Aminoglycosides in Early Sepsis (AGES): A Randomized Pragmatic Clinical Trial Comparing Gentamicin and Narrow Spectrum Betalactams to Broad Spectrum Betalactams as Empirical Treatment in Patients With Suspected Sepsis

Norwegian guidelines for empirical antibiotic therapy in suspected community acquired sepsis recommend the combination of narrow spectrum betalactam and aminoglycoside as the first choice, but broad spectrum betalactams are considered equally appropriate, effective, and safe. However, fear of renal complications due to gentamicin and concern for lacking evidence for efficiency commonly leads to the use of broad spectrum betalactam therapy, a larger driver of antibiotic resistance.
In patients with suspected community acquired sepsis, the investigators hypothesize that empirical combination therapy with narrow spectrum betalactams and aminoglycosides is safe and non-inferior to empirical therapy with broad spectrum betalactams. More specifically, the investigators hypothesize that the proportion of patients with acute kidney injury or death will be similar between these two treatment groups. Furthermore, the investigators hypothesize that the aminoglycoside-based regimen has lesser impact on the gut microbiome. Antimicrobial resistance is one of the most urgent health threats of our time, and Norwegian hospitals were required but failed to reduce the use of broad-spectrum antibiotics with 30% by the end of 2020. In this context, novel initiatives aiming at reducing use of antibiotics are direly needed.

开始日期2025-10-01

申办/合作机构

Akershus Universitetssykehus HF

[+1]

NCT06954129

/ Not yet recruiting临床4期IIT

Markers of Nephrotoxicity During Treatment With Antibiotic Combinations: A Pragmatic Clinical Trial

Hospitalized patients with suspected or confirmed infection are commonly treated with vancomycin (VN) in combination with either piperacillin-tazobactam (PT) or cefepime (CP). Although these regimens have similar effectiveness, recent observational evidence suggests they may differ in terms of the risk for acute kidney injury (AKI). Interpretation of existing evidence is complicated by the limitations of creatinine, the standard biomarker used to monitor kidney function, which has poor sensitivity and specificity for drug induced AKI. To address this important knowledge gap, the investigators propose to conduct a pragmatic, open-label, non-inferiority trial that will examine the comparative risk of AKI between these standard-of-care antibiotic combinations using sensitive and specific markers of drug-induced AKI. We hypothesize that the regimen of VN in combination with PT (VN+PT) is noninferior to the regimen of VN in combination with CP (VN+CP) in terms of AKI risk.

开始日期2025-10-01

申办/合作机构

University of Pennsylvania

ChiCTR2500109407

/ Recruiting早期临床1期IIT

A multicenter, prospective, randomized controlled trial evaluating β-lactam combined with omadacycline for the treatment of severe community-acquired pneumonia.

开始日期2025-09-01

申办/合作机构-

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100 项与哌拉西林钠他唑巴坦钠相关的专利（医药）

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4,635

项与哌拉西林钠他唑巴坦钠相关的文献（医药）

2026-01-01·FOOD MICROBIOLOGY

Population structure of Bacillus cereus sensu lato associated with foodborne outbreaks in France between 2004 and 2023

Article

作者: Firmesse, Olivier ; Bonis, Mathilde ; Pairaud, Sylvie ; Mozhaitseva, Ksenia

Bacillus cereus sensu lato (Bcsl) is a group of closely related bacterial species known for their resistant spores, enabling them to persist in a dormant state and thereby colonize and adapt across diverse environments. Bcsl is known for its harmful impact on human health, producing toxins that cause emetic and diarrheal syndromes or provoking extradigestive infections. Importantly, Bcsl is the most frequent confirmed or presumptive causative agent associated with foodborne outbreaks (FBOs) in France. In our study, we assessed the population structure of a large collection of Bcsl isolated during FBOs investigation in France between 2004 and 2023, focusing on the association between distinct populations and food categories. Using 294 genomes from 183 FBOs, we applied genomic clustering and phylogenomic analysis and then identified three predominant Bcsl populations. B. cereus sensu stricto (17.0 %) prevailed in composite dishes, B. paranthracis (16.1 %) was positively associated with cereals, and B. thuringiensis subsp. kurstaki (7.6 %) was predominantly found in vegetable-based salads. Some strains were phylogenetically closely related to clinical isolates, highlighting the need to assess the antibiotic susceptibility of Bcsl. Notably, one Bcsl clade, B. cytotoxicus, lacking beta-lactamase-encoding genes showed a greatly increased sensitivity to ampicillin than other Bcsl considered to be naturally resistant to beta-lactams. Additionally, various strains from distinct populations showed reduced susceptibility to macrolides and cyclins. Finally, accurately differentiated populations will be used in further epidemiological studies and in dose-response modeling.

2025-12-01·JOURNAL OF CRITICAL CARE

Major publications in the critical care pharmacotherapy literature: 2024

Review

作者: Brown, Sophia ; Murray, Brian ; Li, Ji ; Farrar, Julie ; Roginski, Matthew A ; Bernardoni, Brittney ; Filiberto, Dina M ; Thompson, Tori R ; Perrodin, Jenna S ; Kopp, Brian J ; Madorsky, Melanie ; Esteves, Alyson M ; Tallon, Joanna K ; Moore, Megan J

OBJECTIVES:

To summarize, analyze, and provide clinical insights on the most impactful publications related to critical care pharmacotherapy in 2024.

METHODS:

A systematic search of PubMed/Medical Literature Analysis and Retrieval System Online (MEDLINE) was conducted between January 1, 2024, and December 31, 2024. Randomized controlled trials, prospective study designs, or retrospective study designs with high-quality methodology of adult critically ill patients assessing a pharmacotherapeutic intervention and reporting clinical endpoints were considered for inclusion. An a priori defined three-round modified Delphi process was performed to achieve consensus from a multi-disciplinary and geographically diverse group of critical care clinicians, focusing on the publications deemed most impactful based on their overall contribution to scientific knowledge and novelty.

RESULTS:

The systematic search yielded a total of 1533 articles, of which 1492 were excluded. Forty-one articles were included in the modified Delphi process. In each round, articles were independently scored based on their overall contribution to scientific knowledge and novelty and articles achieving a score at or above the median proceeded to the next round of voting. The six included articles are summarized and their impact is discussed. Article topics included cessation of proton pump inhibitors during transitions of care, stress ulcer prophylaxis in mechanically ventilated patients, continuous infusion beta-lactams in sepsis, ceftriaxone for prevention of ventilator-associated pneumonia, optimal antibiotic duration for bloodstream infections, and andexanet alfa for management of intracranial hemorrhage associated with factor Xa inhibitors.

CONCLUSIONS:

This review identified, summarized, and evaluated high impact studies relevant to critical care pharmacotherapy published in 2024.

2025-12-01·One Health

Unveiling the prevalence and antimicrobial resistance landscape of Pantoea genus in veterinary clinical strains: Insights from a cohort study

Article

作者: Caneiras, Cátia ; Bzdil, Jaroslav ; Sladecek, Vladimir ; Holy, Ondrej ; Zouharova, Monika ; Parra-Flores, Julio

The genus Pantoea, of which Pantoea agglomerans is the most common species, is an emerging Gram-negative facultative anaerobic bacillus that causes a wide range of opportunistic infections. To date, the prevalence, antibiotic resistance, and pathogenic potential of this bacterium in animals remains largely unexplored. The aim of this work was to describe the prevalence of microorganisms of the genus Pantoea in clinical samples obtained from animals during the period 2015-2017 and to define their susceptibility to antimicrobial agents. In the monitored period, a total of 23,739 clinical samples obtained from animals in the Czech Republic with symptoms of disease were tested, from which 151 Pantoea genus were isolated (prevalence 0.63 %). Cultivation and incubation were carried out under aerobic conditions by culture methods using massopeptone blood agar, Endo's agar and xylose lysine deoxycholate agar at 37 ± 1 °C for 24 h. Suspect strains were confirmed by matrix-assisted laser desorption/ionization coupled to time-of-flight mass spectrometry (MALDI-TOF MS). Susceptibility testing was performed by the standard disk diffusion method using Mueller-Hinton agar. Pantoea strains were recovered from domestic horses, carnivores (dogs, cats) and rodents (prevalence of 6.78, 1.64 and 1.12 % respectively). Resistance to beta-lactam antimicrobials was detected in 12 strains. In addition to beta-lactams, resistance to co-trimoxazole was detected in 1 case and to co-trimoxazole and chloramphenicol in 1 case, highlights the need to monitor the emergence of this strain in the context of the One Health approach.

181

项与哌拉西林钠他唑巴坦钠相关的新闻（医药）

2025-11-13

·国家药品监督管理局

2025年11月13日药品批准证明文件送达信息

2022年11月1日起，行政相对人可登录国家药品监督管理局政务服务门户的法人空间查看电子证照，按照相关提示自行打印。序号受理号药品名称申请人批准文号批准日期1CYHB2401488单唾液酸四己糖神经节苷脂钠注射液齐鲁制药有限公司————2025年11月11日2CYHB2401489单唾液酸四己糖神经节苷脂钠注射液齐鲁制药有限公司————2025年11月11日3CYHB2401490单唾液酸四己糖神经节苷脂钠注射液齐鲁制药有限公司————2025年11月11日4CYHB2401517注射用哌拉西林钠他唑巴坦钠山东安信制药有限公司————2025年11月07日5CYHB2401518注射用哌拉西林钠他唑巴坦钠山东安信制药有限公司————2025年11月07日6CYHB2450406注射用醋酸卡泊芬净四川制药制剂有限公司————2025年11月10日7CYHB2450407注射用醋酸卡泊芬净四川制药制剂有限公司国药准字H202582482025年11月10日8CYHB2501526达格列净片河北智恒医药科技股份有限公司————2025年11月11日9CYHB2501622恩格列净片合肥国高药业有限公司————2025年11月11日10CYHB2501957双嘧达莫片吉林省祈克药业有限公司————2025年11月11日11CYHB2502077复方岩白菜素片湖南诺纳医药科技有限公司————2025年11月11日12CYHB2502085牡蛎碳酸钙片吉林省祈克药业有限公司————2025年11月11日13CYHB2502092瑞香素胶囊吉林省祈克药业有限公司————2025年11月11日14CYHB2502103牛磺酸滴眼液吉林省祈克药业有限公司————2025年11月11日15CYHB2502106罗红霉素胶囊吉林省祈克药业有限公司————2025年11月11日16CYHB2502107罗红霉素胶囊吉林省祈克药业有限公司————2025年11月11日17CYHB2502108罗红霉素胶囊吉林省祈克药业有限公司————2025年11月11日18CYHB2502120骨肽注射液吉林省祈克药业有限公司————2025年11月11日19CYHB2502121盐酸艾司洛尔注射液重庆安诺生生命科技有限公司————2025年11月11日20CYHB2502122骨肽注射液吉林省祈克药业有限公司————2025年11月11日21CYHB2502130阿昔洛韦滴眼液吉林省祈克药业有限公司————2025年11月11日22CYHB2502131诺氟沙星滴眼液吉林省祈克药业有限公司————2025年11月11日23CYHB2502132利巴韦林滴眼液吉林省祈克药业有限公司————2025年11月11日24CYHB2502136乳酶生片吉林省祈克药业有限公司————2025年11月11日25CYHB2502137利巴韦林含片吉林省祈克药业有限公司————2025年11月11日26CYHB2550080注射用美罗培南海口市制药厂有限公司————2025年11月06日27CYHB2550081注射用美罗培南海口市制药厂有限公司————2025年11月06日28CYHB2550082注射用美罗培南海口市制药厂有限公司————2025年11月06日29CYSB2500071人纤维蛋白原上海莱士血液制品股份有限公司————2025年11月11日30CYSB2500161无细胞百白破b型流感嗜血杆菌联合疫苗北京民海生物科技有限公司————2025年11月11日31CYSB2500162吸附无细胞百白破联合疫苗北京民海生物科技有限公司————2025年11月11日32CYSB2500164b型流感嗜血杆菌结合疫苗北京民海生物科技有限公司————2025年11月11日33CYSB2500165b型流感嗜血杆菌结合疫苗北京民海生物科技有限公司————2025年11月11日34CYZB2502292强腰壮骨膏湖南九典制药股份有限公司————2025年11月06日35CYZB2502323肾石通颗粒湖南诺纳医药科技有限公司————2025年11月11日36CYZB2502324清火片湖南诺纳医药科技有限公司————2025年11月11日37CYZB2502325三胶颗粒湖南诺纳医药科技有限公司————2025年11月11日38CYZB2502326史国公药酒湖南诺纳医药科技有限公司————2025年11月11日39CYZB2502332杞菊地黄口服液天方药业有限公司————2025年11月11日40CYZB2502334大山楂颗粒天方药业有限公司————2025年11月11日41CYZB2502335代温灸膏湖南诺纳医药科技有限公司————2025年11月11日42CYZB2502336参苓健体粉湖南诺纳医药科技有限公司————2025年11月11日43CYZB2502346大山楂丸通化斯威药业股份有限公司————2025年11月11日44CYZB2502348咽炎片杨凌科森生物制药有限责任公司————2025年11月11日45CYZB2502349咽炎片杨凌科森生物制药有限责任公司————2025年11月11日46CYZB2502350消淋败毒散山东步长制药股份有限公司————2025年11月11日47JTH2500154瑞戈非尼片拜耳医药保健有限公司————2025年11月11日48JYHB2500484枸橼酸托法替布缓释片辉瑞投资有限公司————2025年11月11日49JYSB2400223司美格鲁肽注射液诺和诺德（中国）制药有限公司————2025年11月11日

申请上市临床申请

2025-11-11

·国家药品监督管理局

2025年11月11日药品批准证明文件送达信息

2022年11月1日起，行政相对人可登录国家药品监督管理局政务服务门户的法人空间查看电子证照，按照相关提示自行打印。序号受理号药品名称申请人批准文号批准日期1CYHB2400370磷酸川芎嗪注射液(供静脉注射用)山东益健药业有限公司————2025年11月10日2CYHB2401516注射用哌拉西林钠他唑巴坦钠山东安信制药有限公司————2025年11月07日3CYHB2450537多索茶碱片浙江昂利康制药股份有限公司国药准字H202582472025年11月07日4CYHB2450538多索茶碱片浙江昂利康制药股份有限公司————2025年11月07日5CYHB2500010氯化钾颗粒重庆药谷制药有限公司————2025年11月07日6CYHB2500011氯化钾颗粒重庆药谷制药有限公司————2025年11月07日7CYHB2500152甲硝唑氯化钠注射液广东科泓药业有限公司————2025年11月10日8CYHB2500180氧庆阳市千宁气体有限公司————2025年11月10日9CYHB2501229口服补液盐散（Ⅲ）成都恒瑞制药有限公司————2025年11月07日10CYHB2501332复方多黏菌素B软膏浙江孚诺医药股份有限公司————2025年11月10日11CYHB2501424舒沃替尼片迪哲（江苏）医药股份有限公司————2025年11月10日12CYHB2501425舒沃替尼片迪哲（江苏）医药股份有限公司————2025年11月10日13CYHB2501587氨酚曲马多片西安杨森制药有限公司————2025年11月07日14CYHB2501593葡萄糖氯化钠注射液成都青山利康药业股份有限公司————2025年11月10日15CYHB2501594葡萄糖氯化钠注射液成都青山利康药业股份有限公司————2025年11月10日16CYHB2501595葡萄糖氯化钠注射液成都青山利康药业股份有限公司————2025年11月10日17CYHB2501600注射用还原型谷胱甘肽瑞阳制药股份有限公司————2025年11月10日18CYHB2501652单硝酸异山梨酯缓释片西藏诺迪康科技发展有限公司————2025年11月10日19CYHB2501653单硝酸异山梨酯缓释片西藏诺迪康科技发展有限公司————2025年11月10日20CYHB2501688盐酸拉贝洛尔注射液南京斯泰尔医药科技有限公司————2025年11月10日21CYHB2501784盐酸伐昔洛韦片安士制药（中山）有限公司————2025年11月10日22CYHB2502037对乙酰氨基酚注射液广东星昊药业有限公司————2025年11月07日23CYHB2502048托吡卡胺滴眼液吉林省祈克药业有限公司————2025年11月07日24CYHB2502049托吡卡胺滴眼液吉林省祈克药业有限公司————2025年11月07日25CYHB2502050盐酸雷尼替丁胶囊吉林省祈克药业有限公司————2025年11月07日26CYHB2502082利福平片吉林省祈克药业有限公司————2025年11月07日27CYHB2502083氯霉素片吉林省祈克药业有限公司————2025年11月07日28CYHB2502102乳酶生片吉林省祈克药业有限公司————2025年11月07日29CYHB2502104吡拉西坦片吉林省祈克药业有限公司————2025年11月07日30CYHB2502109吉他霉素片吉林省祈克药业有限公司————2025年11月07日31CYHB2502110氯芬黄敏片吉林省祈克药业有限公司————2025年11月07日32CYHB2502113双氯芬酸钠肠溶片吉林省祈克药业有限公司————2025年11月07日33CYHB2502147羧甲司坦片黑龙江君安药业集团鸿祥制药有限公司————2025年11月07日34CYHB2502223他克莫司软膏武汉江承医药科技有限公司————2025年11月07日35CYHB2502224他克莫司软膏武汉江承医药科技有限公司————2025年11月07日36CYSB2400190猪纤维蛋白粘合剂上海利康瑞生物工程有限公司国药准字S202580212025年11月07日37CYSB2400266司普奇拜单抗注射液成都康诺行生物医药科技有限公司国药准字S202580222025年11月07日38CYSB2500022贝伐珠单抗注射液齐鲁制药有限公司————2025年11月07日39CYSB2500160冻干人用狂犬病疫苗（人二倍体细胞）北京民海生物科技有限公司————2025年11月07日40CYZB2502297夏枯草片雅安迅康药业有限公司————2025年11月07日41CYZB2502302脉舒平袋泡茶内蒙古五疗堂药品技术开发有限公司————2025年11月07日42CYZB2502306痰咳净片修正药业集团天汉药业有限公司————2025年11月07日43CYZB2502307感冒灵胶囊修正药业集团天汉药业有限公司————2025年11月07日44CYZB2502331乳泉颗粒天方药业有限公司————2025年11月07日45CYZB2502333产妇安颗粒天方药业有限公司————2025年11月07日46JTH2500153丁丙诺啡-N-氧化物萌蒂（中国）制药有限公司————2025年11月07日47JYHB2500020脂肪乳氨基酸(17)葡萄糖(11%)注射液费森尤斯卡比华瑞制药有限公司————2025年11月07日48JYHB2500021脂肪乳氨基酸(17)葡萄糖(11%)注射液费森尤斯卡比华瑞制药有限公司————2025年11月07日49JYHB2500022脂肪乳氨基酸(17)葡萄糖(11%)注射液费森尤斯卡比华瑞制药有限公司————2025年11月07日50JYHB2500023脂肪乳氨基酸(17)葡萄糖(11%)注射液费森尤斯卡比华瑞制药有限公司————2025年11月07日51JYHB2500024脂肪乳氨基酸(17)葡萄糖(11%)注射液费森尤斯卡比华瑞制药有限公司————2025年11月07日52JYHB2500418注射用舒巴坦钠/注射用度洛巴坦钠组合包装再鼎医药（上海）有限公司————2025年11月10日53JYHB2500424糠酸氟替卡松鼻用喷雾剂葛兰素史克（中国）投资有限公司————2025年11月10日54JYHB2500431硝酸异山梨酯注射液珠海英联医药有限公司————2025年11月10日55JYHB2500432硝酸异山梨酯注射液珠海英联医药有限公司————2025年11月10日56JYHB2500468厄达替尼片西安杨森制药有限公司————2025年11月10日57JYHB2500469厄达替尼片西安杨森制药有限公司————2025年11月10日58JYHB2500470厄达替尼片西安杨森制药有限公司————2025年11月10日59JYHB2500472马来酸阿法替尼片勃林格殷格翰(中国)投资有限公司————2025年11月10日60JYHB2500473马来酸阿法替尼片勃林格殷格翰(中国)投资有限公司————2025年11月10日61JYHB2500483枸橼酸托法替布片辉瑞投资有限公司————2025年11月10日62JYHB2500559咪唑斯汀缓释片欧彼乐健康科技（上海）有限公司————2025年11月07日63JYHZ2500120瑞戈非尼片拜耳医药保健有限公司国药准字HJ201713002025年11月10日64JYHZ2500122阿奇霉素片梯瓦医药信息咨询（上海）有限公司国药准字HJ201602462025年11月10日65JYHZ2500123阿奇霉素片梯瓦医药信息咨询（上海）有限公司国药准字HJ201602472025年11月10日66JYHZ2500126咪康唑口腔贴片赛生医药（中国）有限公司国药准字HJ202000652025年11月10日67JYHZ2500130美阿沙坦钾片天津武田药品有限公司国药准字HJ202100032025年11月10日68JYHZ2500131美阿沙坦钾片天津武田药品有限公司国药准字HJ202100042025年11月10日69JYHZ2500132阿贝西利片礼来苏州制药有限公司国药准字HJ202000692025年11月10日70JYHZ2500133阿贝西利片礼来苏州制药有限公司国药准字HJ202000682025年11月10日71JYHZ2500134阿贝西利片礼来苏州制药有限公司国药准字HJ202000672025年11月10日72JYSB2500080注射用拉布立海赛诺菲（中国）投资有限公司————2025年11月07日73JYSB2500194乌司奴单抗注射液西安杨森制药有限公司————2025年11月07日74JYSB2500195乌司奴单抗注射液西安杨森制药有限公司————2025年11月07日75JYSB2500196乌司奴单抗注射液西安杨森制药有限公司————2025年11月07日

申请上市临床申请

2025-11-04

·Business Wire

Meitheal Pharmaceuticals Receives Approval from the US Food and Drug Administration for CONTEPO™ (fosfomycin) for injection in Patients ≥ 18 Years Having Complicated Urinary Tract Infections (cUTI), Including Acute Pyelonephritis (AP)

CHICAGO--(BUSINESS WIRE)--Meitheal Pharmaceuticals, Inc. (“Meitheal”), a fully integrated biopharmaceutical company based in Chicago and focused on the development and commercialization of generic injectables, fertility, biologic, and branded products, announced approval from the U.S. Food and Drug Administration (FDA) for CONTEPO (fosfomycin) for injection for the treatment of adult patients with complicated urinary tract infections (cUTI), including acute pyelonephritis, caused by susceptible isolates of Escherichia coli and Klebsiella pneumoniae. CONTEPO, an intravenous (IV) antibiotic that is an injectable epoxide and sole antibiotic class member, has demonstrated activity against gram-negative bacteria including Escherichia coli and Klebsiella pneumoniae that cause cUTIs.1,2 It has no known cross-resistance to other antibiotic classes.3,4 Targeting bacteria’s cell wall at an earlier stage than β-lactam antibiotics, CONTEPO’s unique mechanism of action inhibits the first committed step in bacterial cell wall synthesis, eliminating all downstream signaling that is vital to cell survival and leading to the destruction of the bacteria.2 “The escalating public health issue of antimicrobial resistance and emergence of highly resistant organisms demands immediate attention and innovative therapeutic solutions. The approval of CONTEPO is a major milestone in our company’s evolution and the fight against the ongoing threat of antibiotic resistance,” said Tom Shea, Chief Executive Officer of Meitheal Pharmaceuticals. “We are proud to add a second branded product to our growing portfolio of anti-infectives and antibiotics and look forward to delivering this high-quality and effective antibiotic medicine to patients and providers.” The FDA approval is supported by data from the pivotal Phase 2/3 ZEUS (ZTI-01) trial which investigated the safety and efficacy of the treatment on hospitalized patients with cUTI, including acute pyelonephritis. The trial showed that intravenous (IV) fosfomycin was noninferior to piperacillin/tazobactam for the primary efficacy endpoint—overall success, defined as clinical cure and microbiologic eradication—at the test-of-cure visit in the microbiological modified intent-to-treat (mMITT) population. Overall success was achieved in 63.5% (108/170) of patients receiving IV fosfomycin and 55.6% (94/169) of those receiving piperacillin/tazobactam, with a treatment difference of 7.9 (95% CI -3.1 to 18.9). The safety and tolerability profile of CONTEPO was generally well-tolerated.2 The most commonly reported adverse reactions in ≥2% of CONTEPO patients in the study included transaminase elevations (10.3%), hypokalemia (9.9%), neutropenia (6.4%), nausea (4.3%), diarrhea (3.9%), vomiting (3.9%), hypocalcemia (3.9%), hypernatremia (3.4%), headache (2.6%), and hypophosphatemia (2.1%). "The rise of multi-drug-resistant pathogens poses a significant threat to our ability to combat infectious diseases, underscoring the continued need for novel therapies that target resistant organisms in patients having cUTIs," said Dr. Keith S. Kaye, MD, MPH Chief, Division of Allergy, Immunology and Infectious Diseases at the Robert Wood Johnson Medical School. “With an estimated three million cases of cUTIs treated in the hospital setting annually, there is a critical need for a safe and effective treatment option.5 CONTEPO’s safety, efficacy, and novel mechanism of action makes it a favorable new treatment option,” said Dr. Keith Robinson, Chief Medical Officer of Meitheal Pharmaceuticals. With this approval, Meitheal’s portfolio has rapidly expanded to over 70 on-market products with additional generic launches expected before the end of the year across its core therapeutic areas of anti-infectives, anesthetics, critical care, fertility, and oncology. ABOUT CONTEPO CONTEPO (fosfomycin) for injection is a novel, intravenous antibiotic and is the only FDA approved epoxide antibacterial product. Part of a different class of antibiotics known as phosphonics, CONTEPO covalently binds and inhibits phosphoenolpyruvate transferase (MurA) which prevents the formation of cell wall precursors, blocks cell wall synthesis and leads to the destruction of bacteria. It has demonstrated activity against gram-negative bacteria including Escherichia coli and Klebsiella pneumoniae and other antimicrobial resistant pathogens. Efficacy and safety in patients have been demonstrated in adult patients with complicated urinary tract infections (cUTI), including acute pyelonephritis. INDICATIONS AND USAGE CONTEPO (fosfomycin) is indicated for the treatment of patients 18 years and older with complicated urinary tract infections (cUTI), including acute pyelonephritis, caused by susceptible isolates of Escherichia coli and Klebsiella pneumoniae. Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of CONTEPO and other antibacterial drugs, CONTEPO should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. IMPORTANT SAFETY INFORMATION Contraindications CONTEPO is contraindicated in patients with known serious hypersensitivity to fosfomycin, or any of the excipients. Warning and Precautions Serum Electrolyte Abnormalities: CONTEPO contains 1,980 mg of sodium in each vial. The high sodium load associated with the use of CONTEPO may result in changes in serum electrolytes, such as increased levels of serum sodium and decreased levels of potassium, calcium, and phosphorous. Electrolyte disturbances, such as hypokalemia and hypocalcemia, may potentiate cardiac effects, including QT prolongation. In a phase 2/3 comparator-controlled clinical trial in patients with cUTI, the following occurred more frequently in CONTEPO-treated patients compared with piperacillin/tazobactam-treated patients: hypokalemia (9.9%), hypernatremia (3.4%), hypophosphatemia (2.1%), and hypocalcemia (3.9%). Monitor serum electrolyte levels and fluid status during treatment with CONTEPO. Electrolyte supplementation may be necessary in some cases. Monitor for signs of edema, particularly in patients who should restrict their sodium intake or are prone to fluid overload. QT Prolongation: CONTEPO has been shown to prolong the QT interval in some patients. QT prolongation can lead to development of torsade de pointes-type ventricular tachycardia with the risk increasing as the degree of prolongation increases. The risk of QT prolongation may increase in patients with electrolyte abnormalities, or those that have conditions or take medications that may cause an electrolyte imbalance. Avoid CONTEPO in patients with known QT prolongation or ventricular arrhythmias, including a history of torsade de pointes. Monitor electrolytes during treatment with CONTEPO. Increase Transaminase Levels: In a phase 2/3 clinical trial, increases in transaminases occurred more frequently in CONTEPO-treated patients compared to piperacillin/tazobactam-treated patients. Transaminases (alanine aminotransferase (ALT) or aspartate aminotransferase (AST)) were elevated > 3x upper limit of normal (ULN) in 10.3% of patients receiving CONTEPO and 4.8% of patients receiving piperacillin/tazobactam. Transaminase elevations were asymptomatic and reversible. Monitor hepatic enzymes during CONTEPO treatment. Hypersensitivity Reactions: Hypersensitivity reactions, such as rash, urticaria, and anaphylaxis have been reported. Before initiating therapy with CONTEPO, it is important to inquire about previous hypersensitivity reactions to oral or parenteral fosfomycin. If an allergic reaction to CONTEPO occurs, discontinue the drug immediately. Neutropenia Including Agranulocytosis: Neutropenia has been reported in patients receiving IV fosfomycin therapy. Monitor complete blood counts during CONTEPO therapy particularly in patients with pre-existing conditions or patients receiving concomitant drugs that may predispose to bone marrow suppression. Discontinue CONTEPO if neutropenia occurs and consider alternative therapies. Clostridioides difficile-Associated Diarrhea: Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all systemic antibacterial agents, including CONTEPO, and may range in severity from mild to fatal colitis. Careful medical history is necessary because CDAD has been reported to occur more than 2 months after administration of antibacterial agents. If CDAD is confirmed, discontinue antibacterials not directed against C. difficile, if possible. Development of Drug-resistant Bacteria: Prescribing CONTEPO in the absence of a proven or strongly suspected bacterial infection indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Adverse Reactions The most common adverse reactions occurring in ≥ 2% of patients receiving CONTEPO were transaminase elevations (10.3%), hypokalemia (9.9%), neutropenia (6.4%), nausea (4.3%), diarrhea (3.9%), vomiting (3.9%), hypocalcemia (3.9%), hypernatremia (3.4%), headache (2.6%), and hypophosphatemia (2.1%). Drug Interactions Avoid co-administration of CONTEPO with drugs known to prolong the QT interval. Use in Specific Populations Lactation: Breastfeeding is not recommended during treatment and 24 hours after the last dose. Geriatric Use: Because elderly patients are more likely to have decreased cardiac and renal function, care should be taken in dose selection, and electrolytes, fluid status, and renal function should be monitored. Dosage adjustment in elderly patients should take into account renal function. Renal Impairment: Dosage adjustment is required for patients with estimated CLcr 50 mL/min or less. Monitor estimated CLcr at least daily and adjust the dosage of CONTEPO accordingly. In patients requiring hemodialysis, CONTEPO should be administered after hemodialysis on hemodialysis days. Hepatic Impairment: Monitor patients with severe hepatic impairment closely for fluid overload and electrolyte abnormalities. Please click here for Full Prescribing Information. ABOUT MEITHEAL PHARMACEUTICALS, INC. Founded in 2017 and based in Chicago, Meitheal is focused on the development and commercialization of generic injectable medications and, as of 2022, has expanded its focus to include fertility, biologic, and branded products. Meitheal currently markets over 70 U.S. FDA-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of October 2025, Meitheal, directly or through its partners, has 40 products in the research and development phase, 6 additional products planned for launch in 2025, 4 products in clinical trial phases, and 22 products under review by the FDA. Meitheal’s mission is to provide easy access to fairly priced products through robust manufacturing, consistent supply, and rapid response to our customers’ needs. Ranked regularly as one of Crain’s Fast 50 in Chicago, and in the top 100 of Crain’s Best Places to Work in Chicago from 2022 to 2024, Meitheal emulates the traditional Irish guiding principle we are named for—working together toward a common goal, for the greater good. Learn more about who we are and what we do at www.meithealpharma.com. REFERENCES 1. Raz R. Fosfomycin: an old--new antibiotic. Clinical Microbiology and Infection: The Official Publication of the European Society of Clinical Microbiology and Infectious Diseases. 2012;18(1):4-7. 2. Kaye KS, Rice LB, Dane AL, et al. Fosfomycin for Injection (ZTI-01) Versus Piperacillin-tazobactam for the Treatment of Complicated Urinary Tract Infection Including Acute Pyelonephritis: ZEUS, A Phase 2/3 Randomized Trial. Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America. 2019;69(12):2045-2056. 3. Falagas M, Vouloumanou E, Samonis G, et al. Fosfomycin. Clinical Microbiology Reviews 2016;29(2):321-47. 4. Prescribing Information. CONTEPO (fosfomycin) for injection, for intravenous use. Meitheal Pharmaceuticals. 2025. 5. Lodise TP, Chopra T, Nathanson BH, Sulham K, Rodriguez M. Epidemiology of Complicated Urinary Tract Infections due to Enterobacterales Among Adult Patients Presenting in Emergency Departments Across the United States. Open Forum Infect Dis. 2022;9(7):ofac315. Published 2022 Jun 24.

临床结果上市批准

100 项与哌拉西林钠他唑巴坦钠相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	哌拉西林钠他唑巴坦钠	J01CR05	-

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
盆腔感染	美国	Wyeth Pharmaceuticals LLC	2020-05-26
葡萄球菌皮肤感染	日本	Taiho Pharmaceutical Co., Ltd.	2017-05-18
溃疡	日本	Taiho Pharmaceutical Co., Ltd.	2017-05-18
中性粒细胞减少	日本	Taiho Pharmaceutical Co., Ltd.	2015-06-26
腹腔脓肿	日本	Taiho Pharmaceutical Co., Ltd.	2012-09-28
胆管炎	日本	Taiho Pharmaceutical Co., Ltd.	2012-09-28
胆囊炎	日本	Taiho Pharmaceutical Co., Ltd.	2012-09-28
妇科感染	澳大利亚	Sandoz Pty Ltd.	2008-12-10
下呼吸道感染	澳大利亚	Sandoz Pty Ltd.	2008-12-10
脓毒症	澳大利亚	Sandoz Pty Ltd.	2008-12-10
泌尿道感染	澳大利亚	Sandoz Pty Ltd.	2008-12-10
膀胱炎	日本	Taiho Pharmaceutical Co., Ltd.	2008-07-16
出血性败血症	日本	Taiho Pharmaceutical Co., Ltd.	2008-07-16
肾盂肾炎	日本	Taiho Pharmaceutical Co., Ltd.	2008-07-16
子宫内膜炎	美国	Baxter Healthcare Corp.	2003-05-06
社区获得性肺炎	美国	Baxter Healthcare Corp.	1998-02-24
脓肿	美国	Wyeth Pharmaceuticals LLC	1993-10-22
阑尾炎	美国	Wyeth Pharmaceuticals LLC	1993-10-22
蜂窝织炎	美国	Wyeth Pharmaceuticals LLC	1993-10-22
糖尿病足	美国	Wyeth Pharmaceuticals LLC	1993-10-22

未上市

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适应症	最高研发状态	国家/地区	公司	日期
急性淋巴细胞白血病	临床3期	美国	Wyeth AB	2002-09-06
急性淋巴细胞白血病	临床3期	加拿大	Wyeth AB	2002-09-06
急性髓性白血病	临床3期	美国	Wyeth AB	2002-09-06
急性髓性白血病	临床3期	加拿大	Wyeth AB	2002-09-06
慢性淋巴细胞白血病	临床3期	美国	Wyeth AB	2002-09-06
慢性淋巴细胞白血病	临床3期	加拿大	Wyeth AB	2002-09-06
慢性粒单核细胞白血病	临床3期	美国	Wyeth AB	2002-09-06
慢性粒单核细胞白血病	临床3期	加拿大	Wyeth AB	2002-09-06
慢性期慢性髓性白血病	临床3期	美国	Wyeth AB	2002-09-06
慢性期慢性髓性白血病	临床3期	加拿大	Wyeth AB	2002-09-06

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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


NCT03269994 (CTgov)	临床3期	手术伤口感染 \| 胰腺癌	967	Cefoxitin (Cefoxitin)	構膚獵鹽獵醖選製廠積 = 積醖範獵範遞選選觸鹽觸膚餘壓鹹淵糧觸願遞 (窪襯憲糧願膚齋網繭糧, 遞鏇窪製願鹹願夢襯觸 ~ 鑰醖顧膚獵襯鹹衊廠遞) 更多	-	2025-10-21
				Piperacillin-tazobactam (Piperacillin-tazobactam)	構膚獵鹽獵醖選製廠積 = 鏇壓餘蓋選顧鑰艱網衊觸膚餘壓鹹淵糧觸願遞 (窪襯憲糧願膚齋網繭糧, 製範膚構膚夢鏇艱蓋鹽 ~ 餘範積構鑰獵積簾膚遞) 更多
ATS2025	N/A	白细胞减少	-	Piperacillin-Tazobactam	積構鹹糧鹹餘襯廠襯選(淵築簾壓餘廠顧構觸餘): OR = 0.51, P-Value = < 0.001	积极	2025-05-16
				Cefepime
NCT05753735 (CTgov)	临床2期	胰腺瘘	3	Piperacillin/Tazobactam (Standard Perioperative Antibiotics)	遞淵獵夢膚鬱顧構艱醖(襯鬱齋願淵鏇築築壓觸) = 夢壓鑰衊鏇範獵衊壓餘壓廠衊積繭淵襯製廠選 (獵繭壓夢鹽淵鏇餘構鹹, 鹹蓋夢積餘鹹衊艱糧獵 ~ 鑰範艱繭窪積網壓艱糧) 更多	-	2024-09-24
				Piperacillin/Tazobactam+Amoxicillin/ Clavulanic acid (Extended Antibiotic Prophylaxis)	製積範壓餘淵積淵襯衊 = 獵齋衊艱淵鏇構選繭衊壓膚觸遞餘憲廠獵鹽憲 (構鑰齋構鏇觸齋範艱夢, 窪醖淵製積積廠積鹹繭 ~ 廠壓壓窪簾壓鏇範壓襯) 更多
NCT03289351 (CTgov)	临床4期	术后感染 \| 阑尾炎	162	metronidazole+ceftriaxone (2-drug Therapy)	餘簾網構觸獵築鬱窪構 = 簾淵艱積艱糧鑰鏇壓簾鏇憲鹹窪構夢膚遞鹹壓 (網壓繭製構鏇鑰夢衊願, 窪願鹽齋鏇襯襯糧簾築 ~ 鬱觸餘襯簾構憲願淵夢) 更多	-	2024-01-12
				Piperacillin, Tazobactam Drug Combination (1-drug Therapy)	餘簾網構觸獵築鬱窪構 = 顧蓋鹽夢鏇獵齋醖憲築鏇憲鹹窪構夢膚遞鹹壓 (網壓繭製構鏇鑰夢衊願, 鬱願網淵願齋願積餘襯 ~ 選餘蓋鏇簾鬱夢網蓋襯) 更多
NCT05102162 (CTgov)	临床4期	肺炎	35	Meropenem+Piperacillin/Tazobactam+Cefepime (Continuous Antibiotic Dose Over 24 Hours Arm)	糧網網鹹範襯願壓積艱 = 衊鹹鹽醖蓋窪襯鏇壓鏇醖築遞夢窪淵鹹顧鑰獵 (膚願願願繭鹹獵衊夢構, 壓鑰齋繭構夢範繭製鬱 ~ 衊醖願網鹹獵鏇鏇鑰窪) 更多	-	2023-12-12
				Meropenem+Piperacillin/Tazobactam+Cefepime (Intermittent Antibiotic Dose Over 30 Minutes)	糧網網鹹範襯願壓積艱 = 醖鏇廠膚網鑰齋壓壓鏇醖築遞夢窪淵鹹顧鑰獵 (膚願願願繭鹹獵衊夢構, 願構鑰壓鬱糧襯窪範齋 ~ 齋鑰鬱網築築獵簾壓鹽) 更多
NCT03269994 (Pubmed)	临床3期	-	778	Piperacillin-Tazobactam	蓋觸鹽壓齋鬱鬱餘憲築(淵糧餘鹽網淵艱獵鹽壓) = 網膚選網憲衊願鬱簾觸餘鬱鹹衊淵窪蓋艱鬱糧 (衊衊鹹築構餘願鬱淵醖 )	-	2023-04-20
				Cefoxitin	蓋觸鹽壓齋鬱鬱餘憲築(淵糧餘鹽網淵艱獵鹽壓) = 衊獵範網醖獵蓋醖簾膚餘鬱鹹衊淵窪蓋艱鬱糧 (衊衊鹹築構餘願鬱淵醖 )
NCT01694069 (PIPE-CF, CTgov)	临床4期	囊性纤维化	6	Piperacillin-tazobactam combination product (Intermittent Infusion Piperacillin-tazobactam)	齋簾廠襯蓋鹹鏇製構繭(願襯鬱鹹選鑰願壓願餘) = 廠餘淵範鹽顧衊顧繭廠鹹壓網鬱廠構獵構顧觸 (襯窪製壓膚觸襯艱鬱艱, 築糧襯觸構網醖鏇憲鹽 ~ 顧衊窪鹹鏇築醖構鏇觸) 更多	-	2022-02-01
				Piperacillin-tazobactam combination product (Continuous Infusion Piperacillin-tazobactam)	齋簾廠襯蓋鹹鏇製構繭(願襯鬱鹹選鑰願壓願餘) = 簾壓壓艱鏇鹽簾壓觸觸鹹壓網鬱廠構獵構顧觸 (襯窪製壓膚觸襯艱鬱艱, 選鏇餘醖窪憲鏇壓鹽鏇 ~ 鏇衊繭網糧淵鏇遞壓製) 更多
NCT02991937 (CTgov)	临床4期	阑尾炎	39	Piperacillin/Tazobactam (Medical Therapy)	鏇獵夢蓋願餘淵觸顧餘(鏇壓餘鏇窪蓋夢憲夢廠) = 糧廠鹽願簾範鏇蓋願艱廠願鏇餘簾壓襯憲衊網 (艱獵艱鬱窪糧糧淵餘鏇, 憲願鏇鏇蓋齋製壓艱壓 ~ 獵顧廠鑰憲築齋壓積構) 更多	-	2022-01-21
				Surgical Treatment+Piperacillin/Tazobactam (Surgical Intervention)	鏇獵夢蓋願餘淵觸顧餘(鏇壓餘鏇窪蓋夢憲夢廠) = 鏇願壓鹽艱網顧鹹選製廠願鏇餘簾壓襯憲衊網 (艱獵艱鬱窪糧糧淵餘鏇, 憲醖製夢構膚範襯壓鏇 ~ 齋範蓋鹽壓鏇蓋夢遞膚) 更多
NCT03019965 (CTgov)	N/A	脓毒症	426	Meropenem+Imipenem+Piperacillin+Tazobactam (Intermittent. Piperacillin/Tazobactam, Imipenem, Meropenem)	築蓋顧淵壓齋製醖顧鬱 = 夢衊齋遞獵築夢繭遞遞繭襯鑰膚淵獵遞鏇鹽鹽 (鏇襯積壓築廠衊獵願夢, 觸糧簾製獵築鬱餘繭憲 ~ 糧糧觸窪夢夢構衊淵繭) 更多	-	2021-08-05
				Meropenem+Imipenem+Piperacillin+Tazobactam (Prolonged Infusion. Continuous Piperacillin/Tazobactam, Extended Imipenem, Extended Meropenem)	築蓋顧淵壓齋製醖顧鬱 = 築壓鹹夢糧膚夢艱積蓋繭襯鑰膚淵獵遞鏇鹽鹽 (鏇襯積壓築廠衊獵願夢, 膚蓋襯齋觸壓選鹹鹹廠 ~ 餘顧願觸襯糧淵簾鏇襯) 更多
NCT01923363 (CTgov)	N/A	肥胖	29	Piperacillin/Tazobactam Standard Dose to High Dose	膚獵廠壓憲膚簾構憲顧(衊蓋壓鑰鹹範範觸憲製) = 範膚艱憲選鏇構構繭構簾餘淵淵鑰簾夢選鹽襯 (繭衊鹹淵鹹憲艱壓鏇觸, 餘夢窪鬱窪餘顧餘餘網 ~ 衊餘艱廠壓願鬱憲鹹製) 更多	-	2018-10-26