CEFtolozane-Tazobactam for the Empiric Anti-bacterial Treatment of Neutropenic Fever in Hematology Patients; a Single-arm, Single-center, Open-label Clinical Trial (CEF-10 Study)

Patients with blood cancers and those who received a bone marrow transplant frequently have low circulating white blood cell countS. Fever in patients with low white blood cell count requires early appropriate antibiotic treatment to prevent complications including death. Bacteria have increasingly become more resistant to existing antibiotic options. Ceftolozane-tazobactam is a newer type of antibiotic that has been shown to be safe and effective in infections caused by several types of resistant bacteria that can cause serious infections in individuals with low blood count. This study aims to examine the effectiveness of this antibiotic in these types of patients.
Patients with blood cancer and those who have received a bone transplant will be offered the option to join this study if they develop unexplained fever. If informed consent is granted, they will receive ceftolozane-tazobactam on top of the usual care that such patients receive. The patients will then be followed very closely to check their response to the treatment and if they develop any untoward events. The study will include 164 patients over an estimated 2 year period.
The study is funded by Merck & Co, the company that manufactures the study antibiotic. However, Merck & Co. will not be involved in the actual running of the study, the collection of the study results or their analysis and interpretation. The study protocol has been reviewed and approved by an independent research oversight committee.

开始日期2022-08-01

申办/合作机构

Hamad Medical Corp.

[+1]

NCT03963297

/ CompletedN/AIIT

Multicenter Evaluation of the Susceptibility of Enterobacteriaceae and Pseudomonas Aeruginosa to Ceftolozane/Tazobactam Combination

Ceftolozane/tazobactam is a new antibiotic with broad spectrum activity. This molecule is currently one of the most active beta lactams against Pseudomonas aeruginosa and its spectrum of activity also includes enterobacteriaceae producing a broad spectrum beta-lactamase (EBLSE). Ceftolozane/tazobactam is currently marketed for the treatment of complicated intra-abdominal infections and complicated urinary tract infections. These intra-abdominal and urinary infections are mainly caused by enterobacteriaceae (Escherichia coli, Klebsiella pneumoniae) and more rarely by P. aeruginosa. Concerning enterobacteriaceae, French epidemiology reports a prevalence of BLSE of between 10 and 15% in E. coli and 10%-30% in K. pneumoniae.

开始日期2019-03-01

申办/合作机构

Fondation Hopital Saint-Joseph

NCT03485950

/ Completed临床2期IIT

An Investigator Initiated, Phase II Single-Center, Randomized, Open-Label, Prospective, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftolozane-Tazobactam Plus Vancomycin, Linezolid Versus Standard of Care Plus Vancomycin, Linezolid as Empiric Therapy in Febrile Neutropenic Adults With Cancer

The goal of this clinical research study is to learn if the study drug ceftolozane-tazobactam is more effective in controlling febrile neutropenia (fever and low white blood cell counts) than using approved antibiotics in patients with cancer. The safety of ceftolozane-tazobactam will also be studied.
This is an investigational study. Ceftolozane-tazobactam is FDA approved and commercially available to treat certain types of infections. It is not approved for the treatment of febrile neutropenia, either by itself or in combination with other antibiotics. Its use to treat febrile neutropenia is investigational.
All other antibiotics given on this study are FDA approved and commercially available for the treatment of infections. However, only cefepime is specifically FDA approved to treat febrile neutropenia. The study doctor can explain how the study drugs are designed to work.
Up to 100 participants will take part in this study. All will be enrolled at MD Anderson.

开始日期2018-05-16

申办/合作机构

The University of Texas MD Anderson Cancer Center

[+2]

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项与头孢洛扎相关的文献（医药）

2025-07-01·JOURNAL OF HOSPITAL INFECTION

Successful implementation of a bundle to prevent increased excessive-spectrum antimicrobial use under new EUCAST susceptibility definitions: a quasi-experimental study in a tertiary hospital

Article

作者: Simonetti, A F ; Navarro, F ; López-Contreras, J ; Escolà-Vergé, L ; de Gamarra-Martínez, E Fernández ; Rivera, A ; Zarate-Tamames, B ; Gras-Martin, L ; Figueras-Roig, A ; Duch-Llorach, P ; Ramos, J Ruiz ; Moreno-Martinez, M-E

BACKGROUND:

This study evaluated the effectiveness of an implementation-bundle to prevent increased targeted excessive-spectrum antibiotics for wild-type Pseudomonas aeruginosa (PA) infections, following the introduction of 2019 EUCAST susceptibility categories redefinition.

METHODS:

This was a single-centre, quasi-experimental study at a tertiary University Hospital. All consecutive adult patients with wild-type PA infections between July 2023 and April 2024 were included and analysed across three-month periods: before the EUCAST update (Period 1), after the update with audit-feedback (Period 2), and after the update without audit-feedback (Period 3). The implementation-bundle included: (1) in-person educational sessions before the introduction of the redefinition; and (2) in antimicrobial susceptibility reports, replacing 'I' with 'SE', with a clarifying footnote and dosing information. An audit-feedback intervention was conducted during the first three months after the introduction of the redefinition. Selective reporting of antimicrobial susceptibility testing results was already in place in our hospital. Primary outcomes included targeted meropenem, and ceftolozane/tazobactam prescriptions; secondary outcomes were optimal anti-pseudomonal dosing and infectious diseases (IDs) consultations.

FINDINGS:

Among 158 patients (55 Period 1, 60 Period 2, 43 Period 3), targeted meropenem prescriptions did not increase (7.3% vs 6.7% (P=0.898) vs 0% (P=0.071)). No patients received targeted ceftolozane/tazobactam. ID consultations decreased (56.4% vs 38.3% (P=0.053) vs 34.9% (P=0.034)) and correct anti-pseudomonal dosing improved (70.9% vs 93.3% (P=0.002) vs 95.3% (P=0.002)). Risk factors for targeted meropenem prescriptions included age <65 years, immunosuppression, septic shock, intensive care unit admission, and empirical excessive-spectrum antimicrobial use.

CONCLUSION:

This implementation-bundle enabled the introduction of EUCAST susceptibility categories redefinition without increasing targeted excessive-spectrum antibiotics or ID consultations, while optimizing dosing.

2025-06-01·Infectious Diseases Now

Antimicrobial activity of new anti-Pseudomonas beta-lactam-beta-lactamase inhibitors against Pseudomonas aeruginosa respiratory isolates recovered during the study for Monitoring Antimicrobial Resistance Trends (SMART) program in France (2016–2022)

Article

作者: Pailhoriès, Hélène ; Eckert, Catherine ; Pierrat, Gautier ; Woerther, Paul-Louis ; Corvec, Stéphane ; Kempf, Marie ; Zins, Charlie ; Bourge, Xavier ; Boyer, Sophie ; Dahyot, Sandrine ; Chenouard, Rachel

OBJECTIVES:

To assess the susceptibility of ceftolozane/tazobactam (C/T) and comparators to Pseudomonas aeruginosa isolates recovered from respiratory-tract-infections (RTI) between 2016-2022 in the French SMART study.

METHODS:

Antibiotic susceptibility testing and minimum inhibitory concentrations (MICs) of 717 P.aeruginosa isolates collected in five French hospitals were determined and interpreted according to the EUCAST-2022 guidelines. P. aeruginosa isolates resistant (R) to imipenem and/or C/T were screened by PCR for extended-spectrum-β-lactamases (ESBLs), AmpC and carbapenemase genes. The identified genes were sequenced and the variants determined.

RESULTS:

All in all, 96.5 % of P. aeruginosa isolates were susceptible to C/T, comparable to the susceptibilities of meropenem-vaborbactam (MVB = 96.5 %), imipenem/relebactam (IMI/REL = 96.9 %) and ceftazidime-avibactam (C/A = 97.0 %). MIC₅₀ and MIC₉₀ for C/T were 0.5 and 2 mg/L respectively against the 717 isolates. Among the 242 isolates (33.7 %) resistant to at least one anti-Pseudomonas β-lactam, close to 90 % were susceptible to C/T, C/A, MVB and IMI/REL. Among the 80 isolates resistant to piperacillin-tazobactam, cefepime and ceftazidime, 76.3 % were susceptible to C/T and only IMI/REL and amikacin reached susceptibility exceeding 80 %. Among the 32 isolates resistant to imipenem and meropenem, susceptibility exceeding 60 % was observed only for IMI/REL, C/T, and C/A. For these strains, the MIC₅₀ of C/T was 2 mg/L, while that of C/A was at the resistance threshold (8 mg/L). IMI/REL had the strongest activity (72 %) against the 25 isolates resistant to C/T. Lastly, 53 imipenem and/or C/T-R isolates harbored a class C β-lactam (blaPDC) variant, and one of them also carried the bla_PER-1 gene and another, the bla_VIM-2 gene.

CONCLUSION:

C/T is a reliable treatment option in RTI caused by P. aeruginosa.

2025-05-06·Microbiology Spectrum

Antimicrobial susceptibility and resistance mechanisms to antipseudomonal β-lactams in Pseudomonas aeruginosa isolates from blood

Article

作者: Kaku, Norihito ; Hasegawa, Hiroo ; Murata, Mika ; Kosai, Kosuke ; Mukae, Hiroshi ; Izumikawa, Koichi ; Yanagihara, Katsunori ; Mitsumoto-Kaseida, Fujiko

ABSTRACT:

Bloodstream infection caused by Pseudomonas aeruginosa with antimicrobial resistance can be difficult to treat. Herein, we investigated antimicrobial susceptibility to major antipseudomonal β-lactams and analyzed the relationship between resistance mechanisms and susceptibilities in P. aeruginosa isolates from blood. A total of 97 isolates possessing no carbapenemase gene were included in this study. The susceptibility rates to piperacillin, piperacillin/tazobactam, ceftazidime, and cefepime were in the 80% range, while 74.2% and 80.4% of the isolates showed susceptibility to imipenem and meropenem, respectively. None of the isolates showed resistance to ceftolozane/tazobactam or cefiderocol, and only one isolate each showed intermediate resistance (susceptibility rate, 99.0% each). The susceptibility rate was lowest for aztreonam (71.1%). The most prevalent susceptibility pattern was susceptible to all agents (56 isolates), followed by not susceptible only to aztreonam (nine isolates) or imipenem (seven isolates), and susceptible only to both ceftolozane/tazobactam and cefiderocol (six isolates). Multivariate logistic regression analysis revealed significant correlations between decreased oprD expression and decreased susceptibility to carbapenems; between increased ampC expression and non-susceptibility to piperacillin, piperacillin/tazobactam, and ceftazidime; and between increased mexA expression and decreased susceptibility to piperacillin, piperacillin/tazobactam, cefepime, aztreonam, and meropenem. These findings highlight the correlations between the expression of AmpC β-lactamase, OprD porin, and efflux pumps and non-susceptibility to β-lactams in P. aeruginosa isolates from blood. In contrast to traditional β-lactams, the stability of ceftolozane/tazobactam and cefiderocol against the resistance mechanisms was confirmed.

IMPORTANCE:

Pseudomonas aeruginosa is a significant pathogen in hospital-acquired bloodstream infection (BSI) whose treatment requires the appropriate antimicrobial selection in consideration of antimicrobial resistance and resistance mechanisms. Although antipseudomonal β-lactams are key antimicrobial agents, several molecular mechanisms, including β-lactamases, OprD porin, and efflux pumps, are known to be intricately involved in β-lactam resistance. This study evaluated susceptibility profiles of P. aeruginosa to antipseudomonal β-lactams and revealed the correlations between susceptibility and the expression of genes underlying the relevant resistance mechanisms. The results demonstrate the potent in vitro activity of two new agents, ceftolozane/tazobactam and cefiderocol, against P. aeruginosa showing resistance to traditional antipseudomonal β-lactams. This study provides insights into the mechanisms underlying antipseudomonal β-lactam resistance in P. aeruginosa , highlighting the potential of ceftolozane/tazobactam and cefiderocol for use against P. aeruginosa BSI.

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2025-03-04

·医药观澜

8款新药在中国获批上市，3款治疗癌症！来自强生、复星医药等公司

▎药明康德内容团队报道根据中国国家药监局（NMPA）官网及公开信息，在刚刚过去的2025年2月，至少有8款新药*在中国获批上市。这些新药涵盖了单抗、双抗、小分子等药物类型，为肺癌、头颈癌、多发性骨髓瘤、丙肝、肾病等带来新的治疗选择。本文我们就一起来看看这些新药有哪些特点。（*此处的新药是指NMPA注册分类为1类、3.1类和5.1类和部分2.2类进口新药，本文仅统计首次申报上市新药，不含新适应症）神州细胞：菲诺利单抗注射液作用机制：抗PD-1单抗适应症：头颈部鳞状细胞癌、肝细胞癌 2月8日，NMPA宣布批准神州细胞的1类新药菲诺利单抗注射液上市，与含铂化疗联合用于复发性和/或转移性头颈部鳞状细胞癌（HNSCC）的一线治疗。菲诺利单抗是一款重组人源化抗PD-1 IgG4型单克隆抗体。一项3期临床研究结果表明，与单纯化疗相比，菲诺利单抗联合化疗可显著延长总生存期（OS）和无进展生存期（PFS），并提高客观缓解率（ORR）。其中，联合治疗组的中位OS达14.1个月，，在CPS≥20的人群中长达20.1个月，较化疗组（10.5个月）具有明显优势，同时中位缓解持续时间(DoR)延长至19.3个月，为患者带来更持久的获益。 2月28日，菲诺利单抗再次获NMPA批准新适应症，与贝伐珠单抗注射液（SCT510）联合用于既往未接受过系统治疗的不可切除或转移性肝细胞癌患者。一项3期临床研究结果显示，菲诺利单抗联合贝伐珠单抗治疗组和对照组的ORR分别为33%和4%；两组的中位无进展生存期（mPFS）分别为7.1个月和2.9个月，联合治疗组降低疾病进展风险50%；中位OS分别为22.1个月和14.2个月，联合治疗组降低患者死亡风险40%。东阳光药：磷酸萘坦司韦联合艾考磷布韦作用机制：NS5A抑制剂联合NS5B抑制剂适应症：慢性丙肝病毒感染 2月8日，NMPA宣布批准东阳光药业1类创新药磷酸萘坦司韦胶囊上市，该药适用于与艾考磷布韦片联用，治疗初治或干扰素经治的基因1、2、3、6型成人慢性丙型肝炎病毒（HCV）感染，可合并或不合并代偿性肝硬化。磷酸萘坦司韦为NS5A抑制剂，艾考磷布韦为NS5B抑制剂，这两款药均为东阳光药自主研发的1类新药。2024年9月，该联合疗法治疗慢性丙肝的2期临床研究成果全文在线发表于《中华肝脏病杂志》。全分析集分析结果显示总体SVR12为96.7%；按基因型总结，该方案在基因1型、2型、3型和6型受试者中SVR12分别为96.2%、100.0%、83.3%、100.0%。代偿期肝硬化和无肝硬化受试者总体SVR12分别为100%和96.2%，表明受试者肝硬化状态对疗效结果无影响。强生：埃万妥单抗作用机制：EGFR/MET双特异性抗体适应症：EGFR 20号外显子插入突变非小细胞肺癌 2月11日，强生（Johnson & Johnson）宣布EGFR/MET双特异性抗体疗法埃万妥单抗注射液已获得NMPA批准上市，用于与卡铂和培美曲塞联合给药，用于经检测确认携带表皮生长因子受体（EGFR）20号外显子插入突变的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者的一线治疗。根据文献报道，EGFR 20号外显子插入突变是第三大常见的突变类型。通常由该突变驱动的非小细胞肺癌相较于EGFR常见突变驱动的肺癌患者预后更差，生存期更短。此外，这类患者对目前已获批上市的第三代EGFR-TKI靶向药物和化疗的疗效有限，患者急需更加有效的治疗方案。此次埃万妥单抗的获批是基于一项随机、开放标签、PAPILLON临床3期研究结果。该研究表明，与单独化疗相比，埃万妥单抗联合化疗可将疾病进展或死亡风险降低61%。强生：塔奎妥单抗作用机制：GPRC5D×CD3双抗适应症：多发性骨髓瘤 2月11日，强生宣布塔奎妥单抗注射液（talquetamab）已经获得NMPA批准上市，单药适用于既往接受过至少三线治疗（包括一种蛋白酶体抑制剂、一种免疫调节剂和一种抗CD38抗体）的复发或难治性多发性骨髓瘤（RRMM）成人患者。塔奎妥单抗是一款皮下注射的“first-in-class”GPRC5D×CD3双抗双特异性抗体。 GPRC5D主要在恶性浆细胞中表达，这一特性为这种异质性血液疾病提供了全新的治疗思路。临床研究显示，塔奎妥单抗通过重定向T细胞诱导杀伤带有GPRC5D表达的多发性骨髓瘤细胞，从而抑制肿瘤的形成和生长。该产品被批准的治疗频率包括初始递增剂量后每周或每两周皮下注射（SC），为医生提供了灵活便捷的治疗方案。经临床验证，塔奎妥单抗总缓解率（ORR）超过70%且应答持久，其中有65%既往接受过T细胞重定向治疗的患者达到缓解。默沙东：注射用头孢洛生他唑巴坦钠作用机制：酶抑制剂复合制剂适应症：复杂性腹腔感染、复杂性尿路感染等 2月11日，根据NMPA官网公示，默沙东（MSD）的新型酶抑制剂复合制剂——注射用头孢洛生他唑巴坦钠在中国获批上市，适用于与甲硝唑联合治疗成人和儿童（出生至18岁以下）患者由敏感革兰阴性和革兰阳性微生物引起的复杂性腹腔感染（cIAI）；治疗成人和儿童（出生至18岁以下）患者由敏感革兰阴性微生物引起的复杂性尿路感染（cUTI）（包括肾盂肾炎）；治疗成人（18岁及以上）患者由敏感革兰阴性微生物引起的医院获得性细菌性肺炎（HABP）和呼吸机相关性细菌性肺炎(VABP)。注射用头孢洛生他唑巴坦钠包含头孢类抗生素头孢洛生（ceftolozane）和β-内酰胺酶抑制剂他唑巴坦（tazobactam）。默沙东新闻稿表示，这一新型酶抑制剂复合制剂药物能够在临床治疗中帮助医生应对日益复杂的耐药感染，为患者带来新的治疗选择。泰诺麦博：斯泰度塔单抗注射液作用机制：抗破伤风毒素单抗适应症：成人破伤风紧急预防 2月11日，泰诺麦博自主研发的重组抗破伤风毒素单克隆抗体新药——斯泰度塔单抗注射液获NMPA批准上市，该产品作为迭代升级的新“破伤风针”，用于成人破伤风紧急预防。泰诺麦博新闻稿表示，该产品通过肌内注射，快速起效，以达到紧急保护。此外，该产品无需皮试，无需留观（门诊患者），无需区分体重和伤口大小，一针一次给药，达到全程保护。研究显示，斯泰度塔单抗在给药后12小时，95.4%的患者达到保护水平，快速起效，显著高于HTIG组（53.2%）。赛生药业：注射用盐酸替拉凡星作用机制：糖肽类抗生素适应症：HABP/VABP 2月13日，赛生药业引进的注射用盐酸替拉凡星获NMPA批准上市，用于治疗由金黄色葡萄球菌敏感分离株引起的医院获得性和呼吸机相关细菌性肺炎（HABP/VABP）。注射用盐酸替拉凡星是一种能够快速杀菌的糖肽类抗生素，对MRSA在内的革兰氏阳性病原菌有杀菌活性。该产品具有独特的双重抗菌作用机制，一方面通过抑制细菌细胞壁合成，另一方面与细菌细胞膜结合，干扰膜的屏障功能——这是万古霉素不具备的一种作用机制，从而快速发挥杀菌作用。与万古霉素相比，替拉凡星的半衰期更长，每日仅需给药一次。复星医药、Ardelyx：盐酸替那帕诺片作用机制：NHE3抑制剂适应症：CKD成人透析患者 2月26日，复星医药从Ardelyx许可引入的全新机制降磷创新药盐酸替那帕诺片获NMPA批准上市，用于控制对磷结合剂疗效不充分或不耐受的慢性肾脏病（CKD）成人透析患者的血清磷水平。盐酸替那帕诺片是一款口服肠道钠/氢交换体3（NHE3）抑制剂，其通过抑制NHE3，使细胞间连接变得紧密，降低肠道磷酸盐吸收的主要途径-细胞旁途径磷酸盐的通透性，减少磷酸盐的吸收，从而降低血磷。根据复星医药新闻稿介绍，替那帕诺可与现有磷结合剂联用，进一步显著降低血磷水平、提升血磷达标率。一项随机、双盲、安慰剂对照研究纳入血液透析的高磷血症患者164例，替那帕诺与磷结合剂联用治疗8周，较单用磷结合剂治疗，血磷进一步下降0.57mmol/L。一项多中心、随机、开放标签研究纳入303例磷结合剂治疗不达标的透析患者，将磷结合剂转换为以替那帕诺为基础的降磷方案（替那帕诺30mg BID治疗，若血磷不达标，可加用磷结合剂）治疗10周，血磷达标率提升34.4%-38.2%。除了上述新药，2月还有几款新药在中国获批新适应症，比如康诺亚的IL-4Rα生物制剂司普奇拜单抗注射液获批第三个适应症，用于治疗季节性过敏性鼻炎（SAR）；强生的白介素23抑制剂古塞奇尤单抗获批新适应症，用于治疗中重度活动性克罗恩病，而这也是古塞奇尤单抗在全球范围内首次批准用于中重度活动性成人克罗恩病的治疗。期待这些获批上市的新药能尽快来到患者身边，为他们带来新的治疗选择。参考资料： [1]中国国家药监局（NMPA）官网 [2]各公司官网及公开资料本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权或其他合作需求，请联系wuxi_media@wuxiapptec.com。免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

上市批准临床3期临床结果临床2期

2025-02-11

·医药观澜

刚刚！默沙东复方抗菌疗法在中国获批上市

▎药明康德内容团队报道今日（2月11日），中国国家药监局（NMPA）官网最新公示，由默沙东（MSD）申报的5.1类新药注射用头孢洛生他唑巴坦钠上市申请已获得批准。开资料显示，这是一款复方抗菌药物（商品名为Zerbaxa），包含头孢类抗生素头孢洛生（ceftolozane）和β-内酰胺酶抑制剂他唑巴坦（tazobactam）。默沙东此前已经在中国完成了一项3期临床研究，评估该产品治疗复杂性腹腔感染的疗效和安全性。截图来源：NMPA官网 Zerbaxa是一种抗生素组合产品。该产品最早由Cubist制药开发，默沙东于2014年以总价值约95亿美元现金收购Cubist公司，从而将这款产品纳入麾下。该产品随后于2014年获得美国FDA批准，治疗由某些革兰氏阴性菌导致的复杂性尿路感染，以及与甲硝唑联合治疗复杂性腹腔内感染。2019年6月，FDA宣布批准该产品治疗医院获得性/呼吸器相关的细菌性肺炎（HABP/VABP）。 2022年8月，Int J Infect Dis杂志发表了一项3期临床研究结果，该研究旨在评估Zerbaxa+甲硝唑对比美罗培南治疗中国患者复杂性腹腔内感染（cIAI）的疗效和安全性，主要评估指标为治愈测试（Test-Of-Cure，TOC）中的临床反应率。结果显示，Zerbaxa+甲硝唑和美罗培南组患者的临床治愈率分别为95.2%和93.1%，达到非劣效性标准。研究人员认为，在中国成年cIAI患者中，Zerbaxa+加甲硝唑的疗效不逊于美罗培南，且安全性相当。复杂性腹腔内感染（cIAI）是一种院内或社区获得性感染，是由空腔脏器延伸到腹膜腔形成的腹膜炎或者脓肿的感染疾病。cIAI包括腹腔脓肿、胃或肠穿孔、腹膜炎、阑尾炎、胆囊炎、憩室炎等。cIAI由不同的病原体引起，包括革兰阴性菌、革兰阳性菌和厌氧菌。希望默沙东这款抗菌复方疗法的获批，能够尽快惠及更多的患者。参考资料： [1]2025年02月11日药品批准证明文件送达信息 From https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20250211152345189.html [2] 快讯 | 默沙东宣布95亿美元收购抗生素巨头Cubist制药夯实院内急性护理治疗领域实力. Retrieved Dec 09, 2014. From https://mp.weixin.qq.com/s/Estm7s9TSc_BzSFhKoK5zA [3]ClinicalTrials官网. From https://clinicaltrials.gov/study/NCT03830333 [4]Yihong Sun et al .(2022) A phase III, multicenter, double-blind, randomized clinical trial to evaluate the efficacy and safety of ceftolozane/tazobactam plus metronidazole versus meropenem in Chinese participants with complicated intra-abdominal infections.Int J Infect Dis. DOI: 10.1016/j.ijid.2022.08.003 本文由药明康德内容团队根据公开资料整理编辑，欢迎个人转发至朋友圈。转载授权及其他合作需求，请联系wuxi_media@wuxiapptec.com。免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

临床3期并购上市批准临床结果微生物疗法

2025-02-06

·化学经纬

书籍分享||新药化学全合成路线手册

内容介绍本书归纳和综述了新药的化学合成路线。覆盖范围为近5年美国FDA批准上市的新分子实体药共109个。针对每一个药物，本书给出了药物简介，药物化学结构信息，产品上市信息，药品专利保护和市场独占权保护信息，化学全合成路线和参考文献等。这些合成路线大多是目前制药工业中正在使用的化学合成工艺，有较高的实用性和学术价值。对参与反应的起始原料、中间体、反应产物都给出了详细的化学结构。每一步化学合成反应都给出了重要的化学试剂、催化剂、所使用的溶剂、合成反应条件及文献出处等。本书的特点是：作者从浩如烟海的科技文献中，精心挑选出最新、最有实用价值的合成方法，汇编成化学合成路线图，内容简洁，深入浅出，逻辑性强，容易理解，以最少的篇幅表达最多的技术信息，可帮助读者很快找到他们需要的药物合成方法及最可靠的原始科学论文。读者对象： 1.任何从事与化学合成、药物合成、精细化工相关专业的科研人员、企业管理人员。 2.有机化学专业、药学专业、生物制药专业等大专院校的高年级学生、研究生、教师及科研人员。 3.从事客户委托的药物原料与药物中间体合成的科研人员、企业管理人员。编辑推荐对于制药企业而言,一个好的药物全合成路线, 可以大大缩短生产周期,简化生产工艺,降低生产成本,节约能源,减少或消除对环境的化学污染与排放。本书为了顺应我国近年来生物制药及医药工业飞速发展的潮流编写的，详细介绍了近五年美国FDA批准上市的所有（109个）新分子实体药的化学全合成路线。这些全合成路线多数是国外制药厂目前正在使用的工艺，其经济效益及社会效益都是极为显著，因此本书既有较高的科学价值又有很大的实用性。作者简介陈清奇，旅美药学家和化学家，担任美国MedKoo生物医药科研公司总裁，同时兼任美国数家生物制药公司的技术顾问，中国国内数个大学的客座教授。研究领域为药物化学，纳米医学体外诊断技术。书籍目录 Abiraterone Acetate（醋酸阿比特龙）001 Aclidinium Bromide（阿克利溴铵）006 Afatinib（阿法替尼）009 Alcaftadine（阿卡他定）014 Alogliptin（阿格列汀）017 Apixaban（阿哌沙班）022 Apremilast（阿普斯特）028 Avanafil（阿伐那非）033 Axitinib（阿西替尼）038 Azilsartan Kamedoxomil（阿齐沙坦酯钾盐）044 Bazedoxifene（巴多昔芬）048 Bedaquiline（贝达喹啉）053 Belinostat（贝利司他）060 Boceprevir（波西普韦）064 Bosutinib（博舒替尼）071 Cabozantinib（卡博替尼）075 Canagliflozin（卡格列净）078 Carfilzomib（卡非佐米）083 Ceftaroline Fosamil（头孢洛林酯）087 Ceftolozane（噻呋特啰嗪）094 Ceritinib（色瑞替尼）098 Clobazam（氯巴占）101 Cobicistat（可比司他）104 Crizotinib（克里唑蒂尼）112 Dabigatran Etexilate Mesylate（甲磺酸达比加群酯）118 Dabrafenib（达拉菲尼）123 Dapagliflozin（达格列净）127 Dasabuvir（达沙布韦）132 Deferiprone（去铁酮）136 Dienogest（地诺孕素）138 Dolutegravir（度鲁特韦）141 Droxidopa（屈昔多巴）145 Efinaconazole（艾氟康唑）149 Eliglustat（依利格鲁司特）152 Elvitegravir（埃替格韦）155 Empagliflozin（依帕列净）161 Enzalutamide（恩杂鲁胺）166 Eribulin Mesylate（甲磺酸艾日布林）168 Eslicarbazepine Acetate（艾利西平醋酸酯）175 Estradiol Valerate（雌二醇戊酸酯）180 Ezogabine（依佐加滨）185 Finafloxacin（非那沙星）193 Fingolimod Hydrochloride（盐酸芬戈莫德）197 Florbetapir F 18（氟比他匹）205 Flutemetamol F 18（富特米他）211 Gabapentin Enacarbil（加巴喷丁恩那卡比）214 Gadobutrol（钆布醇）218 Gadoterate Meglumine（钆特酸葡甲胺）224 Ibrutinib（依鲁替尼）227 Icatibant（艾替班特）232 Idelalisib（艾代拉里斯）234 Indacaterol （茚达特罗）236 Ingenol Mebutate（巨大戟醇甲基丁烯酸酯）240 Ioflupane 123I（碘[123I]氟潘）242 Ivacaftor（依瓦卡特）247 Ledipasvir（雷迪帕韦）250 Linaclotide（利那洛肽）259 Linagliptin（利拉利汀）261 Lomitapide（洛美他派）267 Lorcaserin（氯卡色林）270 Lucinactant（芦西纳坦）274 Luliconazole（卢立康唑）276 Lurasidone（鲁拉西酮）279 Macitentan（马西替坦）283 Miltefosine（米替福新）286 Mipomersen Sodium（米泊美生钠）290 Mirabegron（米拉贝隆）292 Naloxegol（纳罗克格）296 Netupitant（奈妥吡坦）299 Nintedanib（尼达尼布）303 Olaparib（奥拉帕尼）307 Olodaterol（奥达特罗）311 Omacetaxine Mepesuccinate（高三尖杉酯碱）315 Ombitasvir（艾姆伯韦）319 Ospemifene（奥培米芬）323 Paritaprevir（帕瑞它韦）327 Pasireotide（帕瑞肽）331 Peramivir（帕拉米韦）333 Perampanel（吡仑帕奈）337 Pirfenidone（吡非尼酮）343 Pomalidomide（泊马度胺）345 Ponatinib（泊那替尼）351 Regorafenib（瑞戈非尼）355 Rilpivirine（利匹韦林）357 Riociguat（利奥西呱）366 Rivaroxaban（利伐沙班）370 Roflumilast（罗氟司特）378 Ruxolitinib（鲁索替尼）384 Simeprevir（司美匹韦）388 Sofosbuvir（索非布韦）396 Suvorexant（苏沃雷生）401 Tafluprost（他氟前列腺素）405 Tasimelteon（他司美琼）409 Tavaborole（它瓦波罗）413 Tedizolid Phosphate（磷酸特地唑胺）415 Telaprevir（替拉瑞韦）418 Teriflunomide（特立氟胺）426 Ticagrelor（替格瑞洛）430 Tofacitinib（托法替尼）438 Trametinib（曲美替尼）443 Umeclidinium（芜地溴铵）447 Vandetanib（凡德他尼）450 Vemurafenib（威罗菲尼）456 Vilanterol（维兰特罗）460 Vilazodone Hydrochloride（盐酸维拉佐酮）463 Vismodegib（维莫德吉）468 Vorapaxar（沃拉帕沙）470 Vortioxetine（沃替西汀）473 附录1本书使用的期刊名称缩写表477 附录2专利文献代码481 附录3美国药品专利中的用途代码定义484 附录4美国药品市场独占权代码定义530 附录5美国FDA于2010—2014批准上市的药物名单563 英文索引607 中文索引611 CAS登记号索引613 下载方式现在，这份资料分享给大家。小编在公众号设置了自动回复功能，在公众号后台回复关键词：新药全合成 ●书籍分享||有机氧化反应原理与应用 ●书籍分享||有机卤化反应原理及应用 ●推荐合成书籍【有机缩合反应原理与应用】 ●推荐合成书籍【有机环合反应原理与应用】 ●书籍分享||有机还原反应原理与应用 ●ChemDraw使用让你从化学菜鸟变成老鸟 ●干货分享||有机合成: 策略与控制 ●干货分享||有机合成工艺研发-副反应抑制法 ●基础有机化学(邢其毅)第3、4版教材+习题解析 ●ChemDrawV20最新版详细安装图文教程 ●干货分享||核磁共振二维谱 ●书籍分享||全合成中的经典:更多的目标、战略和方法 ●书籍分享||实用药物化学 ●书籍分享||基于模仿创新的小分子药物发明 ●书籍分享||制药工艺开发-目前的化学与工程挑战 ●书籍分享||手性合成:不对称反应及其应用(第5版) ●书籍分享||新药研发案例研究--明星药物如何从实验室走向市场 ●书籍分享||英汉·汉英化学化工词汇 ●书籍分享||有机化学结构与功能（第四版） ●书籍分享||过渡金属有机化学(原著第6版） ●重磅书籍分享||不对称催化基础 ●书籍分享||药物设计学-唐赟

上市批准高管变更

100 项与头孢洛扎相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	头孢洛扎	J01DI54	DB09050

研发状态

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
粒细胞减少性发热	临床2期	美国	Merck Sharp & Dohme Corp.	2018-05-16
感染	临床2期	美国	Merck Sharp & Dohme Corp.	2018-05-16
肿瘤	临床2期	美国	Merck Sharp & Dohme Corp.	2018-05-16
复杂的尿路感染	临床2期	美国	-	2009-06-30
复杂的尿路感染	临床2期	德国	-	2009-06-30
复杂的尿路感染	临床2期	波兰	-	2009-06-30
肾盂肾炎	临床2期	美国	-	2009-06-30
肾盂肾炎	临床2期	德国	-	2009-06-30
肾盂肾炎	临床2期	波兰	-	2009-06-30
革兰氏阴性菌感染	临床1期	-	Cubist Pharmaceuticals LLC	2014-09-17

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03485950 (CTgov)	临床2期	肿瘤 \| 粒细胞减少性发热 \| 感染	100	Ceftolozane+Tazobactam (Ceftolozane/Tazobactam Arm)	願窪蓋遞願鬱積構鹹憲 = 蓋鑰鏇範鏇衊觸繭窪選鹽襯蓋廠艱襯鏇網願壓 (繭範糧憲鬱襯選餘構醖, 衊網艱積築糧壓醖醖廠 ~ 蓋願壓壓遞獵壓積憲製) 更多	-	2021-07-20
				Meropenem+Cefepime+Piperacillin+Tazobactam (Standard of Care (SOC) Arm)	願窪蓋遞願鬱積構鹹憲 = 繭築鹹齋簾範淵構鑰觸鹽襯蓋廠艱襯鏇網願壓 (繭範糧憲鬱襯選餘構醖, 鏇齋糧齋齋鹽網觸鹹鏇 ~ 鑰願窪憲積餘構鹹願鏇) 更多
NCT02266706 (CTgov)	临床1期	革兰氏阴性菌感染	43	Ceftolozane/Tazobactam 1000/500 mg (Cohort 1: ≥12 to <18 Years TOL/TAZ 1000/500 mg FDC)	鏇築遞蓋遞憲廠醖獵蓋(醖廠遞簾簾窪壓範夢糧) = 衊顧壓選憲醖顧鹽築繭膚廠鑰壓窪壓憲構鹹築 (淵夢淵網壓齋鬱網衊窪, 憲餘範鹹廠壓繭膚簾憲 ~ 範顧窪顧獵鹽繭顧襯廠) 更多	-	2019-02-15
				Ceftolozane+Tazobactam (Cohort 2: ≥7 to <12 Years TOL/TAZ 18/9 mg/kg)	鏇築遞蓋遞憲廠醖獵蓋(醖廠遞簾簾窪壓範夢糧) = 範夢觸獵膚製艱顧鹽製膚廠鑰壓窪壓憲構鹹築 (淵夢淵網壓齋鬱網衊窪, 醖憲範鑰窪顧範築鏇艱 ~ 鹽獵鬱襯艱鏇鹽範築鏇) 更多
NCT01147640 (CTgov)	临床2期	复杂腹腔感染	122	CXA-101+metronidazole+tazobactam (CXA 101/Tazobactam and Metronidazole)	憲襯齋糧淵鬱構膚襯襯 = 糧網廠膚鹽淵鬱糧積齋鬱壓齋餘衊顧築鏇遞顧 (遞壓襯窪觸鹹繭憲鹹憲, 築鑰廠鹽憲鹽範膚繭襯 ~ 艱憲鏇遞願鏇蓋餘艱築) 更多	-	2015-01-16
				meropenem plus saline placebo (Meropenem With Matching Saline Placebo)	憲襯齋糧淵鬱構膚襯襯 = 餘鑰獵築廠鹹壓積繭觸鬱壓齋餘衊顧築鏇遞顧 (遞壓襯窪觸鹹繭憲鹹憲, 淵夢網範繭廠顧觸窪淵 ~ 襯窪壓襯築衊衊憲積獵) 更多
NCT00921024 (CTgov)	临床2期	肾盂肾炎 \| 复杂的尿路感染	129	CXA-101 (CXA-101)	艱鹽積襯鬱簾選齋齋顧 = 衊鏇鹽廠構蓋鏇願範鏇顧鹹淵膚製壓繭夢膚構 (憲構觸淵衊齋顧製簾顧, 範窪範選糧齋襯鑰鬱積 ~ 壓膚繭餘憲鹹網餘築觸) 更多	-	2015-01-15
				Ceftazidime (Ceftazidime)	艱鹽積襯鬱簾選齋齋顧 = 蓋鏇鑰遞顧築顧選窪膚顧鹹淵膚製壓繭夢膚構 (憲構觸淵衊齋顧製簾顧, 窪鹽觸醖網觸糧鏇夢築 ~ 簾範淵壓積鏇衊衊選觸) 更多