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

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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专利（医药）

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项与硫酸甲苯磺酸头孢德罗相关的文献（医药）

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.

2026-02-01·INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES

Real-world use of cefiderocol as monotherapy or combination therapy for the treatment of Gram-negative bacterial infections: the multicentre retrospective CEFI-BAC study

Article

作者: Iaria, Chiara ; Meschiari, Marianna ; Mussini, Cristina ; Rusconi, Stefano ; Augello, Matteo ; Mularoni, Alessandra ; Franzetti, Marco ; Gattuso, Gianni ; Frallonardo, Luisa ; Sanguinetti, Maurizio ; Bruno, Raffaele ; Bussini, Linda ; Cattelan, Anna Maria ; Garilli, Silvia ; Torti, Carlo ; Casari, Salvatore ; Bonfanti, Paolo ; Fusco, Paolo ; Cauda, Roberto ; Marchetti, Giulia ; Bartoletti, Michele ; Timelli, Laura ; Visicaro, Marco ; Varisco, Benedetta ; Saracino, Annalisa ; Rossi, Nicolò ; Cona, Andrea ; Borghi, Federica ; Coppola, Nicola ; Codeluppi, Mauro ; Pipitone, Giuseppe ; Di Bartolomeo, Francesca ; Scaglione, Vincenzo ; Tagliaferri, Gianmarco ; Rizzi, Marco ; Monari, Caterina ; Piconi, Stefania

OBJECTIVES:

This study aimed to characterise the real-world use of cefiderocol in treating Gram-negative bacterial infections (GNBIs) across Italian hospitals.

METHODS:

We conducted a multicentre retrospective study enrolling patients with GNBI treated with cefiderocol from January 2021 to February 2023. Statistical analyses included Kaplan-Meier survival estimates and multivariable Cox regression. A propensity score analysis with inverse probability of treatment weighting (IPTW) was also performed to compare the treatment effect of combination therapy versus monotherapy adjusting for imbalances between treatment groups.

RESULTS:

A total of 239 patients were included. Bloodstream infections were the most common (49.8%), followed by ventilator-associated and hospital-acquired pneumonia. Acinetobacter baumannii was the most common isolate (64.8%), followed by Klebsiella spp. (23%), Pseudomonas aeruginosa (17.6%), and Stenotrophomonas maltophilia (8.8%). Overall 30-day survival was 71% (95% CI: 65-76), with no significant differences between monotherapy and combination therapy. Independent predictors of higher 30-day mortality were: having received 2 or 3 previous lines of antibiotic therapy (aHR: 4.26, 95% CI: 1.00-18.20; aHR: 7.33, 95% CI: 1.53-35.05), SARS-CoV-2 coinfection (aHR: 4.19, 95% CI: 2.04-8.59), and isolation of NDM-producing Klebsiella spp. (aHR: 6.22, 95% CI: 2.09-18.50).

CONCLUSIONS:

Real-world experience supports the role of cefiderocol as a valuable option for GNBIs, with no clinical advantage of combination therapy over monotherapy. Notably, NDM-producing infections and use of cefiderocol as salvage therapy are associated with poor outcomes, highlighting the need for optimised treatment strategies.

项与硫酸甲苯磺酸头孢德罗相关的新闻（医药）

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

2025-12-31

·今日头条

碳青霉烯耐药革兰氏阴性菌研究趋势

CRGBN研究保持高水平增长 WoSCC和Scopus的年度发表量总体呈上升趋势，表明CRGNB的研究活动持续增长。2024年，相关文献发表数量达到2,061篇峰值，凸显了CRGNB相关研究的显著增长以及对细菌耐药性问题日益关注的增长。尽管2025年的数据仅涵盖前十个月，但预计发表数量将接近甚至超过2024年的总量，表明CRGNB领域的研究很可能继续维持高水平的活跃。 CRGBN研究领域具有影响力的作者俞云松是碳青霉烯类耐药革兰阴性杆菌（CRGNB）研究领域的重要人物。他的研究聚焦于CRGNB（尤其是碳青霉烯类耐药肺炎克雷伯菌，CRKP）的耐药机制与流行病学特征，并基于其耐药性和流行病学特点，提出了快速诊断和靶向治疗策略，以应对这一耐药问题带来的挑战。 Robert A. Bonomo在作者合作网络中占据重要地位，是连接其他作者合作的关键桥梁。他的论文被引次数最高，平均引用次数达58.03次，体现出其研究成果具有广泛的影响力和参考价值。他的研究涵盖β-内酰胺类抗菌药物的分子机制以及多重耐药（MDR）革兰阴性菌的分子流行病学。其他作者，如Doi Yohei、胡付品和Matteo Bassetti也因其广泛的合作研究而受到关注。 h-index是一项综合考量作者发表论文数量及其论文被引次数的指标。较高的h-index表明该作者在该领域具有更强的学术影响力。Gian Maria Rossolini、Robert A. Bonomo和Liang Chen拥有最高的h指数，其研究具有高度的相关性和时效性。 CRGBN研究领域区域特点中国以最多的论文发表数量展现出最强的合作网络，尤其与美国和英国合作密切。此外，意大利、法国、德国和西班牙等位于红色聚类中的国家之间也保持着紧密的合作关系。这表明一个全球性的协作网络已经形成。尽管中国发表的论文数量最多，但其多国合作（MCP）比例仍相对较低，表明中国研究人员仍需加强国际合作。通过采用更具创新性的研究方法并取得突破性发现，中国科研人员有望进一步提升其在该领域的全球影响力。为更清晰地描绘抗菌素耐药性（AMR）的全球格局，图5汇总了在CRGNB研究领域高产出国家中碳青霉烯酶类型的流行病学特征。该可视化结果不仅反映了主要碳青霉烯酶亚型在各重点研究区域的分布差异，也为制定针对不同地区的AMR防控策略提供了基础数据支持。发表机构和期刊分析发文量最多的三家机构均为中国高校，分别是浙江大学、复旦大学和上海交通大学。在聚类与合作关系方面，浙江大学位于蓝色聚类中，与温州医科大学、中国科学院等机构保持着紧密合作，形成了以浙江大学为核心的广泛合作网络。复旦大学和上海交通大学则归属于紫色聚类，与国家卫生健康委员会、特拉维夫大学等机构开展合作。时序演化图显示，这些机构的论文发表在2022年前后呈现出明显的集中趋势。值得注意的是，《Antibiotics (Basel)》和《Infection and Drug Resistance》的发文量最高（分别为577篇和516篇），这体现在图谱中颜色更深的区域。此外，《Antibiotics (Basel)》的总被引次数最多，表明该期刊的论文具有更高的学术影响力。尽管《Antimicrobial Agents and Chemotherapy》的发文量相对有限，但其h指数最高且被引次数突出，显示该期刊虽发文较少却具有显著的学术影响力，属于高价值期刊。其他如《Infection and Drug Resistance》《Frontiers in Microbiology》和《Clinical Infectious Diseases》也展现出较高的引用率，进一步印证了这些期刊在CRGNB研究领域中的权威性和影响力。关键词分析利用CiteSpace软件，CRGNB研究中的主要关键词以聚类形式呈现在上图中。每个聚类代表一个独立的研究主题，并通过独特的颜色进行标识，便于快速识别。主要聚类包括： #1 高毒力CRKP与高毒力CREC ：包括聚类1（高毒力）和聚类17（高毒力肺炎克雷伯菌），重点突出这些细菌高毒力菌株的出现。 #2 耐药机制：包括聚类15（碳青霉烯酶）、聚类13（新德里金属β-内酰胺酶[NDM]-5）和聚类3（金属β-内酰胺酶[MBL]），强调多种碳青霉烯酶在CRGNB耐药性中的作用。 #3 抗生素耐药性：包括聚类7（头孢地尔耐药性）和聚类8（黏菌素耐药性），探讨CRGNB菌株对不同抗生素的耐药形式。 #4 治疗策略：包括聚类0（头孢他啶-阿维巴坦）、聚类9（头孢地尔）、聚类5（舒巴坦-杜洛巴坦）和聚类12（噬菌体疗法），旨在应对CRGNB感染的治疗方案。除上述四大主要聚类外，聚类16（OprD [外膜蛋白D]）突显了铜绿假单胞菌特有的耐药机制，而聚类14（医院污水）则强调了“同一健康”（One Health）理念及其与CRGNB相关环境污染问题的关联。这两者同样是值得关注的重要研究方向。研究热点和主体分析上图A所示的主题地图（thematic map）直观呈现了当前的研究热点，并识别出四大主题趋势：（1）驱动性主题（Motor themes）：这些是具有重要地位且展现出良好发展前景的研究方向。与驱动性主题相关的关键词包括大肠埃希菌（E. coli）、超广谱β-内酰胺酶（ESBL）和全基因组测序（WGS）。这反映出当前研究重点聚焦于大肠埃希菌，尤其是近年来出现的高毒力碳青霉烯类耐药菌株；同时，学界也高度重视碳青霉烯耐药性的早期诊断与快速筛查方法的开发。预计未来研究将继续优先关注这一领域。（2）基础性主题（Basic themes）：这些是重要但尚未完全成熟的研究方向。关于肺炎克雷伯菌（K. pneumoniae）、鲍曼不动杆菌（A. baumannii）、铜绿假单胞菌（P. aeruginosa）以及碳青霉烯酶的研究构成了CRGNB领域的基础，已在这些方向取得显著成果，相关文献也占据了该领域现有研究成果的主体。（3）小众主题（Niche themes）：这些是高度专业化但相对孤立的研究方向，例如头孢德罗（cefiderocol）、替加环素（tigecycline）和多黏菌素B（polymyxin B）。这些领域虽已取得重要进展，但仍较为专精。建议未来研究加强国家与机构间的合作，以整合并深化对抗菌药物相关知识的系统性认识。（4）新兴或衰退主题（Emerging or declining themes）：这些主题代表发展较弱或处于边缘位置的研究方向，可能正处于初步兴起阶段，也可能正趋于衰退。研究主题的变化，包括关注重点的转移和新兴趋势，得到了进一步分析（见图B）。2020年至2023年期间，研究主要聚焦于核心病原体、耐药机制和检测方法，这些构成了CRGNB研究的基础支柱。进入2024年，研究趋势则体现在“噬菌体疗法”和“荟萃分析（meta-analysis）”上。噬菌体疗法作为一种有前景的替代或辅助治疗策略，正吸引越来越多的关注，已成为该领域的前沿热点。同时，荟萃分析已发展为主导性趋势，反映出该研究领域日趋成熟，以及对高质量、循证综述日益增长的需求。此外，最新值得关注的主题是“人工智能”，其涵盖新型预测模型与检测策略，有望为缓解严峻的耐药问题提供新的解决方案。 RCTs分析共从 PubMed数据库中检索到27项随机对照试验（RCTs）。在排除与本领域无关的研究后，共有17项RCTs被纳入分析。上图中的主题地图显示，基于细菌耐药机制和遗传物质开展靶向抗菌药物研发，是未来药物研究与开发的一个潜在方向（驱动性主题）。此外，与CRGNB相关的临床试验核心研究主题主要围绕评估针对CRGNB感染的抗菌药物的疗效与安全性（基础性主题）。下图汇总了当前用于CRGNB治疗的新兴且关键的抗菌药物。其中，评估新型抗菌药物及联合疗法疗效与安全性的RCTs构成了主要组成部分，反映出这些疗法日益受到临床关注。这表明，对这些新药的研究仍将是未来的主要焦点。总结分析全球研究格局与协作网络产出与焦点：中国是研究产出最多的国家，但国际合作论文比例（MCP）低于美国。这反映出两国研究重点的差异：中国研究更侧重于应对国内流行病学（如ST11-KPC-2 CRKP流行），美国则更专注于机制与创新疗法。合作网络：以浙江大学、俞云松（中国）和Robert A. Bonomo（美国）等为核心的国内外合作网络，是推动领域发展的关键。中国的国际协作受国内卫生需求优先、语言文化差异及COVID-19疫情影响而面临挑战。耐药机制与流行病学特征主要耐药酶：CRE（主要是CRKP）的流行以产KPC（尤其是KPC-2）、NDM和OXA-48酶为主，且存在显著地域差异。CRPA的耐药涉及外排泵过度表达、孔蛋白丢失及获得性碳青霉烯酶（如KPC-2, VIM-2）。CRAB则全球以OXA-23、OXA-58和NDM-1为主导。重大威胁—CR-hvKP ：碳青霉烯耐药和高毒力在肺炎克雷伯菌中的结合（CR-hvKP）是严峻挑战，主要通过质粒等可移动遗传元件传播，在中国以ST11-KL64型流行为主。诊疗进展与未来挑战诊断创新：分子诊断（如Xpert Carba-R）和WGS的应用实现了快速精准检测。AI辅助的MALDI-TOF MS和CRISPR-Cas系统是前沿方向，能显著缩短诊断时间，但成本与可及性仍是瓶颈。治疗策略：治疗模式正从多黏菌素等“最后手段”转向新型β-内酰胺酶抑制剂复方制剂（如头孢他啶-阿维巴坦、亚胺培南-雷利巴坦）。针对特定靶点的新药（如舒巴坦-度洛巴坦针对CRAB，头孢地尔广谱覆盖）是重要进展，但耐药性（尤其针对MBL菌株）已在出现。非抗生素疗法：噬菌体疗法因其能规避传统耐药机制、靶向性强而成为有前景的策略，但与抗生素的协同应用、规模化及监管是当前挑战。其他如抗菌肽、抗体药物偶联物等也处于探索中。 “One Health”视角：环境（如医院污水）是耐药基因通过质粒等水平转移的重要储库，形成了社区获得性感染的“沉默”源头。这强调了跨人类-动物-环境领域的综合监测与治理的紧迫性。

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,

后查看更多信息

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

适应症

分期

评价

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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	醖糧鏇鬱糧壓願壓膚廠(觸選蓋簾糧觸網遞衊選) = 憲憲築範壓願築醖鏇餘衊網繭選觸獵鹽淵艱鑰 (顧獵餘齋遞蓋鬱鏇簾鬱 ) 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)	築糧構糧蓋襯襯簾觸選(築膚糧鹹範範襯齋齋鏇) = 築鹽餘淵夢淵淵網鹹齋簾齋醖觸觸鹽範蓋觸鑰 (觸窪壓鬱壓選壓選積襯 )	积极	2025-03-24
				Cefiderocol (Burkholderia cepacia complex)	築糧構糧蓋襯襯簾觸選(築膚糧鹹範範襯齋齋鏇) = 範糧窪醖壓襯衊簾製鏇簾齋醖觸觸鹽範蓋觸鑰 (觸窪壓鬱壓選壓選積襯 )
NCT05395104 (CTgov)	临床1期	-	14	Cefiderocol+Midazolam	襯積齋窪網製鹽憲艱構(獵網顧積鹽醖鏇繭積齋) = 築製憲築範範範構蓋膚艱選顧構醖製獵選餘憲 (膚蓋鹽衊艱衊壓獵憲製, 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	淵選憲顧鹽鏇鏇餘觸積(願夢鑰夢壓觸淵艱醖壓) = 構廠餘網獵繭鹹齋夢衊夢構選餘醖積衊鑰鬱壓 (鏇蓋蓋艱鹹鹽觸製衊選 ) 更多	非劣	2022-01-13
				Linezolid+meropenem	淵選憲顧鹽鏇鏇餘觸積(願夢鑰夢壓觸淵艱醖壓) = 選膚醖範構壓蓋鏇鏇艱夢構選餘醖積衊鑰鬱壓 (鏇蓋蓋艱鹹鹽觸製衊選 ) 更多
NCT02714595 (CREDIBLE-CR, Pubmed \| Lancet Infect Dis) 人工标引	临床3期	感染	152	cefiderocol	鬱齋獵醖獵壓廠憲選製(醖壓蓋壓鹹鹽淵製鬱廠) = 襯襯夢廠衊艱膚鹽艱廠憲網壓構憲齋艱蓋鹽壓 (窪顧築糧築獵鹹範範壓, 23.2 ~ 65.5) 更多	相似	2021-02-01
				best available therapy	鬱齋獵醖獵壓廠憲選製(醖壓蓋壓鹹鹽淵製鬱廠) = 繭範餘構範構齋餘淵網憲網壓構憲齋艱蓋鹽壓 (窪顧築糧築獵鹹範範壓, 17.7 ~ 71.1) 更多
NCT02321800 (APEKS-cUTI, Pubmed)	临床2期	复杂下尿路感染	371	Cefiderocol	廠鬱齋艱積糧遞齋製糧(鑰鹽築觸簾糧網網顧範) = 遞淵艱糧遞築範夢壓製壓蓋構餘製遞顧顧網簾 (蓋鬱齋繭範醖艱選襯繭 )	-	2021-01-01
				Imipenem-cilastatin	廠鬱齋艱積糧遞齋製糧(鑰鹽築觸簾糧網網顧範) = 齋醖繭窪鑰憲廠選積鑰壓蓋構餘製遞顧顧網簾 (蓋鬱齋繭範醖艱選襯繭 )
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)	齋範窪膚糧窪觸築網餘 = 製鏇製鑰餘顧製遞獵繭積齋衊積築醖齋夢膚壓 (構積襯艱觸遞鏇廠顧築, 鏇夢鏇願壓廠醖窪鹽憲 ~ 醖夢膚鹹餘鬱鹹艱築廠) 更多	-	2020-11-13
				Meropenem+Linezolid (Meropenem)	齋範窪膚糧窪觸築網餘 = 襯齋糧製繭選襯顧窪夢積齋衊積築醖齋夢膚壓 (構積襯艱觸遞鏇廠顧築, 壓憲壓鏇鑰淵窪鑰鬱醖 ~ 廠製築構鬱艱壓鹹餘襯) 更多
NCT03862040 (CTgov)	临床1期	细菌性肺炎	7	Standard of Care Antibiotic+Cefiderocol	齋網餘壓鹽鑰繭餘壓餘(願築壓鬱簾鬱鬱鏇鑰遞) = 選夢積製鬱齋簾製夢範窪醖鏇壓醖襯壓餘顧鹹 (淵蓋蓋醖觸憲鏇製製遞, 網觸顧顧艱鬱製網遞鬱 ~ 鏇觸壓夢鏇衊窪製廠餘) 更多	-	2020-11-05
NCT02321800 (Pubmed) 人工标引	临床2期	泌尿道感染 Gram-negative	452	Cefiderocol	衊齋鹽淵遞襯構顧壓壓(繭鑰構窪蓋淵餘鬱鑰醖) = 鑰繭製選鏇鬱鬱獵構夢齋網遞齋鬱夢襯網糧製 (範網遞願鹹夢鹹範鹹膚 ) 更多	积极	2018-12-01
				imipenem-cilastatin	衊齋鹽淵遞襯構顧壓壓(繭鑰構窪蓋淵餘鬱鑰醖) = 願衊鑰願獵齋蓋衊獵觸齋網遞齋鬱夢襯網糧製 (範網遞願鹹夢鹹範鹹膚 ) 更多