Ceftazidime Plus Fosfomycin Versus Ceftazidime Alone for Severe Gram-negative Infections: a Triple-blind, Placebo-controlled Point-of-care Randomized Clinical Trial

The goal of this clinical trial is to :
1. Test whether the combination of CAZ±AVI and FOS leads to superior clinical outcomes in patients with severe suspected Gram-negative bacterial infection, as demonstrated by a shorter time to normalization of quick Sequential Organ Failure Assessment (qSOFA) parameters and reduction in C-reactive protein (CRP) compared to standard of care (CAZ±AVI alone)
2. to further characterize the safety profile of this combination therapy
In the presence of such an infection, standard treatment is to start intravenous antibiotic therapy. Ceftazidime (Fortam®), or ceftazidime-avibactam (Zavicefta®), is a standard antibiotic commonly used for this purpose (for very resistant bacteria, the compound avibactam is included to protect ceftazidime from being broken down by bacteria).
Researchers will compare ceftazidime (or ceftazdime-avibactam) plus fosfomycin versus ceftazidime alone with placebo (i.e. a look-alike substance given with no drug) to examine whether the addition of another intravenous antibiotic, fosfomycin, would lead to faster recovery from severe infection and evaluate the tolerability of this combination.
Participants will:
* Be randomly assigned to either the intervention group or the control group.
* The intervention group will receive ceftazidime (with avibactam if multidrug resistant bacteria are suspected, per routine practice) and intravenous fosfomycin, and the control group will receive ceftazidime (with avibactam if multidrug resistant bacteria are suspected) and placebo.
* Either treatment will be given for 3 days, three times daily (or less frequently, depending on renal function).
* Provide a few extra blood samples (for CRP measurement, a protein marker of inflammation) during the first few days of the study.
* Be contacted in the hospital or by phone if discharged on day 28 to be asked a few questions.

开始日期2025-08-25

申办/合作机构

University of Geneva

[+1]

CTRI/2024/11/077239

/ Not yet recruiting临床2期

A phase 2a, 2-part, open-label, non-randomized, multicenter, single and multiple dose trial to evaluate Pharmacokinetics, Safety and Tolerability of Aztreonam and Avibactam plus or minus Metronidazole in neonates and infants from birth to less than 9 months of age with suspected or confirmed infections due to Gram-Negative pathogens requiring intravenous antibiotic treatment. - NIL

开始日期2024-12-09

申办/合作机构

Pfizer Ltd. (India)

NCT06419296

/ CompletedN/AIIT

Mortality of MBL-producing Enterobacteriaceae Bacteremias with the Combined Use of Ceftazidime-avibactam and Aztreonam Vs. Other Active Antibiotics. a Multicenter Target Trial Emulation.

Ceftazidime-avibactam and aztreonam combination (CAZAVI + ATM) presents a potential alternative for the treatment of metallo-beta-lactamase (MBL)-type carbapenemase-producing Enterobacteriaceae (CPE) bacteremia, particularly where Cefiderocol is not readily available.
This study proposes a Target Trial Emulation (TTE) to assess the efficacy and safety of CAZAVI + ATM compared to other active antibiotics (OAAs) in patients with MBL-type CPE bacteremia, and also to evaluate all-cause 30-day mortality, resistance profiles of isolated microorganisms, clinical failure rates, leukocyte count normalization, adverse events, occurrence of Clostridium difficile infection, and emergence of new multidrug-resistant microorganisms.
Data will be collected through the REDCap database, with rigorous verification for completeness and accuracy.
The outcomes of this project will contribute vital insights into the efficacy and safety of CAZAVI + ATM, informing clinical practice guidelines for the management of MBL-type bacteremia across diverse settings.

开始日期2024-06-01

申办/合作机构

Hospital Italiano de Buenos Aires

100 项与阿维巴坦钠相关的临床结果

登录后查看更多信息

100 项与阿维巴坦钠相关的转化医学

登录后查看更多信息

100 项与阿维巴坦钠相关的专利（医药）

登录后查看更多信息

2,537

项与阿维巴坦钠相关的文献（医药）

2025-12-31·Gut Microbes

A modelling framework to characterize the impact of antibiotics on the gut microbiota diversity

Article

作者: de Gunzburg, Jean ; Burdet, Charles ; Corbel, Tanguy ; Ferreira, Stéphanie ; Olivares, Carlos ; Guedj, Jeremie ; Ruppé, Etienne ; Andremont, Antoine

Metagenomic sequencing deepened our knowledge about the role of the intestinal microbiota in human health, and several studies with various methodologies explored its dynamics during antibiotic treatments. We compared the impact of four widely used antibiotics on the gut bacterial diversity. We used plasma and fecal samples collected during and after treatment from healthy volunteers assigned to a 5-day treatment either by ceftriaxone (1 g every 24 h through IV route), ceftazidime/avibactam (2 g/500 mg every 8 h through IV route), piperacillin/tazobactam (1 g/500 mg every 8 h through IV route) or moxifloxacin (400 mg every 24 h through oral route). Antibiotic concentrations were measured in plasma and feces, and bacterial diversity was assessed by the Shannon index from 16S rRNA gene profiling. The relationship between the evolutions of antibiotic fecal exposure and bacterial diversity was modeled using non-linear mixed effects models. We compared the impact of antibiotics on gut microbiota diversity by simulation, using various reconstructed pharmacodynamic indices. Piperacillin/tazobactam was characterized by the highest impact in terms of intensity of perturbation (maximal [IQR] loss of diversity of 27.3% [1.9; 40.0]), while moxifloxacin had the longest duration of perturbation, with a time to return to 95% of baseline value after the last administration of 13.2 d [8.3; 19.1]. Overall, moxifloxacin exhibited the highest global impact, followed by piperacillin/tazobactam, ceftazidime/avibactam and ceftriaxone. Their AUC between day 0 and day 42 of the change of diversity indices from day 0 were, respectively, -13.2 Shannon unit.day [-20.4; -7.9], -10.9 Shannon unit.day [-20.4; -0.6] and -10.1 Shannon unit.day [-18.3; -4.6]. We conclude that antibiotics alter the intestinal diversity to varying degrees, both within and between antibiotics families. Such studies are needed to help antibiotic stewardship in using the antibiotics with the lowest impact on the intestinal microbiota.

2025-12-31·Emerging Microbes & Infections

Whole-genome analysis of NDM-producing Providencia hangzhouensis associated with recurrent bacteraemia with rapid development of aztreonam-avibactam resistance

Article

作者: Chew, Ka Lip ; Lye, Priscillia ; Bakar, Nur Aisyah Binte Abu ; Cruz Cabang, Joey ; Tan, Ker Xin ; Qiao, Yuan ; Teo, Jeanette

A 60-year-old male with recurrent bacteremia associated with necrotizing pancreatitis was followed over 17 months, during which six clinical isolates of Providencia were obtained. The index isolate (R1) was susceptible to aztreonam-avibactam (MIC 4 mg/L), but resistance (MIC >64 mg/L) emerged with isolate B1, collected one month later, and persisted in subsequent isolates. To investigate the genomic and phenotypic evolution of six Providencia clinical isolates, focusing on mechanisms underlying the emergence of aztreonam-avibactam resistance. Whole-genome sequencing was performed to determine species identity, phylogenetic relationships, and resistance determinants. Average nucleotide identity (ANI) and in silico DNA-DNA hybridization (DDH) were used to confirm species classification. Comparative genomic analysis with R1 as a reference identified mutations associated with resistance. Structural modelling assessed the functional impact of key mutations. All isolates were sequence type ST44. Phylogenomic analysis revealed the isolates were more closely related to Providencia hangzhouensis than P. rettgeri, supported by ANI (97%) and DDH (76%). All isolates harboured bla_NDM-1, correlating with carbapenem resistance. Resistant isolates displayed a glycine insertion at position 420 in PBP3 (p.Gly420dup), which structural modelling indicated disrupted aztreonam-avibactam binding. A Gly151Asp substitution in OmpC was also identified, potentially affecting drug permeability. No mutations were observed in other porins (OmpA, OmpD, or OmpW). This study identifies a glycine insertion in PBP3 as a novel mechanism driving aztreonam-avibactam resistance in Providencia, supported by structural modelling and additional mutations in OmpC. This study provides evidence of a novel resistance mechanism to aztreonam-avibactam in Providencia, driven by a glycine insertion in PBP3 and supported by alterations in OmpC.

2025-12-01·DIAGNOSTIC MICROBIOLOGY AND INFECTIOUS DISEASE

Carriage and infections by multi-carbapenemases producing Enterobacterales

Article

作者: Costa, Cristina ; Bastos, Paulo ; Boattini, Matteo ; Bianco, Gabriele

INTRODUCTION:

Multi-carbapenemases producing Enterobacterales (MCP-EB) represents a new public health challenge due to their ability to display complex resistance phenotypes.

METHODS:

MCP-EB isolates identified from patients admitted to an Italian Center in the period 2020-2024 were included. Clinical features were collected.

RESULTS:

Among 3,117 carbapenemase-producing Enterobacterales clinical strains, 31 (1 %) were MCP-EB and were detected from 28 patients. The most common MCP-EB species was Klebsiella pneumoniae (78.6 %; n = 22). Six combinations of two different carbapenemases were observed: KPC+VIM (75 %; n = 21), KPC+NDM (10.7 %; n=3), VIM+NDM (10.7 %; n = 3), KPC+OXA-48-like (3.6 %; n = 1), VIM+OXA-48-like (7.1 %; n = 2), and NDM+OXA-48-like (3.6 %; n = 1). Patients with MCP-EB had a median age of 67 years [IQR 59-73], were predominantly men (57.1 %; n = 16), and a median Charlson Comorbidity Index of 5 [IQR 4-6]. The comorbidities mainly observed were cardiovascular disease (53.6 %; n = 15), chronic respiratory disease (39.3 %; n = 11), and chronic kidney disease (32.1 %; n = 9). Fifty per cent (n = 14) of patients had been hospitalized in the previous 180 days and 75 % (n = 21) had been exposed to antibiotics in the previous 30 days. Median time from admission to MCP-EB specimen collection was 16 days [IQR 10-24] and 28.6 % (n = 8) of patients showed to carry MCP-EB in more than two body districts. Fourteen-day, 30-day, and in-hospital mortality were 10.7 %, 25 %, and 32.1 %, respectively. MCP-EB showed high rates of resistance to all antibiotics tested except aztreonam/avibactam. Patients with MCP-EB infection (35.7 %; n = 10) were treated with combination regimens, mainly including aztreonam plus ceftazidime/avibactam or cefiderocol. Two patients (20 %) had a recurrence of MCP-EB infection and four (40 %) patients did not survive hospitalisation.

CONCLUSION:

Clinical features of patients with MCP-EB are common in the hospital population with chronic diseases and showed high mortality rates both in infected and carriers-only patients. Aztreonam/avibactam and cefiderocol could be promising treatment options against MCP-EB infections.

项与阿维巴坦钠相关的新闻（医药）

2025-08-15

·GBIHealth

礼来替尔泊肽在英国涨价170%

药械追踪 No.1 / 礼来减肥疗法Mounjaro在英国涨价170% 2025年8月14日，礼来（NYSE：LLY）宣布，减肥治疗药物Mounjaro（替尔泊肽）在英国的官方价格将上涨高达170%。新的价格将于9月生效，同样适用于其同名的2型糖尿病药物。该公司表示，最高剂量的药物一个月的供应价格将从122英镑提高到330英镑。礼来的一位发言人表示，价格上涨将影响那些私人支付Mounjaro费用的人，但不会影响通过英国公共医疗系统（该系统有单独的协议）获得该药的患者。这一举动反映了制药行业应对美国市场政策变化的行动。美国总统唐纳德·特朗普正在推动国内药品降价，并鼓励海外涨价。上周，礼来公司首席执行官戴维·里克斯在一次投资者电话会议上表示，从长远来看，美国和欧洲的药品定价保持一致是可取的，但他警告称，欧洲各国政府“不会同意为药品支付更多费用”。礼来表示，正在与英国的私人医疗服务提供商（例如在线药店）合作，这些提供商可以设定自己的价格，以确保药品的持续供应。 ->点击文末阅读原文，解锁完整双语新闻 No.2 / 全球首款！Precigen旗下复发性呼吸道乳头状瘤病免疫疗法获美国FDA批准 2025年8月14日，美国食品药品监督管理局（FDA）批准Precigen公司旗下Papzimeos（zopapogene imadenovec-drba）上市，这是首款用于治疗成人复发性呼吸道乳头状瘤病（RRP）的基于非复制型腺病毒载体的免疫疗法。 RRP是一种由持续性人乳头瘤病毒（HPV）6型或11型感染引发的罕见慢性疾病，会导致呼吸道（最常见于喉部）良性肿瘤生长。该病具有显著致残性，可引发声音改变、呼吸困难及气道阻塞等症状。目前尚无获批的药物治疗方案可替代反复手术干预，患者存在重大未满足医疗需求。Papzimeos通过皮下注射给药，旨在激发针对HPV 6型和11型感染细胞的免疫应答。该疗法提供了与传统治疗（主要依赖反复手术）截然不同的作用机制，为患者提供了全新选择，有望彻底改变RRP的治疗格局。 ->点击文末阅读原文，解锁完整双语新闻 No.3 / 辉瑞新型抗菌药思福诺全国首方落地 2025年8月13日，辉瑞旗下新型抗菌药物思福诺（注射用氨曲南阿维巴坦钠，以下简称"氨曲南/阿维巴坦"）在上海多家医院开出全国首日处方。此前，该产品于2025年6月获得国家药品监督管理局正式批准，用于治疗由革兰阴性菌引起的治疗药物选择有限或无替代治疗的成人复杂性腹腔内感染（cIAI），医院获得性肺炎（HAP），包括呼吸机相关性肺炎（VAP）。思福诺是全球首个针对产金属β-内酰胺酶（MBL）细菌、覆盖碳青霉烯耐药肠杆菌目细菌（CRE）全酶型的β-内酰胺类抗生素/β-内酰胺酶抑制剂复方制剂，思福诺的上市标志着我国在应对多重耐药革兰阴性菌感染治疗领域迎来突破性进展，开创抗感染治疗迈向精准治疗新格局。 ->点击文末阅读原文，解锁完整双语新闻行业政策 No.1 / 国家医保局发布医疗保障按病种付费管理暂行办法 2025年8月15日，国家医保局发布《医疗保障按病种付费管理暂行办法》，自下发之日起施行。本办法适用于医保部门以按病种付费方式与医疗机构结算住院医疗费用的管理，按病种付费包括按病组（DRG）付费和按病种分值（DIP）付费两种形式。国家医保局负责制定和调整国家版病种分组方案。DRG分组包括主要诊断大类、核心分组和细分组。主要诊断大类根据解剖部位和疾病性质确定，核心分组主要通过临床论证进行调整，可由相关学（协）会开展行业论证，也可开展多学科联合论证。DIP病种库包括核心病种和综合病种。通过设置病例数临界值区分核心病种与综合病种，病例数达到临界值以上的病种组合归入核心病种，作为DIP结算的主要付费单元。医保部门建立特例单议机制，完善相关制度，规范特例单议标准、申报程序、审核流程、结算办法等，结合国家支持创新药和医疗器械发展有关政策要求，支持医疗机构收治复杂重症患者、合理使用新药耗新技术。申报特例单议的病例包括但不限于因住院时间长、资源消耗多、合理使用新药耗新技术、复杂危重症或多学科联合诊疗等，不适合应用病种支付标准的病例。特例单议病例数量原则上不超过统筹地区DRG出院总病例的5%或DIP出院总病例的5‰。 ->点击阅读原文，解锁完整双语新闻全球医疗情报领导者解锁隐藏在数据中的商业潜力关于 G B I ” 自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。联系我们投稿 | 发稿 | 媒体合作 ▶ olivia.xu@generalbiologic.com 数据库 | 咨询服务 | 资讯追踪 ▶ 点击左下“阅读原文”完成表单填写点击阅读原文，解锁完整双语新闻

免疫疗法上市批准

2025-07-09

·BioBAY

信诺维1类新药注射用亚胺西福申报上市获受理！

2025年7月8日，国家药品监督管理局（NMPA）正式受理BioBAY园内企业信诺维在研β-内酰胺类/β-内酰胺酶抑制剂（BL/BLI）复方制剂1类新药——注射用亚胺培南西司他丁钠福诺巴坦（注射用亚胺西福）的上市申请（NDA），受理号：CXHS2500074。该药物是全球首个针对三大碳青霉烯类耐药革兰阴性杆菌（CRO）具有广谱抗菌活性的BL/BLI复方制剂，拟用于治疗医院获得性细菌性肺炎和呼吸机相关性细菌性肺炎（HABP/VABP）。此次申报基于XNW4107-302国际多中心III期临床研究（Reitab Study）的积极结果。这项随机、双盲、阳性对照研究共纳入450例患者，结果显示：疗效显著：第 14 天全因死亡率达到预设主要终点优势突出：对碳青霉烯类耐药人群的临床治疗成功率和微生物清除率均优于对照组（注射用亚胺西瑞）安全性良好：整体耐受性良好，安全性特征符合预期*其相关研究结果计划在未来的学术会议或学术期刊上发表。注射用亚胺西福对世界卫生组织（WHO）认定的三大 “最严重威胁” 耐药菌同时有效：碳青霉烯类耐药鲍曼不动杆菌（CRAB）碳青霉烯类耐药肠杆菌目细菌（CRE）碳青霉烯类耐药铜绿假单胞菌（CRPA）细菌耐药是当前全球公共卫生领域的重大挑战。根据中国细菌耐药监测网（CHINET）数据显示，CRO检出率持续保持高位，且药物治疗选择少。信诺维自创立之初就专注解决这一未被满足的临床需求，福诺巴坦（XNW4107）较其他新型BLI（如阿维巴坦、瑞莱巴坦等）具有更广、更强的抑酶活性，能全面有效抑制革兰阴性菌常见的A、C、D类酶活性，尤其是CRAB所产的OXA-23酶和CRE所产的KPC酶和OXA-48酶等。乐美杰信诺维首席执行官此次国家药监局受理注射用亚胺西福的上市申请，标志着信诺维在抗感染领域取得重要突破。“以创新科技守护人类健康”是信诺维始终坚守的使命。我们将持续关注抗感染领域的未尽需求，积极配合监管部门的审评工作，推动这一重要创新药物早日获批上市，为临床提供更多优质治疗选择，共同守护国民健康。注射用亚胺西福上市申请获受理是公司发展的重要里程碑，作为自主研发的新型BL/BLI复方制剂，在HABP/VABP治疗领域，其有潜力成为目前市场上唯一广谱、对重大耐药菌具有强大抗菌活性的治疗药物，有望为中国HABP/VABP患者带来全新的治疗选择，或将显著改善临床治疗结局。▌文章来源：信诺维责编：于嘉敏审核：任旭推荐阅读研发动态丨赛纳思医疗：治疗梗阻性肥厚型心肌病的创新疗法获批进入创新器械“绿色通道”研发动态丨圣因生物：靶向CFB用于补体相关疾病的siRNA药物完成首例受试者给药研发动态丨海迈医疗：首个国产生物型人工血管FIM临床研究结果正式公布

临床3期上市批准

2025-07-09

·医药观澜

速递丨信诺维1类抗菌新药「注射用亚胺西福」申报上市

7月8日，信诺维宣布，中国国家药品监督管理局（NMPA）正式受理其在研β-内酰胺类/β-内酰胺酶抑制剂（BL/BLI）复方制剂1类新药——注射用亚胺培南西司他丁钠福诺巴坦（注射用亚胺西福）的上市申请（NDA）。该药物是一款针对三大碳青霉烯类耐药革兰阴性杆菌具有广谱抗菌活性的BL/BLI复方制剂，拟用于治疗医院获得性细菌性肺炎和呼吸机相关性细菌性肺炎（HABP/VABP）。据信诺维新闻稿介绍，注射用亚胺西福对世界卫生组织（WHO）认定的三大 “最严重威胁” 耐药菌同时有效：碳青霉烯类耐药鲍曼不动杆菌（CRAB）、碳青霉烯类耐药肠杆菌目细菌（CRE）、碳青霉烯类耐药铜绿假单胞菌（CRPA）。福诺巴坦（XNW4107）较其他新型BLI（如阿维巴坦、瑞莱巴坦等）具有更广、更强的抑酶活性，能全面有效抑制革兰阴性菌常见的A、C、D类酶活性，尤其是CRAB所产的OXA-23酶和CRE所产的KPC酶和OXA-48酶等。此次申报基于XNW4107-302国际多中心3期临床研究（Reitab Study）的积极结果。这项随机、双盲、阳性对照研究共纳入450例患者，结果显示：疗效显著：第 14 天全因死亡率达到预设主要终点；优势突出：对碳青霉烯类耐药人群的临床治疗成功率和微生物清除率均优于对照组（注射用亚胺西瑞）；安全性良好：整体耐受性良好，安全性特征符合预期。参考资料：[1]信诺维1类新药注射用亚胺西福申报上市获受理！From https://mp.weixin.qq.com/s/d34xkqY1RBnV7INk8CXE4w免责声明：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期微生物疗法

100 项与阿维巴坦钠相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB09060

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
菌血症	临床3期	美国	Pfizer Inc.	2020-12-25
菌血症	临床3期	希腊	Pfizer Inc.	2020-12-25
菌血症	临床3期	印度	Pfizer Inc.	2020-12-25
菌血症	临床3期	俄罗斯	Pfizer Inc.	2020-12-25
复杂腹腔感染	临床3期	美国	Pfizer Inc.	2020-12-25
复杂腹腔感染	临床3期	希腊	Pfizer Inc.	2020-12-25
复杂腹腔感染	临床3期	印度	Pfizer Inc.	2020-12-25
复杂腹腔感染	临床3期	俄罗斯	Pfizer Inc.	2020-12-25
复杂下尿路感染	临床3期	美国	Pfizer Inc.	2020-12-25
复杂下尿路感染	临床3期	希腊	Pfizer Inc.	2020-12-25