPM/CS组相比，在TOC时综合应答率（微生物学清除且临床应答）的组间差异，与APEKs-cUTI试验的非劣效性一致；在中国cUTI人群中耐受性良好，未观察到评估为与研究药物有关的非预期事件和新的安全性风险。头孢德罗治疗中国成人患者由革兰阴性菌引起的cUTI（包括肾盂肾炎）的疗效及安全性良好，且与既往全球APEKS-cUTI试验结果整体一致。小结抗微生物药物耐药性（AMR）被称为“无声的流行病”，是目前人类面临的全球性公共卫生威胁之一，也是亟待解决的全球性重要课题。若不采取行动，到2050年抗菌药物耐药性每年或导致千万人死亡[2]，新型抗菌药物的研发与应用迫在眉睫。此次新药的成功获批为中国抗感染治疗提供了创新解决方案。接下来，盐野义将加快推进药品上市进程，持续深化创新药物研发，为守护人类健康福祉贡献力量，同时助力中国医疗水平的持续提升。关于头孢德罗（Cefiderocol）头孢德罗（Cefiderocol）是一种新型铁载体头孢菌素类抗菌药物，通过铁载体（铁离子结合性有机化合物）发挥作用，具有穿透革兰阴性菌细胞外膜的新机制。头孢德罗不仅可以通过膜孔蛋白通道被动转运进入细菌，还可以与铁离子相结合形成复合物，在细菌利用自身分泌铁载体摄入必须营养素（铁）的同时，主动运输至细菌体内。在这些机制的作用下，头孢德罗在细菌周质间隙中达到高浓度，通过与青霉素结合蛋白（PBP）结合，抑制细菌细胞壁的合成，从而发挥抗菌活性。头孢德罗已收录至世界卫生组织（WHO）的《基本药物标准清单》[3]，目前正通过与全球抗生素研究与发展伙伴关系（GARDP）和克林顿健康发展组织（CHAI）的三方联合协议[4]推进准备工作，从而改善更多有需求的中低收入、中高收入国家患者的药物获取途径。声明本新闻稿包含的信息是基于当前可获得信息下的预期及假设，而相关假设可能受风险和不确定性影响，导致实际结果与声明内容存在重大差异。盐野义明确声明，无论基于新信息、未来事件或其他原因，均无义务对新闻稿中前瞻性表述进行更新或修正。本材料旨在传递前沿信息，不构成任何药物或治疗方案的推荐或宣传。如您有药物或治疗方面的问题，请遵从医疗卫生专业人士的意见与指导。参考文献： [1]注射用头孢德罗说明书(2026年1月5日版) [2] O'Neill, J. Tackling Drug-Resistant Infections Globally: Final Report and Recommendations. Review on Antimicrobial Resistance, 2016, https://www.amrreview.org/sites/default/files/160525_Final%20paper_with%20cover.pdf. [3]World Health Organization. WHO Model List of Essential Medicines - 23rd List, 2023, https://www.who.int/publications/i/item/WHO-MHP-HPS-EML-2023.02. WHO Reference No.: WHO/MHP/HPS/EML/2023.02. [4] https://www.shionogi.com/global/en/news/2022/06/e220615.html 审校：Lya、Atai 排版：Atai 执行：Atai 本平台旨在为医疗卫生专业人士传递更多医学信息。本平台发布的内容，不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议。如该等信息被用于了解医学信息以外的目的，本平台不承担相关责任。本平台对发布的内容，并不代表同意其描述和观点。若涉及版权问题，烦请权利人与我们联系，我们将尽快处理。

2026-01-08

·药品圈

0108 II 59个品规新获批准（含生1类、化1类等）！

前言： 2022年11月1日起，行政相对人可登录网上办事大厅的法定代表人空间查看电子证照，按照法人空间内相关提示自行打印。今日（1月8日），NMPA官网发布药品批准证明文件待领取信息发布（共计60个），59个品规新获批准（2个化药2.2类、1个治疗用生物制品3.2类、1个治疗用生物制品1类、1个化药5.1类、1个化药1类、1个治疗用生物制品3.4类、23个化药3类和29个化药4类）、1个新增适应症获批。我们一起看看都是哪些品规获批吧！值得关注的是品种：（1）瑞拉芙普α注射液 (治疗用生物制品1类，苏州盛迪亚生物医药有限公司）瑞拉芙普α注射液是公司自主研发并具有知识产权的抗PD-L1/TGF-βRII 双功能融合蛋白，本品能够通过特异性阻断PD-1/PD-L1的相互作用，同时中和肿瘤微环境中的TGF-β，发挥抗肿瘤作用。经查询，国内外尚无同类产品获批上市。截至目前，瑞拉芙普α注射液相关项目累计研发投入约71,130万元。（2）注射用硫酸甲苯磺酸头孢德罗（化药5.1类、盐野义有限公司）头孢德罗（cefiderocol）是一种新型抗生素，可用于治疗严重革兰氏阴性细菌感染。Fetroja（cefiderocol）于2019年获得美国FDA的批准，用于18岁或以上的患者，治疗复杂性尿路感染（cUTI），包括由以下易感革兰氏阴性微生物引起的肾脏感染：大肠杆菌、肺炎克雷伯菌、奇异变形杆菌、铜绿假单胞菌和阴沟肠杆菌复合物。Fetroja的安全性和有效性在一项包含448名cUTI患者的研究中得到验证。接受Fetroja治疗的患者中，72.6%在完成治疗7天后症状消失并且细菌得到清除，而使用其它抗生素的对照组中这一数值为54.6%。值得一提的是，头孢德罗被世界卫生组织（WHO）列入儿科药物优化（PADO）重点名单。因为它对WHO细菌重点病原体清单中的多种病原体有效，具有良好的耐药性和交叉耐药性，并且考虑到涉及儿童的临床试验正在进行中。（3）普乐司兰钠注射液（化药1类，维亚臻生物技术（苏州）有限公司）普乐司兰钠注射液正式在国内获批，用于在饮食控制基础上降低家族性乳糜微粒血症综合征（FCS）成人患者的甘油三酯水平。该药是全球首个作用于创新靶点APOC3（载脂蛋白C-III） mRNA的小干扰RNA药物。普乐司兰钠注射液是维亚臻的大股东 Arrowhead Pharmaceuticals, Inc. （NASDAQ: ARWR）同类首创的RNA干扰治疗候选药物，旨在减少载脂蛋白 C-III （APOC3）的产生，在大中华区，它是家族性乳糜微粒血症综合征（FCS）和严重高甘油三酯血症（SHTG）的潜在治疗方案。 2022年4月25日，维亚臻自Arrowhead获得在大中华区开发和商业化普乐司兰钠注射液等四种在研心血管代谢候选药物的权利。普乐司兰钠注射液用于治疗FCS患者也已获得中国NMPA的突破性疗法认定和优先审评资格。 2025年8月25日 – 维亚臻与赛诺菲宣布就在研药物普乐司兰钠注射液（Plozasiran）资产购买协议完成交割。根据协议，赛诺菲已获得在大中华区开发和商业化普乐司兰钠注射液的权利。

上市批准信使RNA临床3期

2026-01-08

·shionogi.com

Approval for Cefiderocol in China

OSAKA, Japan, January 8, 2026 - Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter "Shionogi") announced that its group company, Shionogi China Co., Ltd. (Head Office: Shanghai, China; Chairman: Hirofumi Nagatome), has received approval from the National Medical Products Administration (NMPA) of China for cefiderocol (generic name: Cefiderocol Sulfate Tosylate for Injection; hereinafter “cefiderocol”) for the treatment of complicated urinary tract infections including pyelonephritis caused by Gram-negative bacteria. This approval is based on positive results from an international multicenter clinical study¹ and a randomized, double-blind, multicenter study² conducted in China. In both studies, which aimed to verify non-inferiority to the comparator drug, cefiderocol demonstrated non-inferiority to imipenem/cilastatin and achieved the primary endpoint. Furthermore, no new safety concerns were identified, and cefiderocol was well tolerated. Antimicrobial resistance (AMR) occurs when bacteria develop resistance to antibiotics, making infections harder to treat. AMR is often referred to as a “silent pandemic” and is recognized as one of the most pressing global public health threats requiring urgent action3. In 2021, AMR was estimated to have caused 1.14 million deaths worldwide4. Without coordinated international efforts, it is projected that more than 39 million lives could be lost over the next 25 years5. Meanwhile, treatment options remain limited, making this an area of high unmet medical need. With this approval, cefiderocol is expected to provide a new treatment option for patients in mainland China suffering from difficult-to-treat complicated urinary tract infections. Shionogi has identified “Protecting people from the threat of infectious diseases” as a material issue and is committed to realizing total care for infectious diseases. We will continue to work toward delivering essential anti-infective treatments to patients worldwide as quickly as possible, contributing to global efforts to combat AMR. For more information on Shionogi’s initiatives against AMR, please visit. Clich here to learn more about our efforts to address antimicrobial resistance. About Cefiderocol Cefiderocol is an antibiotic that penetrates the outer membrane of Gram-negative bacteria, including multidrug-resistant strains, to exert its antibacterial activity. As of December 2025, cefiderocol is marketed in 27 countries and regions, including Japan, Europe, U.S., Taiwan and China. It is listed on the WHO Model List of Essential Medicines, demonstrating its continued importance in improving outcomes for patients with some of the most difficult-to-treat Gram-negative infections. Prior to this approval, the Hainan Provincial Medical Products Administration had authorized its clinical use in the Boao Lecheng International Medical Tourism Pilot Zone in China6. References 1. Press release: January 12, 2017 2. Chinese Clinical Trial Registry: Phase III clinical trial registration number CTR20223300 3. Antimicrobial Resistance Collaborators. Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. Lancet 2022; 399: 629–55. 4. GBD 2021 Antimicrobial Resistance Collaborators. Global burden of bacterial antimicrobial resistance 1990-2021: a systematic analysis with forecasts to 2050. Lancet. 2024 Sep 28;404(10459):1199-1226. doi: 10.1016/S0140-6736(24)01867-1. Epub 2024 Sep 16. PMID: 39299261. 5. Antimicrobial resistance (who.int) WHO. Antimicrobial resistance. Who.int. Published October 13, 2020. 6. Press release: August 5, 2024 Forward-Looking Statements This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise. For Further Information, Contact: SHIONOGI Website Inquiry Form: https://www.shionogi.com/global/en/contact.html

临床3期上市批准临床结果

100 项与硫酸甲苯磺酸头孢德罗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11013	硫酸甲苯磺酸头孢德罗	J01D	DB14879

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
复杂的尿路感染	韩国	Jeil Pharmaceutical Co., Ltd.	2025-02-18
感染	日本	Shionogi Pharma, Inc.	2023-11-30
医院获得性肺炎	美国	Shionogi, Inc.	2020-09-25
克雷伯菌感染	美国	Shionogi, Inc.	2020-09-25
呼吸机相关性肺炎	美国	Shionogi, Inc.	2020-09-25
沙雷菌感染	美国	Shionogi, Inc.	2020-09-25
革兰氏阴性菌感染	欧盟	Qualicaps Netherlands BV	2020-04-23
革兰氏阴性菌感染	冰岛	Qualicaps Netherlands BV	2020-04-23
革兰氏阴性菌感染	列支敦士登	Qualicaps Netherlands BV	2020-04-23
革兰氏阴性菌感染	挪威	Qualicaps Netherlands BV	2020-04-23
肾盂肾炎	美国	Shionogi, Inc.	2019-11-14
泌尿道感染	美国	Shionogi, Inc.	2019-11-14

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
医院获得性细菌性肺炎	临床3期	美国	Shionogi, Inc.	2017-10-24
医院获得性细菌性肺炎	临床3期	日本	Shionogi, Inc.	2017-10-24
医院获得性细菌性肺炎	临床3期	比利时	Shionogi, Inc.	2017-10-24
医院获得性细菌性肺炎	临床3期	加拿大	Shionogi, Inc.	2017-10-24
医院获得性细菌性肺炎	临床3期	捷克	Shionogi, Inc.	2017-10-24
医院获得性细菌性肺炎	临床3期	爱沙尼亚	Shionogi, Inc.	2017-10-24
医院获得性细菌性肺炎	临床3期	法国	Shionogi, Inc.	2017-10-24
医院获得性细菌性肺炎	临床3期	格鲁吉亚	Shionogi, Inc.	2017-10-24
医院获得性细菌性肺炎	临床3期	德国	Shionogi, Inc.	2017-10-24
医院获得性细菌性肺炎	临床3期	匈牙利	Shionogi, Inc.	2017-10-24

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临床结果

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分期

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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


NCT05789199 (PERSEUS study, Pubmed \| Eur J Clin Microbiol)	N/A	革兰氏阴性菌感染	261	Cefiderocol	衊淵遞衊觸艱窪齋鹽簾(淵齋衊鏇鏇鑰壓窪艱壓) = 範鬱繭範顧艱蓋鑰壓齋築鏇遞膚憲觸鹹餘願襯 (艱鏇餘夢蓋壓獵簾簾糧 ) 更多	积极	2025-03-25
NCT05789199 (PERSEUS study, Pubmed \| Eur J Clin Microbiol)	N/A	慢性肾病 Gram-negative bacteria	-	Cefiderocol (Stenotrophomonas maltophilia)	鏇觸鏇夢簾顧選壓鹽鏇(膚夢艱醖鬱鏇艱製鬱糧) = 膚獵構遞夢選觸憲餘築顧構糧廠願製醖糧衊壓 (醖鑰鏇鏇鏇膚選糧醖糧 )	积极	2025-03-24
				Cefiderocol (Burkholderia cepacia complex)	鏇觸鏇夢簾顧選壓鹽鏇(膚夢艱醖鬱鏇艱製鬱糧) = 餘鏇顧鹹餘蓋齋遞淵繭顧構糧廠願製醖糧衊壓 (醖鑰鏇鏇鏇膚選糧醖糧 )
NCT05395104 (CTgov)	临床1期	-	14	Cefiderocol+Midazolam	鹹製鬱鹹襯壓壓淵夢積(蓋壓網淵衊遞網鏇網顧) = 鏇範蓋憲醖願衊淵淵襯鹹構鏇願鬱鹹鏇憲鹽淵 (憲構鹽壓夢鹽餘餘願鑰, 45.3) 更多	-	2023-12-14
NCT03032380 (APEKS-NP, Pubmed \| Eur J Clin Microbiol) 人工标引	临床3期	医疗保健相关性肺炎	-	Linezolid+Cefiderocol	簾餘糧鑰製鏇鬱蓋鹽膚(壓鏇網範願獵餘繭醖廠) = 簾鏇蓋壓構窪蓋壓鑰構膚構蓋蓋顧壓願鏇襯襯 (齋憲蓋觸獵簾窪鬱繭鑰 ) 更多	非劣	2022-01-13
				Linezolid+meropenem	簾餘糧鑰製鏇鬱蓋鹽膚(壓鏇網範願獵餘繭醖廠) = 餘獵窪獵廠網繭選憲鏇膚構蓋蓋顧壓願鏇襯襯 (齋憲蓋觸獵簾窪鬱繭鑰 ) 更多
NCT02714595 (CREDIBLE-CR, Pubmed \| Lancet Infect Dis) 人工标引	临床3期	感染	152	cefiderocol	醖醖餘觸醖獵遞鬱鏇觸(衊鏇夢簾選築鹹窪範繭) = 願衊繭窪顧繭鑰繭範製選鑰鏇選願壓憲獵網顧 (醖餘窪鏇網構構範獵鹹, 23.2 ~ 65.5) 更多	相似	2021-02-01
				best available therapy	醖醖餘觸醖獵遞鬱鏇觸(衊鏇夢簾選築鹹窪範繭) = 餘蓋憲齋簾遞鹽構蓋簾選鑰鏇選願壓憲獵網顧 (醖餘窪鏇網構構範獵鹹, 17.7 ~ 71.1) 更多
NCT02321800 (APEKS-cUTI, Pubmed)	临床2期	复杂下尿路感染	371	Cefiderocol	選衊鏇夢獵願憲簾蓋獵(網鹽鹹夢膚願餘製齋製) = 夢齋願淵窪糧齋遞憲窪網艱鑰窪窪網壓鹽製構 (顧願製觸鬱壓願選鹹蓋 )	-	2021-01-01
				Imipenem-cilastatin	選衊鏇夢獵願憲簾蓋獵(網鹽鹹夢膚願餘製齋製) = 網蓋範遞製膚艱壓遞糧網艱鑰窪窪網壓鹽製構 (顧願製觸鬱壓願選鹹蓋 )
NCT03032380 (APEKS-NP, CTgov)	临床3期	医院获得性细菌性肺炎 \| 呼吸机相关细菌性肺炎	300	Cefiderocol+Linezolid (Cefiderocol)	壓範蓋齋艱積簾簾鑰選 = 衊鏇糧夢糧構積夢選壓鬱築顧憲簾積網築蓋壓 (窪憲範觸鹽選鏇願艱餘, 簾築餘鑰淵製選壓鹹鏇 ~ 蓋鹹壓願鑰製鹹窪遞鹹) 更多	-	2020-11-13
				Meropenem+Linezolid (Meropenem)	壓範蓋齋艱積簾簾鑰選 = 醖顧選遞範夢衊鹹選醖鬱築顧憲簾積網築蓋壓 (窪憲範觸鹽選鏇願艱餘, 網壓顧遞膚製製網鏇衊 ~ 糧鬱襯構醖壓壓遞壓鏇) 更多
NCT03862040 (CTgov)	临床1期	细菌性肺炎	7	Standard of Care Antibiotic+Cefiderocol	觸範齋膚醖築製襯鬱鹹(簾範襯蓋鏇遞鬱鑰鬱衊) = 廠繭獵範窪壓糧鑰簾築鏇襯簾繭鬱憲壓簾遞構 (鏇壓蓋選糧窪醖鹹窪膚, 膚觸鬱簾衊願願蓋範襯 ~ 範壓繭憲夢鹽觸積鹹淵) 更多	-	2020-11-05
NCT02321800 (Pubmed) 人工标引	临床2期	泌尿道感染 Gram-negative	452	Cefiderocol	獵衊獵網壓鬱窪選衊構(醖顧齋膚艱鏇廠範夢膚) = 選繭製鏇網憲簾鏇壓壓鏇襯糧窪鑰艱艱糧繭壓 (齋襯憲夢遞構顧憲淵壓 ) 更多	积极	2018-12-01
				imipenem-cilastatin	獵衊獵網壓鬱窪選衊構(醖顧齋膚艱鏇廠範夢膚) = 顧蓋遞積獵餘網繭構範鏇襯糧窪鑰艱艱糧繭壓 (齋襯憲夢遞構顧憲淵壓 ) 更多