地塞米松/哌拉西林/他唑巴坦(Dexamethasone/Piperacillin/Tazobactam) - 药物靶点：GR x β-lactamase_在研适应症：中耳炎_专利_临床

概要

基本信息

药物类型

小分子化药

别名

YH-1177

靶点

GR x β-lactamase

作用机制

GR激动剂(糖皮质激素受体激动剂)、β-lactamase抑制剂(β-内酰胺酶抑制剂)

治疗领域

耳鼻咽喉疾病

在研适应症

中耳炎

非在研适应症-

原研机构

Yuhan Corp.

在研机构

Yuhan Corp.

非在研机构-

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

结构

分子式C23H27N5NaO7S

InChIKeyHKKJNUJNRAREQR-IDYPWDAWSA-N

CAS号59703-84-3

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关联

5

项与地塞米松/哌拉西林/他唑巴坦相关的临床试验

NCT05981079 / Recruiting临床4期IIT

Model-based Dose Versus Empirical Dose of Piperacillin/Tazobactam in the Treatment of Late-onset Sepsis in Preterm Neonates: a Multicentre, Randomised, Open-label, Non-inferiority Study.

This study aims to compare the clinical outcomes, safety and PD target attainment of the model-based dose and empirical dose of piperacillin/tazobactam in the treatment of LOS in premature neonates, so as to optimize the piperacillin/tazobactam dose regimen.

开始日期2023-07-31

申办/合作机构

山东大学

[+4]

NCT04803422 / RecruitingN/A

Per Oral Versus Intravenous Postoperative Antibiotics After Surgery for Complicated Appendicitis: A Cluster Randomized Cluster Crossover Non-Inferiority Study.

The PIPA trial is a prospective, multicentre, cluster randomized cluster crossover non-inferiority study. We aim to test whether a three-day postoperative course of per oral antibiotics is non-inferior to a three-day postoperative course of intravenous antibiotics as standard care after laparoscopic surgery for complicated appendicitis in regards to the risk of postoperative intraabdominal abscess formation within 30-days

开始日期2021-05-01

申办/合作机构

Roskilde Sygehus

NL-OMON46163 / SuspendedN/A

An explorative study determining the hepatic cyst penetration of antibiotics (ciprofloxacin, co-trimoxazole, doxycycline and piperacillin/tazobactam) and factors affecting penetration. - PENTAC 2

开始日期2019-01-01

申办/合作机构

Radboud Universitair Medisch Centrum

100 项与地塞米松/哌拉西林/他唑巴坦相关的临床结果

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100 项与地塞米松/哌拉西林/他唑巴坦相关的转化医学

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100 项与地塞米松/哌拉西林/他唑巴坦相关的专利（医药）

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2

项与地塞米松/哌拉西林/他唑巴坦相关的文献（医药）

2014-12-01·BMC infectious diseases3区 · 医学

Polymerase chain reaction ribotyping of Clostridium difficileisolates in Qatar: a hospital-based study

3区 · 医学

ArticleOA

作者: Naser A Al-Ansari ; Sanjay H Doiphode ; Wedad S Hamdi ; Godwin Justus Wilson ; Asma A Al-Thani

BACKGROUND:

Clostridium difficile infection (CDI) is not generally reported to public health authorities in the Middle East and its true prevalence remains largely unknown. The aims of this study were to determine the prevalence of CDI and its associated ribotypes among C. difficile isolates in Qatar. Influence of age and correlation with other risk factors e.g. proton pump inhibitor use, antibiotic use, existence of chronic conditions, etc was also investigated for CDI positive patients.

METHODS:

A total of 1,532 patients with suspected CDI were recruited from two hospitals between 2011 and 2012. C. difficile was identified using glutamate dehydrogenase (GDH) lateral flow assay and toxins A and B Enzyme Immunoassay (EIA). The C. difficile positive samples were then cultured for PCR-ribotyping.

RESULTS:

122 of the 1,532 (7.9%) samples from individual patients were identified as C.difficile positive; and 79 of these were viably cultured (~65%). From these, 36 different PCR ribotypes were isolated, of which strains 258 (6 [7.6%]), 01/014/046 (5 [6.3%]), and 011/053/056/107 (4 [5%]) were the most prevalent. The prevalence of PCR-ribotype 027 was 1.3% (n = 1). An age of ≥65 years and treatment with proton pump inhibitors correlated with higher frequency of CDI. Treatment with third generation cephalosporins (50 [41%]) and piperacillin/tazobactam antibiotics (55 [45.1%]) was most frequently associated with CDI.

CONCLUSION:

The most common C. difficile ribotype identified in Qatar was 258, which is different from those found in North America, Europe and Asia. The prevalence of CDI was higher in Qatar than Europe; though comparable to other Middle Eastern countries. These findings underscore the importance of local surveillance to detect and control C. difficile infection.

Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia4区 · 医学

New evidence in severe pneumonia: imipenem/ cilastatin/relebactam

4区 · 医学

Review

作者: Alarcón, T ; Gómez-Punter, R M ; Ibáñez, A ; Girón, R M

Imipenem combined with beta-lactamase inhibitor relebactam (IMI/REL) has an extensive bactericidal activity against Gram-negative pathogens producing class A or class C beta-lactamases, not active against class B and class D. The phase 3 clinical trial (RESTORE-IMI-2), double-blind, randomized, evaluated IMI/REL vs. piperacillin-tazobactam (PIP/TAZ) for treatment of hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP), demonstrated non-inferiority at all-cause mortality at 28 days (15.9% vs 21.3%), favorable clinical response at 7-14 days end of treatment (61% vs 59.8%) and with minor serious adverse effects (26.7% vs 32%). IMI/REL is a therapeutic option in HAP and VAP at approved dosage imipenem 500 mg, cilastatin 500 mg and relebactam 250 mg once every 6h, by an IV infusion over 30 min.

1

项与地塞米松/哌拉西林/他唑巴坦相关的新闻（医药）

2024-02-02

·药明康德

2月4款创新药有望获FDA批准

根据PDUFA的预期目标日期，预计2月，美国FDA将对4款创新药物的批准做出监管决定，本文将对这些疗法进行相关介绍。活性成分：Taniborbactam 适应症：复杂性尿路感染公司名称：Venatorx Pharmaceuticals Venatorx Pharmaceuticals公司开发的taniborbactam是一种β-内酰胺酶抑制剂（BLI），与第四代头孢菌素头孢吡肟联用，可降低细菌对头孢吡肟的耐药性。头孢吡肟/taniborbactam已被美国FDA授予合格传染病产品（QIDP）和快速通道资格。值得一提的是，中国的云顶新耀公司已与Venatorx达成研发合作，共同开发头孢吡肟/taniborbactam。去年8月，该公司宣布，美国FDA已接受为由头孢吡肟和taniborbactam构成的组合疗法递交的新药申请（NDA），用于治疗复杂性尿路感染（包括急性肾盂肾炎）成人患者。FDA同时授予这一申请优先审评资格，预计在今年2月22日之前给出审评结果。这一NDA得到关键性3期临床试验CERTAIN-1结果的支持。试验结果显示，头孢吡肟/taniborbactam达到了试验的主要终点，与活性对照组相比，达到统计学非劣效性标准。头孢吡肟/taniborbactam组70.0%的患者达到临床和微生物学应答（细菌根除）的复合终点，活性对照组这一数值为58%。在达到非劣效性主要终点后的预定优效性分析显示头孢吡肟/taniborbactam组合表现出统计学优效性。活性成分：Lifileucel 适应症：黑色素瘤公司名称：Iovance Biotherapeutics Lifileucel是基于患者自身的肿瘤浸润淋巴细胞（TIL）构建的细胞疗法，这些TIL在癌症发生时会迁移到肿瘤处并且对肿瘤发起攻击。然而，通常患者体内的TIL数目不足以消灭肿瘤，而且肿瘤微环境会抑制TIL的功能。这款疗法通过从患者体内获取肿瘤组织并且提取TIL，然后在体外使用IL-2细胞因子以刺激TIL的扩增。这一体外刺激手段不但增加了TIL的数量，还能激活TIL的抗肿瘤能力。然后这些TIL被注回患者体内，更有效地杀伤肿瘤细胞。去年5月，Iovance Biotherapeutics公司宣布，FDA已接受lifileucel用于治疗晚期黑色素瘤患者的生物制品许可申请（BLA），并授予其优先审评资格。此次BLA申请得到了C-144-01临床试验积极结果的支持，该试验针对先前在抗PD-1/L1治疗和靶向治疗（如适用）期间或之后出现疾病进展的晚期黑色素瘤患者。试验结果表明，一次性注射lifileucel，能够在接受过PD-1抑制剂和BRAF/MEK靶向疗法的难治性患者中，达到34.3%的总缓解率。如果lifileucel获得加速批准，那么3期临床试验TILVANCE-301可作为支持完全批准的验证性研究。Iovance预计在FDA批准之时，TILVANCE-301试验已经顺利开展。活性成分：Roluperidone 适应症：精神分裂症公司名称：Minerva Neurosciences Roluperidone是一种在研小分子拮抗剂，开发用以治疗精神分裂症的阴性症状。该疗法已被证明可以阻断血清素、sigma和α-肾上腺素能受体，这些受体都参与调节重要的大脑功能，包括情绪、认知、睡眠和焦虑。Roluperidone旨在避免直接阻断多巴胺能受体（第一代和第二代抗精神病药的关键药理学靶点），同时保持对血清素受体的特定亚型5-HT2A（第二代抗精神病药的另一个关键靶点）以及其他药理学靶点（sigma2和肾上腺素-α1A）的阻断。去年5月，Minerva Neurosciences公司宣布美国FDA已接受为roluperidone递交的NDA，用于治疗精神分裂症患者的症状（包括难以享受生活、脱离人群等）。预计在今年2月26日之前做出审评决定。活性成分：Enmetazobactam 适应症：复杂性尿路感染公司名称：Allecra Therapeutics Enmetazobacta是Allecra公司开发的β-内酰胺酶抑制剂。与头孢吡肟联用，旨在对抗革兰氏阴性菌的耐药性，尤其是由β-内酰胺酶介导的超广谱耐药性。Enmetazobacta/头孢吡肟组合已经获得美国FDA授予的合格传染病产品资格（QIDP）。去年6月，Allecra公司宣布已经向美国FDA递交头孢吡肟/enmetazobactam组合的新药申请，用于治疗复杂性尿路感染。此次NDA的提交得到了一项随机双盲、含活性对照的3期试验ALLIUM结果的支持，该试验在复杂性尿路感染患者中研究了头孢吡肟/enmetazobacta与哌拉西林/他唑巴坦（当前标准治疗）相比的疗效。在临床治愈和微生物学根除的主要复合终点方面，与哌拉西林/他唑巴坦相比，头孢吡肟/enmetazobacta达到非劣效性和优效性标准。今年1月，Allecra Therapeutics的合作伙伴Advanz Pharma宣布，欧洲药品管理局（EMA）人用药品委员会（CHMP）已发表了积极意见，推荐批准这款抗生素组合在欧盟上市。参考资料： [1] Venatorx Pharmaceuticals Announces FDA Acceptance and Priority Review of New Drug Application for Cefepime-Taniborbactam to Treat Complicated Urinary Tract Infections (cUTI), including Pyelonephritis, in Adults. Retrieved January 31, 2024, from https://venatorx.com/press-releases/venatorx-pharmaceuticals-announces-fda-acceptance-and-priority-review-of-new-drug-application-for-cefepime-taniborbactam-to-treat-complicated-urinary-tract-infections-cuti-including-pyelonephritis/ [2] Minerva Neurosciences Announces Update on its New Drug Application (NDA) for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia. Retrieved January 31, 2024, from https://ir.minervaneurosciences.com/news-releases/news-release-details/minerva-neurosciences-announces-update-its-new-drug-0 内容来源于网络，如有侵权，请联系删除。

优先审批快速通道临床结果合格传染病产品

100 项与地塞米松/哌拉西林/他唑巴坦相关的药物交易

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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
中耳炎	临床2期	韩国	Yuhan Corp.	2016-06-01

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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


EASL2020	N/A	自发性细菌性腹膜炎	-	Piperacillin/tazobactam (PTZ)	鹹製遞積鹽構網窪構艱(齋積衊範衊鬱淵鑰鏇鑰) = 製鹽鹹膚醖顧廠醖顧膚簾醖鏇襯鑰糧鑰齋鹽醖 (膚觸選艱蓋觸製鏇選網 ) 更多	-	2020-08-27
				Piperacillin/tazobactam (PTZ) + Linezolid (LZD)	鹹製遞積鹽構網窪構艱(齋積衊範衊鬱淵鑰鏇鑰) = 繭淵鹽艱夢範鏇襯築願簾醖鏇襯鑰糧鑰齋鹽醖 (膚觸選艱蓋觸製鏇選網 ) 更多
ERS2019	N/A	肺炎	43	Cefepime with Ciprofloxacin	積構膚觸膚淵廠膚繭餘(醖鏇顧遞遞糧窪壓築選) = 鏇鹹憲構顧積艱鏇範築廠觸顧餘願網夢艱鑰積 (繭遞糧襯壓廠鑰壓積餘 ) 更多	-	2019-09-28
				Piperacillin/tazobactam with Ciprofloxacin	積構膚觸膚淵廠膚繭餘(醖鏇顧遞遞糧窪壓築選) = 願壓鏇齋製獵夢鑰憲積廠觸顧餘願網夢艱鑰積 (繭遞糧襯壓廠鑰壓積餘 ) 更多
Pubmed \| Pharmacotherapy	N/A	危重病	367	Extended-infusion (EI) piperacillin/tazobactam	簾齋築襯廠夢夢艱繭齋(顧遞鹽遞鹹鑰網築淵鏇) = 鏇糧齋鹹廠淵膚鹽蓋鹹鏇觸夢憲憲齋願願網齋 (壓觸顧範憲鏇壓願蓋鬱 ) 更多	-	2017-01-01
				Non-extended infusion (NEI) piperacillin/tazobactam	簾齋築襯廠夢夢艱繭齋(顧遞鹽遞鹹鑰網築淵鏇) = 網網製繭鬱遞鹹鬱顧鏇鏇觸夢憲憲齋願願網齋 (壓觸顧範憲鏇壓願蓋鬱 ) 更多