A Multicenter, Open-label, Single-arm, Multiple-dose Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Ceftobiprole Medocaril in Term and Pre-term Neonates and Infants up to 3 Months of Age With Late-onset Sepsis

This study will evaluate the safety, pharmacokinetics and efficacy of ceftobiprole in term and pre-term newborn babies and infants up to 3 months of age with late-onset sepsis (LOS). Ceftobiprole is an antibiotic which belongs to a group of medicines called 'cephalosporin antibiotics'. It is approved for its use to treat adults and children with pneumonia in many European and non-European countries.

开始日期2023-08-06

申办/合作机构

Basilea Pharmaceutica AG

NCT04171674 / Unknown statusN/AIIT

A Study on Plasma and Pulmonary Pharmacokinetics of High-dose Ceftobiprole Given by Continuous Infusion in Mechanically-ventilated Adult Patients With Severe Community-acquired Pneumonia

The main aim of the study is to describe plasma pharmacokinetics (PK) and pulmonary diffusion of high-dose ceftobiprole (500 mg loading dose followed by 2.5 g under continuous infusion for 24h) for mechanically-ventilated adult patients with severe community-acquired pneumonia, using population PK modelling.
The secondary aims are :
A- To determine whether the pharmacokinetic / pharmacodynamic (PK/PD) targets can be achieved in the plasma and epithelial lining fluid with the recommended doses of ceftobiprole.
B- To define the optimal dose regimen for ceftobiprole in this population.
C- To evaluate clinical recovery (at Day 3 and Day 8) and microbiological recovery (at Day 3).
D- To evaluate the clinical evolution.
E- To evaluate the clinical and biological tolerance.

开始日期2021-09-01

申办/合作机构

Centre Hospitalier Universitaire de Bordeaux

NCT04170309 / CompletedN/A

Retrospective Chart Review to Evaluate the Safety Profile of Ceftobiprole in Patients With Impaired Hepatic or Renal Function or Immunosuppression

In this observational study, data from patients treated with the antibiotic ceftobiprole in the past will be collected. The sponsor of the study is Correvio International Sárl, based in Switzerland. Correvio has committed to the health authorities to obtain further information on possible side effects especially in patients suffering from impaired liver or renal function or immune system deficiency and compare these effects to the ones observed in patients without these health problems. Patient data are collected from historic patient charts, patients will not be treated for the purpose of this data collection. All efforts are being made to capture the data of all patients who meet the inclusion criteria and have received at least one dose of ceftobiprole since this drug was first prescribed at the site.

开始日期2020-03-30

申办/合作机构

Advanz Pharma Corp. Ltd.

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100 项与头孢比罗酯钠相关的临床结果

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100 项与头孢比罗酯钠相关的转化医学

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100 项与头孢比罗酯钠相关的专利（医药）

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项与头孢比罗酯钠相关的文献（医药）

2024-02-13·Journal of chemotherapy (Florence, Italy)

Evaluation of in vitro activity of ceftaroline, ceftobiprole and their combination with trimethoprim/sulfamethoxazole against MRSA isolates: a two center study.

Article

作者: Hasan Cenk Mirza ; Özlem Öğüç Şanlı

There is an increasing need for new synergistic antimicrobial combinations against multidrug-resistant bacteria. Our objective was to evaluate the activity of ceftaroline, ceftobiprole and their combination with trimethoprim/sulfamethoxazole against methicillin-resistant Staphylococcus aureus (MRSA) isolates recovered at two centers in Turkey. Activities of ceftaroline and ceftobiprole were tested against 100 MRSA isolates using gradient diffusion method. Activities of ceftaroline and ceftobiprole in combination with trimethoprim/sulfamethoxazole against 20 selected isolates (including all isolates that were non-susceptible to ceftaroline or ceftobiprole, and randomly selected isolates) were investigated using MIC:MIC ratio method. Antimicrobial interactions were interpreted using the fractional inhibitory concentration (FIC) index. The MIC₅₀/MIC₉₀ values for ceftaroline and ceftobiprole were 0.75/1 and 1/1.5 mg/L, respectively. Ceftaroline and ceftobiprole susceptibility rates among 100 MRSA isolates were 94% and 96%, respectively. Ceftaroline, ceftobiprole and trimethoprim/sulfamethoxazole MICs of isolates were not increased when ceftaroline or ceftobiprole was combined with trimethoprim/sulfamethoxazole. Ceftobiprole- trimethoprim/sulfamethoxazole combination demonstrated additivity against 35%, whereas ceftaroline- trimethoprim/sulfamethoxazole combination demonstrated additivity against 10% of 20 MRSA isolates. The remaining interactions for MRSA isolates were indifference. Three (75%) of four ceftobiprole-resistant isolates became susceptible to ceftobiprole after adding trimethoprim/sulfamethoxazole. None of the ceftaroline non-susceptible isolates became susceptible to ceftaroline after adding trimethoprim/sulfamethoxazole. Ceftobiprole- trimethoprim/sulfamethoxazole combination may be a better treatment option than ceftaroline- trimethoprim/sulfamethoxazole combination for MRSA infections. Clinical studies are needed to confirm the results of our in vitro study.

2024-02-07·Antibiotics (Basel, Switzerland)

In Vitro Antibacterial Activity of Ceftobiprole and Comparator Compounds against Nation-Wide Bloodstream Isolates and Different Sequence Types of MRSA.

Article

作者: Lingqin Li ; Wangxiao Zhou ; Yunbo Chen ; Ping Shen ; Yonghong Xiao

Bloodstream infections by bacteria, especially multidrug-resistant bacteria, remain a worldwide public health concern. We evaluated the antibacterial activity of ceftobiprole and comparable drugs against different bloodstream isolates and different sequence types of methicillin-resistant Staphylococcus aureus (MRSA) in China. We found that MRSA, methicillin-susceptible Staphylococcus aureus (MSSA), and methicillin-susceptible coagulase-negative Staphylococcus (MSCNS) displayed ceftobiprole sensitivity rates of >95%, which are similar to the rates for linezolid, daptomycin, and vancomycin. Of the tested MRCNS strains, 90.4% were sensitive to ceftobiprole. The sensitivities of ST59, ST398, and ST22 MRSA to ceftobiprole were higher than that of ST239. Ceftobiprole's MIC_50/90 value against Enterococcus faecalis was 0.25/2 mg/L, whereas Enterococcus faecium was completely resistant to this drug. Ceftobiprole exhibited no activity against ESBL-positive Enterobacterales, with resistance rates between 78.6% and 100%. For ESBL-negative Enterobacterales, excluding Klebsiella oxytoca, the sensitivity to ceftobiprole was comparable to that of ceftazidime, ceftriaxone, and cefepime. The MIC_50/90 value of ceftobiprole against Pseudomonas aeruginosa was 2/16 mg/L, and for Acinetobacter baumannii, it was 32/>32 mg/L. Thus, ceftobiprole shows excellent antimicrobial activity against ESBL-negative Enterobacterales and Pseudomonas aeruginosa (comparable to that of ceftazidime, ceftriaxone, and cefepime); however, it is not effective against ESBL-positive Enterobacterales and Acinetobacter baumannii. These results provide important information to clinicians.

2024-02-01·Seminars in respiratory and critical care medicine

Antibiotic Strategies for Severe Community-Acquired Pneumonia.

Article

作者: Matteo Bassetti ; Daniele R Giacobbe ; Laura Magnasco ; Alberto Fantin ; Antonio Vena ; Nadia Castaldo

Despite advancements in health systems and intensive care unit (ICU) care, along with the introduction of novel antibiotics and microbiologic techniques, mortality rates in severe community-acquired pneumonia (sCAP) patients have not shown significant improvement. Delayed admission to the ICU is a major risk factor for higher mortality. Apart from choosing the appropriate site of care, prompt and appropriate antibiotic therapy significantly affects the prognosis of sCAP. Treatment regimens involving ceftaroline or ceftobiprole are currently considered the best options for managing patients with sCAP. Additionally, several other molecules, such as delafloxacin, lefamulin, and omadacycline, hold promise as therapeutic strategies for sCAP. This review aims to provide a comprehensive summary of the key challenges in managing adults with severe CAP, focusing on essential aspects related to antibiotic treatment and investigating potential strategies to enhance clinical outcomes in sCAP patients.

项与头孢比罗酯钠相关的新闻（医药）

2024-04-04

·FiercePharma

Basilea completes marathon quest with FDA approval to treat 3 types of infections

Basilea has won FDA approval of Zevtera 15 years after the U.S. regulator originally rejected the antibiotic treatment. Fifteen years after Basilea's antibiotic ceftobiprole sustained a rejection from the FDA, the company has finally won over the U.S. regulator and done so in triplicate. The FDA has approved Basilea’s Zevtera (ceftobiprole) for three different kinds of infections. The nods will help patients who have become resistant to the current stock of available antibiotics in the U.S., most of which have been on the market for decades. Zevtera can be administered to adults with acute bacterial skin and skin structure infections (ABSSSI) and adults with staphylococcus aureus bacteremia (SAB), a bloodstream infection that can be fatal. It also can be used on patients 3 months and older to combat community-acquired bacterial pneumonia (CABP). The SAB approval is particularly important, according to Vance Fowler Jr., M.D., professor in the departments of medicine and molecular genetics and microbiology at the Duke University School of Medicine, because it includes the ability to treat patients with methicillin-resistant staphylococcus aureus (MRSA). “Complicated staphylococcus aureus infections have a high mortality rate and are associated with substantial morbidity,” Fowler said in a release. “We need more options for treating these infections, especially if MRSA is involved.” With the nods, Basilea will gain 10 years of exclusivity in the U.S. for Zevtera as it was designated as a Qualified Infectious Disease Product under the Generate Antibiotics Incentives Now Act. Basilea hopes by the “middle of this year” to sign up a partner to commercialize Zevtera in the U.S., a company spokesperson said, adding that it will be up to the collaborator to establish its price. “We believe the U.S. provides the most important global opportunity for the brand,” Basilea CEO David Veitch said in a release. With the nods, Basilea's share price increased by 11% on the Swiss Exchange. Over the last 15 years, Basilea has gained approvals for Zevtera in more than 80 countries—including China, Canada, Brazil and most of Europe—to treat a variety of infections. But the U.S. has been a stubborn holdout. In 2009, the FDA sent Basilea’s then-worldwide partner Johnson & Johnson a complete response letter (CRL) for its application to treat ABSSSI. The regulator critiqued spotty clinical trial work and requested the companies to conduct two more phase 3 studies. A year later, Basilea regained rights to Zevtera after J&J decided to move on from the drug. In 2014, the FDA sent another CRL, rejecting Zevtera in CABP and requesting a new phase 3 trial. The U.S. has helped Basilea fund additional trials through the Biomedical Advanced Research and Development Authority, which has provided the company $134 million in grants to address the shortfall of antibiotic options. According to the Centers for Disease Control and Prevention, more than 2.8 million people in the U.S. get antimicrobial-resistant infections each year, with 35,000 deaths recorded in 2019. The trio of approvals were backed by separate trials that showed Zevtera provided comparable efficacy against comparator antibiotics. In SAB, Zevtera edged the comparator 70% to 69% in an overall measure of success. In ABSSSI, Zevtera outperformed the comparator 91% to 88%. In CABP, the comparator edged Zevtera 79% to 76%. Zevtera is one of two products marketed by Basilea, with both on sales upswings. Cresemba, which was endorsed by the FDA in 2015, is for invasive fungal infections. Basilea recorded 150 million Swiss francs ($167 million) in revenue last year, which was up 23% from 2022. The company expects another major boost in growth this year, guiding to revenue of 180 million Swiss francs ($200 million).

临床3期上市批准合格传染病产品

2024-04-04

·药明康德

速递 | 一药治三病！FDA批准新一代小分子疗法

▎药明康德内容团队编辑今日，美国FDA宣布批准由Basilea Pharmaceutica所开发的Zevtera（ceftobiprole medocaril sodium，注射用）用于治疗金黄色葡萄球菌菌血症（SAB）的成人患者，包括右侧感染性心内膜炎患者；急性细菌性皮肤和皮肤结构感染（ABSSSI）成人患者；以及社区获得性细菌性肺炎（CABP）的成人和儿童患者，儿童患者的年龄介于3个月至18岁以下。一项随机、对照、双盲、跨国试验评估了Zevtera治疗SAB的疗效。在试验中，研究人员随机分配390名患者接受Zevtera（n=192）或活性对照药物（n=198）治疗。该试验的主要疗效指标是治疗后评估访视的总体成功率（定义为存活率、症状改善、SAB血流清除、无新的SAB并发症和未使用其他潜在有效抗生素），访视发生在随机分配接受治疗70天后。分析显示，接受Zevtera治疗的受试者中，共有69.8%获得总体成功，此数值在活性对照药物组中为68.7%。另一项随机、对照、双盲、跨国试验评估了Zevtera在治疗ABSSSI方面的疗效。在试验中，研究人员随机分配679名受试者接受Zevtera（n=335）或活性对照药物（n=344）治疗。主要疗效指标是治疗开始后48-72小时内患者的早期临床缓解，即患者的原发性皮肤病变减少至少20%，存活至少72小时，并且没有额外的抗菌治疗或预定外的手术。在接受Zevtera治疗的受试者中，91.3%的患者在时间限制内实现了早期临床缓解，而接受对照药物治疗的受试者中这一比例为88.1%。Zevtera治疗成人CABP患者的疗效在一项随机、对照、双盲、多国试验中进行了评估。在试验中，研究人员随机分配638名因CABP住院且需要静脉注射抗菌治疗至少3天的成人接受Zevtera（n=314）或活性对照药物（n=324）。主要疗效指标是治愈测试访视（test-of-cure visit）时的临床治愈率，该访视发生在治疗结束后7-14天。有76.4%的Zevtera组患者实现了临床治愈，而接受对照药物的受试者中这一比例为79.3%。另一项分析考量了较早的临床成功时间点，在第3天有71%接受Zevtera患者达成临床治愈，对照组患者此一比例为71.1%。Zevtera是一款静脉注射的新一代头孢抗生素，可快速杀死多种革兰氏阳性细菌（如金黄色葡萄球菌，包括耐甲氧西林菌株）和革兰氏阴性菌。它已经在欧洲和中国获批上市。美国FDA曾授予其快速通道资格、优先审评与合格传染病产品（QIDP）资格。了解更多FDA获批新药请点击下图访问我们的小程序大家都在看药明康德为全球生物医药行业提供一体化、端到端的新药研发和生产服务，服务范围涵盖化学药研发和生产、生物学研究、临床前测试和临床试验研发、细胞及基因疗法研发、测试和生产等领域。如您有相关业务需求，欢迎点击下方图片填写具体信息。▲如您有任何业务需求，请长按扫描上方二维码，或点击文末“阅读原文/Read more”，即可访问业务对接平台，填写业务需求信息▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料：[1] FDA Approves New Antibiotic for Three Different Uses. Retrieved April 3, 2024 from https://www.fda.gov/news-events/press-announcements/fda-approves-new-antibiotic-three-different-uses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。版权说明：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。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

快速通道优先审批合格传染病产品临床结果

2024-04-04

·BioSpace

Basilea announces US FDA approval of antibiotic ZEVTERA® (ceftobiprole medocaril) for three indications

Ad hoc announcement pursuant to Art. 53 LR Allschwil, Switzerland, April 04, 2024 Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today that the US Food and Drug Administration (FDA) approved ZEVTERA® (ceftobiprole medocaril sodium for injection), for the treatment of adult patients with Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including those with right-sided infective endocarditis, and adult patients with acute bacterial skin and skin structure infections (ABSSSI) and for adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP). David Veitch, Chief Executive Officer of Basilea, said: “We are excited with the US approval of ZEVTERA. The positive decision by the FDA is a key milestone towards bringing ZEVTERA to patients in the US. ZEVTERA has 10 years of market exclusivity from the date of approval and we believe the US provides the most important global commercial opportunity for the brand.” Dr. Marc Engelhardt, Chief Medical Officer of Basilea, stated: “We are very pleased that the FDA approved ZEVTERA for all three indications that were submitted with the NDA, including a pediatric labelling. This approval is a landmark for ceftobiprole and reflects its broad clinical utility. The indication in adult patients with Staphylococcus aureus bacteremia, including those with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates, MSSA and MRSA, addresses a real medical need, as current treatment options are limited.” The New Drug Application (NDA) was supported by clinical efficacy and safety data from the phase 3 studies ERADICATE (SAB)1 and TARGET (ABSSSI),2 and a phase 3 study in CABP.3 The ERADICATE study was the largest double-blind randomized registrational study conducted for a new antibiotic treatment in SAB. Vance G. Fowler, Jr., M.D., Professor in the Departments of Medicine and Molecular Genetics & Microbiology at the Duke University School of Medicine and academic lead investigator of the ERADICATE study, commented: “Complicated Staphylococcus aureus infections have a high mortality rate and are associated with substantial morbidity. We need more options for treating these infections, especially if MRSA is involved.” Thomas Holland, M.D., Associate Professor in the Department of Medicine at the Duke University School of Medicine and chair of the data review committee of the ERADICATE study, added: “There is a high medical need in Staphylococcus aureus bacteremia, therefore, the first approval of a therapy for this indication in over 15 years is highly welcome.” Adesh Kaul, Chief Financial Officer of Basilea, added: “As we were moving towards completion of the regulatory review, especially with increasing visibility on the expected label, the external interest for commercial partnering increased. Whilst our initial goal was to have announced a commercial partnership by the time of approval of ZEVTERA in the US, in order to explore fully all potential partnering opportunities, we now expect to complete the process around mid-year. In parallel, we are also taking preparatory steps to shorten the launch timelines, once we have entered into a commercialization partnership.” Basilea’s phase 3 program for ceftobiprole is funded in part with federal funds from the US Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under contract number HHSO100201600002C. Through this partnership, Basilea has been awarded approximately USD 112 million, or approximately 75 percent of the costs related to the SAB and ABSSSI phase 3 studies, regulatory activities and non-clinical work. About ZEVTERA® (ceftobiprole medocaril sodium for injection) Ceftobiprole, the active moiety of the prodrug ceftobiprole medocaril, is an advanced generation cephalosporin antibiotic for intravenous administration, with rapid bactericidal activity against a wide range of Gram-positive bacteria, such as Staphylococcus aureus, including methicillin-resistant strains (MRSA), and Gram-negative bacteria.4 In several countries in Europe and beyond, the brand is currently approved and marketed as Zevtera® and Mabelio® for the treatment of adult patients with hospital-acquired bacterial pneumonia (HABP), excluding ventilator-associated bacterial pneumonia (VABP), and for the treatment of community-acquired bacterial pneumonia (CABP). Basilea has entered into license and distribution agreements covering more than 80 countries. In the United States, ZEVTERA is indicated for the treatment of adult patients with Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including right-sided infective endocarditis, and adult patients with acute bacterial skin and skin structure infections (ABSSSI) and for adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP). Important US safety information for ZEVTERA (ceftobiprole medocaril sodium for injection) Contraindications ZEVTERA is contraindicated in patients with a known history of severe hypersensitivity to ZEVTERA, or to other members of the cephalosporin class. Warnings and precautions Increased Mortality with Unapproved use in Ventilator-Associated Bacterial Pneumonia (VABP) Patients: The safety and effectiveness of ZEVTERA for the treatment of VABP has not been established and the use of ZEVTERA for VABP is not approved. Hypersensitivity Reactions: Discontinue ZEVTERA if a hypersensitivity reaction occurs, and institute appropriate treatment. Seizures and other adverse central nervous system (CNS) reactions have been associated with the use of ZEVTERA. If seizures or other CNS adverse reactions occur, evaluate patients to determine whether ZEVTERA should be discontinued. Clostridioides difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including ZEVTERA. Evaluate if diarrhea occurs. Adverse reactions SAB (adult patients): The most common adverse reactions occurring in ≥ 4% of adult patients were anemia, nausea, hypokalemia, vomiting, hepatic enzyme and bilirubin increased, diarrhea, blood creatinine increased, hypertension, leukopenia and pyrexia. ABSSSI (adult patients): The most common adverse reactions occurring in ≥ 2% of adult patients were nausea, diarrhea, headache, injection site reaction, hepatic enzyme increased, rash, vomiting, and dysgeusia. CABP (adult and pediatric patients 3 months to less than 18 years of age): Adult Patients: The most common adverse reactions occurring in ≥ 2% of adult patients were nausea, hepatic enzyme increased, vomiting, diarrhea, headache, rash, insomnia, abdominal pain, phlebitis, hypertension and dizziness. Pediatric Patients: The most common adverse reactions occurring in ≥ 2% of pediatric patients were vomiting, headache, hepatic enzyme increased, diarrhea, infusion site reaction, phlebitis and pyrexia. For full US prescribing information, please visit here: About Staphylococcus aureus bacteremia (SAB) Staphylococcus aureus bacteremia (SAB) is a serious bloodstream infection associated with significant morbidity and mortality.5 Complications include concomitant infections such as bone, joint or heart valve infections, persistent bacteremia or bacteremia in patients on dialysis. With a 30-day all-cause mortality of around 20% there is a high medical need for improved therapies for SAB.6 About acute bacterial skin and skin structure infections (ABSSSI) Acute bacterial skin and skin structure infections (ABSSSI) are common infections in the healthcare setting. Staphylococcus aureus is the most common pathogen associated with these infections, which can be difficult to treat if methicillin-resistant Staphylococcus aureus (MRSA) is involved.7 About community-acquired bacterial pneumonia (CABP) Community-acquired bacterial pneumonia (CABP) is a leading cause of morbidity and mortality worldwide. It is the leading cause of infectious disease-related death in the US.8 About Basilea Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit basilea.com. Disclaimer This communication expressly or implicitly contains certain forward-looking statements, such as "believe", "assume", "expect", "forecast", "project", "may", "could", "might", "will" or similar expressions concerning Basilea Pharmaceutica Ltd, Allschwil and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd, Allschwil to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd, Allschwil is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. For further information, please contact: Peer Nils Schröder, PhD Head of Corporate Communications & Investor Relations Basilea Pharmaceutica International Ltd, Allschwil Hegenheimermattweg 167b 4123 Allschwil Switzerland Phone +41 61 606 1102 E-mail media_relations@basilea.com investor_relations@basilea.com This ad hoc announcement can be downloaded from . References ERADICATE study (SAB): ClinicalTrials.gov identifier NCT03138733 T. L. Holland, S. E. Cosgrove, S. B. Doernberg et al. Ceftobiprole for treatment of complicated Staphylococcus aureus bacteremia. New England Journal of Medicine 2023 (389), 1390-1401; DOI: 10.1056/NEJMoa2300220 TARGET study (ABSSSI): ClinicalTrials.gov identifier NCT03137173 J. S. Overcash, C. Kim, R. Keech et al. Ceftobiprole compared with vancomycin plus aztreonam in the treatment of acute bacterial skin and skin structure infections: Results of a phase 3, randomized, double-blind trial (TARGET). Clinical Infectious Diseases 2021 (73), e1507-e1517 CABP study: ClinicalTrials.gov identifier NCT00326287 S. C. Nicholson, T. Welte, T. M. File Jr. et al. A randomised, double-blind trial comparing ceftobiprole medocaril with ceftriaxone with or without linezolid for the treatment of patients with community-acquired pneumonia requiring hospitalization. International Journal of Antimicrobial Agents 2012 (39), 240-246 Summary of Product Characteristics (SmPC) Zevtera: [Accessed: April 03, 2024] A. P. Kourtis, K. Hatfield, J. Baggs et al. Vital signs: Epidemiology and recent trends in methicillin-resistant and in methicillin-susceptible Staphylococcus aureus bloodstream infections – United States. Morbidity and Mortality Weekly Report 2019 (68), 214-219 K. Hamed, M. Engelhardt, M. E. Jones et al. Ceftobiprole versus daptomycin in Staphylococcus aureus bacteremia: a novel protocol for a double-blind, Phase III trial. Future Microbiology 2020 (1), 35-48 J. Edelsberg, C. Taneja, M. Zervos et al. Trends in US hospital admissions for skin and soft tissue infections. Emerging Infectious Diseases 2009 (15), 1516-1518 J. A. Ramirez, T. L. Wiemken, P. Peyrani et al. Adults hospitalized with pneumonia in the United States: Incidence, epidemiology, and mortality. Clinical Infectious Diseases 2017 (65), 1807-1812 Attachment Press release (PDF)

临床3期上市批准引进/卖出临床结果

100 项与头孢比罗酯钠相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	头孢比罗酯钠	J01DI01	DB14733

研发状态

适应症	最高研发状态	国家/地区	公司
社区获得性肺炎	批准上市	巴西更多	Basilea Pharmaceutica AG 更多
医院获得性肺炎	批准上市	巴西更多	Basilea Pharmaceutica AG 更多
社区获得性细菌性肺炎	申请上市	美国更多	Basilea Pharmaceutica AG 更多
右侧感染性心内膜炎	申请上市	美国更多	Basilea Pharmaceutica AG 更多
皮肤和皮肤结构感染	申请上市	美国更多	Basilea Pharmaceutica AG 更多

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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


NCT00210899 (Pubmed \| Clin Infect Dis)	临床3期	复杂皮肤和皮肤结构感染	828	Ceftobiprole medocaril	(繭窪鹹繭夢鬱憲齋構壓) = 簾鹹築繭艱憲鏇觸窪顧蓋範醖網衊衊選構範糧 (蓋顧範顧鏇觸膚衊鏇範 )	-	2008-03-01
				Vancomycin plus ceftazidimeVancomycin plus ceftazidime	(繭窪鹹繭夢鬱憲齋構壓) = 衊構襯獵鬱鏇鏇餘壓艱蓋範醖網衊衊選構範糧 (蓋顧範顧鏇觸膚衊鏇範 )
NCT02527681 (CTgov)	临床1期	细菌感染	15	Ceftobiprole (Ceftobiprole PK Population)	(廠簾壓願醖獵壓網襯範) = 醖膚鬱顧顧選鹽顧夢顧膚範觸窪衊夢鹽積鹽膚 (憲範壓蓋觸觸製網艱鑰, 鬱構範願築憲觸範鏇艱 ~ 鑰齋築廠觸蓋糧網鹹艱) 更多	-	2021-01-06
				Ceftobiprole (Ceftobiprole ITT/Safety Population)	襯構遞窪鹽鏇憲積積觸(觸壓積窪壓製憲蓋範積) = 餘鏇積選糧築齋淵夢獵齋餘築齋範願鑰艱衊選 (繭齋鬱衊鏇鑰夢獵製廠, 膚壓範鹹艱餘範鹹鹹範 ~ 範網齋積獵廠範膚鏇築) 更多
NCT03137173 (FDA_CDER) 人工标引	临床3期	皮肤和皮肤结构感染	679	ZEVTERA 667 mg	(網觸壓顧廠鏇繭築網糧) = 襯糧觸襯襯獵觸網壓夢鬱網選繭築艱鑰範鹹膚 (積窪積襯遞廠糧廠選壓 ) 更多	积极	2024-04-03
				Vancomycin plus aztreonam	(網觸壓顧廠鏇繭築網糧) = 襯願齋鑰鏇鑰顧簾醖願鬱網選繭築艱鑰範鹹膚 (積窪積襯遞廠糧廠選壓 ) 更多
NCT02527681 \| NCT03439124 (Pubmed \| Pediatr Infect Dis J)	N/A	-	-	Ceftobiprole (Neonates and infants up to 3 months of age)	(窪製夢窪齋鬱廠窪鏇膚) = 鹽齋鹽艱衊餘蓋鹹醖觸鹹觸顧鹹鬱餘餘醖鑰艱 (願遞蓋鬱糧壓糧範襯蓋 ) 更多	-	2021-11-01
				Ceftobiprole (Patients 3 months to 17 years of age)	(窪製夢窪齋鬱廠窪鏇膚) = 齋艱獵鹽蓋鹽構蓋獵糧鹹觸顧鹹鬱餘餘醖鑰艱 (願遞蓋鬱糧壓糧範襯蓋 ) 更多
NCT03137173 (TARGET, Pubmed \| Clin Infect Dis) 人工标引	临床3期	皮肤和皮肤结构感染	679	Ceftobiprole Medocaril Sodium	(鏇鏇簾範膚膚獵夢艱獵) = 願廠簾餘衊鏇壓積鹽膚襯蓋廠齋簾願膚簾積構 (夢鬱製餘壓範簾憲繭憲 ) 更多	非劣	2021-10-05
				Vancomycin Hydrochloride+Aztreonam	(鏇鏇簾範膚膚獵夢艱獵) = 壓糧範餘膚鬱襯襯鹹網襯蓋廠齋簾願膚簾積構 (夢鬱製餘壓範簾憲繭憲 ) 更多
NCT00326287 \| NCT03439124 (FDA_CDER) 人工标引	临床3期	社区获得性细菌性肺炎	-	Ceftobiprole medocaril (Adult Patients)	(選製積鹽選齋餘窪艱繭) = 衊積鏇網窪遞衊構願鏇構構繭淵築襯壓鬱鹹鹽 (鏇網衊獵築製餘膚範齋 ) 更多	积极	2024-04-03
				Ceftriaxone with or without Linezolid (Adult Patients)	(選製積鹽選齋餘窪艱繭) = 淵鏇製齋積範憲鹽膚鬱構構繭淵築襯壓鬱鹹鹽 (鏇網衊獵築製餘膚範齋 ) 更多
NCT00229008 \| NCT00210964 (Pubmed \| Clin Infect Dis)	临床3期	医院获得性肺炎	781	Ceftobiprole	製選顧衊鬱網醖襯艱艱(餘網網簾鑰憲選醖築觸) = 鹹築衊構艱蓋餘築網製醖襯顧蓋選餘獵築鹽鑰 (鬱顧鏇網鏇齋願膚壓鬱 ) 更多	-	2014-07-01
				Ceftazidime plus LinezolidCeftazidime plus Linezolid	製選顧衊鬱網醖襯艱艱(餘網網簾鑰憲選醖築觸) = 網網醖鑰鏇顧膚遞糧夢醖襯顧蓋選餘獵築鹽鑰 (鬱顧鏇網鏇齋願膚壓鬱 ) 更多
NCT00326287 (Pubmed \| J Microbiol Immunol Infect)	临床3期	社区获得性肺炎	706	Ceftobiprole medocaril	(鏇繭糧糧糧鏇夢繭繭鬱) = The overall incidence of treatment-related adverse events was higher in the ceftobiprole group, primarily owing to differences in rates of self-limited nausea (7% vs. 2%) and vomiting (5% vs. 2%) 醖鹹廠範襯鏇淵蓋獵餘 (蓋繭觸鏇顧願艱獵鑰鹽 )	积极	2012-03-01
				Ceftriaxone ± linezolid
NCT03138733 (FDA_CDER) 人工标引	临床3期	金黄色葡萄球菌菌血症	387	ZEVTERA	(選壓餘獵齋範製襯製艱) = 廠範選築窪鏇憲蓋簾餘鏇築選齋艱鹹廠顧窪蓋 (範顧選鹹艱廠願構糧淵 ) 更多	积极	2024-04-03
				Daptomycin	(選壓餘獵齋範製襯製艱) = 襯壓繭遞夢鑰製艱餘淵鏇築選齋艱鹹廠顧窪蓋 (範顧選鹹艱廠願構糧淵 ) 更多
NCT03138733 (ERADICATE, Corporate Publications) 人工标引	临床3期	金黄色葡萄球菌菌血症	390	Ceftobiprole Medocaril Sodium	製夢衊築糧艱範襯鹽齋(繭遞齋選壓鹹遞憲淵網) = 蓋襯簾鏇醖齋鹽選構獵蓋憲觸網夢餘鹽鑰鏇選 (廠範齋壓壓餘築鹽壓夢 ) 更多	非劣	2022-10-24
				Aztreonam+Daptomycin	製夢衊築糧艱範襯鹽齋(繭遞齋選壓鹹遞憲淵網) = 顧壓鹽衊夢廠遞襯積蓋蓋憲觸網夢餘鹽鑰鏇選 (廠範齋壓壓餘築鹽壓夢 ) 更多