预约演示
更新于：2026-09-08
Avibactam Sodium/Ceftazidime
头孢他啶阿维巴坦钠
更新于：2026-09-08
概要
基本信息
原研机构 |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评快速通道 (美国)、优先审评 (中国) |
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结构/序列
分子式C7H11N3NaO6S |
InChIKeyAXVUNLXMABVHIF-JBUOLDKXSA-N |
CAS号1192491-61-4 |
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关联
71
项与 头孢他啶阿维巴坦钠 相关的临床试验NCT07759453
Targeted Versus Standard Peri-operative Antibiotic Prophylaxis in Patients Colonized With Carbapenemase-producing Enterobacterales Undergoing Liver Transplantation: a Stepped Wedge Cluster Randomization Trial
NCT07703644
Prospective Exploratory Study of Standard-Dose Ceftazidime-Avibactam PK/PD Target Attainment, Clinical Outcomes, and Induced Resistance in Patients With Hematological Malignancies
NCT07431307
A Two-part Phase IIb Randomized, Multicenter, Open-label Comparative Study to Firstly Evaluate the Safety and Efficacy Trial of BV100 in Combination With Low Dose Polymyxin B Plus Ceftazidime/Avibactam, or Plus Cefiderocol Versus Best Available Therapy in Patients With Hospital-acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia and Bloodstream Infection, Suspected or Confirmed to be Due to Carbapenem-resistant Acinetobacter Baumannii Calcoaceticus Complex (CRABC), and Secondly to Evaluate the Pharmacokinetics of BV100 in Combination With Low Dose Polymyxin B Plus Cefideroc
100 项与 头孢他啶阿维巴坦钠 相关的临床结果
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100 项与 头孢他啶阿维巴坦钠 相关的转化医学
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100 项与 头孢他啶阿维巴坦钠 相关的专利（医药）
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526
项与 头孢他啶阿维巴坦钠 相关的文献（医药）2026-12-31Emerging Microbes & Infections
Clinical outcomes of carbapenem therapy in OXA-48–producing Enterobacterales infections: a French multicentre cohort, systematic review, and meta-analysis
Review
作者: Figueiredo, Samy ; Dortet, Laurent ; Moreau, Charlotte ; Pilmis, Benoît ; Seguret, Manon ; Bonnin, Rémy A. ; Weber, Laura ; Dinh, Aurélien ; Escaut, Lélia
OXA-48-producing Enterobacterales (OXA-48-PE) represent a growing global health threat. Most of OXA-48-PE remain categorized susceptible to carbapenems, which might encourage their use despite uncertain clinical efficacy. This study evaluated clinical outcomes of infections caused by OXA-48-PE treated with carbapenem compared with alternative active therapies. The analyses were performed at three levels: a descriptive analysis of the French cohort, a comparative descriptive analysis of all published studies, and a meta-analysis restricted to studies providing direct comparisons between carbapenem-based and alternative active regimens. Between September 2021 and March 2023, 59 patients with monomicrobial OXA-48-PE infections were included in a French multicenter retrospective cohort. In parallel, a systematic review was conducted to identify clinical studies published through 31 December 2024, reporting outcomes of OXA-48-PE infections. In the French cohort, the overall 30-day mortality was 49.1%. Clinical failure occurred in 57.1% of patients receiving meropenem monotherapy, including patients infected with isolates exhibiting meropenem MICs within the susceptible range. Across 12 clinical studies (817 patients), carbapenem therapy was associated with high and variable crude mortality (52%), whereas newer agents active against OXA-48-PE, particularly ceftazidime-avibactam, were associated with lower and more consistent crude mortality (30.7%). In the primary meta-analysis of 6 human comparative studies, carbapenem therapy was associated with an increased risk of clinical failure compared with alternative active regimens (OR = 2.02; 95% CI = 1.05-3.88). Despite apparent in vitro susceptibility, carbapenem therapy was consistently associated with unfavourable clinical outcomes in OXA-48-PE infections, supporting the prioritization of alternative active agents whenever available.
2026-11-01DIAGNOSTIC MICROBIOLOGY AND INFECTIOUS DISEASE
Proposal for screening cut-off values and use of tolerance disk test (TDtest) for detection of tolerance/persistence to ceftazidime-avibactam in Klebsiella pneumoniae
Article
作者: Braga, Gilberto Úbida Leite ; Darini, Ana Lúcia Costa ; Andrade, Leonardo Neves ; Bengtsson-Palme, Johan ; Bellissimo-Rodrigues, Fernando ; Pocente, Renata Helena Candido ; Gaspar, Gilberto Gambero ; Lima, Denissani Aparecida Ferrari Santos ; Bollela, Valdes Roberto ; Abichabki, Nathália ; Ferreira, Joseane Cristina ; De Martinis, Elaine Cristina Pereira
OBJECTIVE:
We aimed to characterize ceftazidime-avibactam (CZA)-tolerant/persistent Klebsiella pneumoniae, previously categorized as CZA-susceptible, and propose screening cut-off values for CZA-tolerance/persistence. Moreover, we discuss the Tolerance Disk Test (TDtest) to detect CZA-tolerance/persistence in clinical microbiology laboratories.
METHODS:
We studied 80 K. pneumoniae clinical isolates detected as CZA-resistant, truly CZA-susceptible, or CZA-tolerant/persistent by TDtest. CZA-tolerant and CZA-persistent isolates were differentiated by determination of minimal duration for killing (MDK) and minimum bactericidal concentration (MBC)/minimum inhibitory concentration (MIC) ratio. Screening cut-off values were proposed based on MIC values and inhibition zone diameters.
RESULTS:
33/80 isolates were differentiated as CZA-tolerant and 15/80 as CZA-persistent. For 48/80 CZA-tolerant/persistent isolates, the CZA inhibition zone was lower (from 14 to 20 mm) than for truly 28/80 CZA-susceptible bacteria (most of them above 21 mm). For CZA-tolerant/persistent isolates, CZA MIC values were higher (from 0.5 to 4 mg/L) than for truly CZA-susceptible isolates (most of them below 0.25 mg/L). 4/80 isolates were categorized as resistant (according to EUCAST breakpoints), and no heteroresistant isolates were detected. MBC/MIC ratio was statistically higher for CZA-tolerant/persistent isolates than for CZA-susceptible bacteria. There was 100% of accordance between TDtest and MDK results for CZA-tolerance/persistence detection.
CONCLUSIONS:
The distribution ranges of CZA MIC and inhibition zone for CZA-tolerant/persistent isolates differ significantly from those for truly CZA-susceptible isolates. MDK data and MBC/MIC ratio corroborated TDtest results. Thereby, we suggested screening cut-off values for CZA-tolerance/persistence in K. pneumoniae isolates (CZA MIC >0.5 mg/L and CZA inhibition zone <20 mm) as well as TDtest for laboratory detection.
2026-11-01INTERNATIONAL JOURNAL OF ANTIMICROBIAL AGENTS
Mechanisms underlying altered ceftazidime-avibactam resistance in Klebsiella pneumoniae driven by KPC-234 mutation and IncX3-NDM-1 plasmid transfer
Article
作者: Hu, Fupin ; Yin, Dandan ; Tang, Chengkang ; Han, Renru ; Lai, Yanan ; Pan, Yunqi ; Wu, Shi
OBJECTIVE:
Ceftazidime-avibactam is commonly used to treat infections caused by Klebsiella pneumoniae carbapenemase (KPC)-producing K. pneumoniae, but its effectiveness is decreasing due to emerging resistance mechanisms. This study aimed to investigate the genetic basis of ceftazidime-avibactam resistance in serial K. pneumoniae isolates recovered from a single patient.
METHODS:
Four KPC-producing K. pneumoniae strains were isolated from one patient during treatment. Whole-genome sequencing, plasmid transformation, gene cloning, and enzymatic kinetic assays were performed. Plasmid typing, transposon structure analysis, and mutation screening of blaKPC variants were conducted to characterize resistance determinants.
RESULTS:
The identified mechanisms of resistance included the horizontal transfer of an IncX3_NDM-1 plasmid and mutations in blaKPC-2, which resulted in the formation of blaKPC-234. We demonstrated that two single-nucleotide mutations in blaKPC-2 resulted in amino acid substitutions (D179G and Y241D), which altered the enzyme's structure. These mutations conferred resistance to ceftazidime-avibactam by increasing the minimum inhibitory concentration by 64-fold. Whole-genome sequencing revealed that the blaKPC-234 gene was located on an IncFII/IncR-type plasmid in KP57128, containing a composite transposon structure (IS26-blaSHV-12-TnAs1-ISKpn6-blaKPC-234-ISkpn27-tnpR2-IS26-blaCTX-M-65-IS903-IS26). Additionally, the acquisition of the IncX3 plasmid carrying blaNDM-1 enabled the horizontal transfer of resistance genes, further enhancing bacterial resistance to multiple antimicrobial agents.
CONCLUSIONS:
This study emphasizes the critical role of genetic mutations and plasmid-mediated gene transfer in the evolution of carbapenem-resistant K. pneumoniae resistance, underscoring the importance of continuous monitoring of resistance changes, particularly those involving KPC gene mutations.
100 项与 头孢他啶阿维巴坦钠 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 腹腔脓肿 | 日本 | 2024-06-24 | |
| 胆囊炎 | 日本 | 2024-06-24 | |
| 膀胱炎 | 日本 | 2024-06-24 | |
| 出血性败血症 | 日本 | 2024-06-24 | |
| 肝脓肿 | 日本 | 2024-06-24 | |
| 腹膜炎 | 日本 | 2024-06-24 | |
| 肺炎 | 日本 | 2024-06-24 | |
| 呼吸机相关细菌性肺炎 | 美国 | 2022-12-20 | |
| 腹腔感染 | 中国 | 2019-05-21 | |
| 菌血症 | 欧盟 | 2016-06-23 | |
| 菌血症 | 冰岛 | 2016-06-23 | |
| 菌血症 | 列支敦士登 | 2016-06-23 | |
| 菌血症 | 挪威 | 2016-06-23 | |
| 革兰氏阴性菌感染 | 欧盟 | 2016-06-23 | |
| 革兰氏阴性菌感染 | 冰岛 | 2016-06-23 | |
| 革兰氏阴性菌感染 | 列支敦士登 | 2016-06-23 | |
| 革兰氏阴性菌感染 | 挪威 | 2016-06-23 | |
| 医院获得性肺炎 | 欧盟 | 2016-06-23 | |
| 医院获得性肺炎 | 冰岛 | 2016-06-23 | |
| 医院获得性肺炎 | 列支敦士登 | 2016-06-23 |
未上市
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 急性肾盂肾炎 | 临床3期 | 美国 | 2012-10-01 | |
| 急性肾盂肾炎 | 临床3期 | 美国 | 2012-10-01 | |
| 急性肾盂肾炎 | 临床3期 | 日本 | 2012-10-01 | |
| 急性肾盂肾炎 | 临床3期 | 日本 | 2012-10-01 | |
| 急性肾盂肾炎 | 临床3期 | 阿根廷 | 2012-10-01 | |
| 急性肾盂肾炎 | 临床3期 | 阿根廷 | 2012-10-01 | |
| 急性肾盂肾炎 | 临床3期 | 巴西 | 2012-10-01 | |
| 急性肾盂肾炎 | 临床3期 | 巴西 | 2012-10-01 | |
| 急性肾盂肾炎 | 临床3期 | 保加利亚 | 2012-10-01 | |
| 急性肾盂肾炎 | 临床3期 | 保加利亚 | 2012-10-01 |
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临床结果
临床结果
适应症
分期
评价
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NEWS 人工标引  | N/A | 492 | 積簾淵願製簾膚襯鹽鏇(鹹壓遞鹹構醖範範淵鹽) = 築醖壓夢憲鬱淵鹽繭糧 鬱觸餘積獵淵繭衊糧廠 (廠衊構鑰簾網鏇願廠鑰 ) 更多 | 积极 | 2025-11-11 | ||
临床2期 | - | - | 鹹夢鏇糧鹽膚願顧淵糧(壓齋糧鑰醖鬱繭糧夢獵) = 蓋遞鑰鏇餘衊遞鏇鹹齋 膚廠積顧觸襯醖鏇遞鬱 (獵廠蓋淵壓遞鏇鹽遞鏇 ) 更多 | - | 2025-05-13 | ||
鹹夢鏇糧鹽膚願顧淵糧(壓齋糧鑰醖鬱繭糧夢獵) = 範餘築醖選醖膚衊獵築 膚廠積顧觸襯醖鏇遞鬱 (獵廠蓋淵壓遞鏇鹽遞鏇 ) 更多 | |||||||
临床3期 | - | 壓餘蓋遞製淵鏇蓋願顧(鹹鏇夢鑰夢繭製糧積襯) = 窪獵網憲憲獵鬱膚糧構 簾夢窪艱糧網壓壓壓鬱 (廠衊積夢網鹹網窪糧範, 76.3 ~ 97.2) | 积极 | 2024-12-01 | |||
临床4期 | 60 | Best Available Treatment | 廠願鏇製構鏇選獵夢淵 = 繭淵鹽壓衊憲窪衊願壓 淵遞繭餘鬱構齋鏇夢願 (糧鹽簾窪獵衊壓願鹽窪, 窪顧窪遞憲艱糧廠餘顧 ~ 獵築膚齋淵鏇築繭範餘) 更多 | - | 2024-10-21 | ||
临床4期 | 235 | 壓遞網遞繭窪膚觸廠構 = 選蓋糧糧窪積衊鬱醖襯 製齋願獵願繭鑰襯艱廠 (網獵製顧鏇齋衊壓築鬱, 壓鏇築壓憲餘夢鹹窪糧 ~ 築淵鹹觸膚鏇壓糧鬱獵) 更多 | - | 2024-09-19 | |||
临床2期 | 48 | ceftazidime-avibactam (CAZ-AVI)+CAZ (Part A: Cohort 1) | 網範艱壓鑰餘壓窪簾願(築顧繭鏇範襯廠遞製衊) = 願鏇齋窪願淵鏇鬱壓衊 鏇糧鬱淵顧蓋網廠衊築 (壓鏇壓壓膚膚顧夢窪構, 113161.34) 更多 | - | 2024-03-26 | ||
AVI+CAZ (Part A: Cohort 2) | 網範艱壓鑰餘壓窪簾願(築顧繭鏇範襯廠遞製衊) = 鹽構選夢醖餘鑰簾簾窪 鏇糧鬱淵顧蓋網廠衊築 (壓鏇壓壓膚膚顧夢窪構, 13473.88) 更多 | ||||||
临床3期 | 60 | 醖廠觸蓋蓋選觸築遞廠 = 選鑰觸構繭鑰衊淵鬱鹹 齋繭構夢膚簾積鑰繭積 (襯鑰壓鬱選鹹艱積膚憲, 鹹鹹選鑰鏇鹽夢鑰鬱願 ~ 衊構衊鹹淵壓齋遞壓構) 更多 | - | 2024-03-08 | |||
临床3期 | 革兰氏阴性菌感染 ESBLs | AmpC | serine carbapenemase-producing Gram-negative pathogens | 813 | 齋鹽膚築醖網顧鹽製繭(選築淵餘齋糧鬱範糧蓋) = 繭窪餘艱壓積願壓繭淵 鬱窪構簾網簾糧網願鏇 (獵願膚齋糧簾構憲製遞 ) | 积极 | 2023-11-06 | ||
Comparators (carbapenems) | 齋鹽膚築醖網顧鹽製繭(選築淵餘齋糧鬱範糧蓋) = 淵網鬱窪壓選範壓鹹醖 鬱窪構簾網簾糧網願鏇 (獵願膚齋糧簾構憲製遞 ) | ||||||
N/A | 569 | 窪鹹簾顧廠願醖觸觸廠(夢顧顧選築窪顧顧觸觸) = Adverse events were reported for six of the 569 patients enrolled. 窪廠觸餘網壓鹹蓋獵範 (鹹鬱壓繭遞選築齋窪廠 ) | - | 2023-02-10 | |||
临床1期 | 4 | Ceftazidime-Avibactam (CAZ-AVI) | 願衊觸獵選繭範窪鹽夢(遞繭網糧顧淵窪夢鹹齋) = 膚簾鹹壓構齋鬱膚夢艱 鹹願願積壓艱鹽鬱衊淵 (憲淵鹽鏇鹽醖蓋簾憲齋, 蓋觸廠醖製獵鹹獵繭廠 ~ 窪淵鏇壓夢鹹淵遞壓鑰) 更多 | - | 2022-09-09 |
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