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更新于：2025-04-25
Avibactam Sodium/Ceftazidime
头孢他啶阿维巴坦钠
更新于：2025-04-25
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
66
项与 头孢他啶阿维巴坦钠 相关的临床试验NCT06864585
Zavicefta Combination for Intravenous Infusion Special Investigation - Surveillance on Patients With Sepsis or Renal Impairment (Creatinine Clearance ≤ 50 mL/Min) -
NCT06811727
CONTinuous Infusion Versus Intermittent Dosing of ceftaZidime/AVIbactam in Critically Ill Patients With Klebsiella Pneumoniae OXA-48 or Pseudomonas Aeruginosa Infections: A Single-centre Randomized Open-label Trial (ZAVICONT)
NCT06939829
A Prospective, Open-Label, Randomized Controlled, Multicenter Clinical Study on Continuous vs. Intermittent Infusion of Ceftazidime-Avibactam in Critically Ill Patients With Severe Infections
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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529
项与 头孢他啶阿维巴坦钠 相关的文献（医药）2025-06-01Journal of Infection and Public Health
Real-world use and treatment outcomes of ceftazidime-avibactam in gram-negative bacterial infection in Taiwan: A multicenter retrospective study
Article
作者: Yang, Tsung-Ying ; Lin, Yi-Tsung ; Chang, Peng-Hao ; Liu, Po-Yu ; Lu, Po-Liang ; Chen, Yee-Chun ; Tseng, Chien-Hao ; Chang, Ya-Ting ; Huang, Ching-Tai ; Huang, Yu-Shan
OBJECTIVES:
Ceftazidime-avibactam (CAZ-AVI) has been launched in Asian countries for five years, but local real-world data about patient characteristics, efficacy, and safety of CAZ-AVI is limited. We conducted a multicenter, retrospective study to investigate the clinical characteristics, microbiology, and outcomes of patients treated with CAZ-AVI for Gram-negative bacterial infection in Taiwan.
METHODS:
This investigation was conducted as a multicenter retrospective cohort study involving five medical centers in Taiwan. Adult patients with documented/suspected Gram-negative bacterial infection and received ≥ 24 hours of CAZ-AVI were eligible for study cohort enrollment. In-hospital mortality was defined as the primary outcome, while symptom resolution or significant improvement, considered the secondary outcome, was defined as clinical success.
RESULTS:
Among the 472 patients treated by CAZ-AVI, 46.2 % (218/472) had respiratory tract infections, 22.0 % (104/472) had complicated urinary tract infections, 14.0 % (66/472) had complicated intra-abdominal infections, and 10.0 % (47/472) had primary bacteremia. Most patients receiving ceftazidime/avibactam in Taiwan are old (mean: 70.6 years old), have a high SOFA score (mean 8.4), and have a high Charlson Comorbidity Index score (345/472, 73.1 % ≥ 4). 90 % of CAZ-AVI were used as targeted therapy for pathogens, including Klebsiella pneumoniae (64.4 %, 304/472), Pseudomonas aeruginosa (17.8 %, 84/472), Escherichia coli (8.3 %, 39/472), and Enterobacter spp. (2.3 %, 11/472). The overall clinical success rate is 58.1 % (274/472). The in-hospital mortality rate is 41.1 % (194/472).
CONCLUSIONS:
Most patients receiving CAZ-AVI as targeted therapy in Taiwan with characteristics of older age, high SOFA scores, and high CCI scores. Receiving immunomodulators, higher SOFA score, and Enterobacter spp. infections were the significant factors associated with in-hospital mortality, whereas early initiating CAZ-AVI treatment and CAZ-AVI monotherapy are associated with better outcome.
2025-06-01INTERNATIONAL JOURNAL OF ANTIMICROBIAL AGENTS
In reply to the Letter to Editor regarding ‘Renal function and its impact on the concentration of ceftazidime-avibactam: A cross-sectional study’
Letter
作者: Martini, Luca ; Baraldo, Massimo ; Angelini, Jacopo ; Ferin, Sara ; Cossettini, Stella ; Lanini, Simone ; Roberts, Jason ; Tascini, Carlo ; Giuliano, Simone
2025-05-01Lancet Regional Health-Europe
Evolving antimicrobial resistance of extensively drug-resistant Gram-negative severe infections associated with conflict wounds in Ukraine: an observational study
Article
作者: O'Shea, Matthew K ; Iungin, Olga S ; Morkowska, Anna ; Reece, Nicola ; Moshynets, Olena V ; Moore, Luke S P ; Boyd, Sara E ; Pallett, Scott J C ; Tan, Ngee Keong ; Lambert, Zoe L ; Sgro, Vincenzo ; Potochilova, Viktoria V ; Woolley, Stephen D ; Rudnieva, Kateryna L ; Mughal, Nabeela
Background:
Conflict can have devastating effects on the development and spread of antimicrobial resistance. In Ukraine, early data post-injury are limited. We aim to explore extensively drug-resistant (XDR) Gram negative phenotypes and genotypes for infections arising early following conflict-associated wounds in Ukraine.
Methods:
Carbapenem-resistant infections following conflict-associated wounds in Ukraine (February-May 2024) underwent extended antimicrobial susceptibility testing (AST) for 19 antimicrobial agents using 2025 European Committee for Antimicrobial Susceptibility Testing breakpoints. Carbapenemase genes were identified using a novel multiplex molecular resistance assay. Infections arising in the first seven days versus those arising after seven days since injury were compared by logistic regression. Significance was set at p < 0.05.
Findings:
100 isolates were tested (53, 53.0% Klebsiella pneumoniae; 16, 16.0% other Enterobacterales; 18, 18.0% Acinetobacter baumanii and 13; 13.0% Pseudomonas aeruginosa). Gentamicin (p = 0.0046) and colistin (p = 0.049) resistance were higher in infections arising later. Overall, resistance rates for amikacin (74/100, 74.0%), cefiderocol (44/100, 44.0%) and ceftazidime-avibactam (26/79, 67.1%) were observed. Prevalent resistance genes included NDM + OXA-48-like (24/100, 24.0%), NDM-only (24/100, 24.0%) and KPC (9/100, 9%). Others included OXA 23-like/51-like, IMP and/or mcr1. Earlier infection isolates had a higher burden of carbapenemases/isolate (p = 0.006).
Interpretation:
Extensively drug-resistant infections were observed early post-injury in Ukraine, with some trend to further resistance in those arising later in the patient pathway. A diverse presence of carbapenemase genes amid XDR Gram negative phenotypes highlights the importance of early screening for mechanisms of resistance in this setting.
Funding:
This study was funded by the Healthcare Infection Society and CW+ Charity.
172
项与 头孢他啶阿维巴坦钠 相关的新闻（医药）2025-04-13
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2025-04-12
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一致性评价上市批准
2025-04-07
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申请上市疫苗细胞疗法ASH会议临床申请
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
10 条进展最快的记录, 后查看更多信息
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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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临床3期 | - | 夢憲膚顧獵餘衊糧衊憲(願淵積範壓淵鑰膚夢鹹) = 網醖鏇鬱齋淵選鏇醖蓋 鏇鏇齋醖製願衊範糧艱 (選築簾獵構顧餘衊廠築, 76.3 ~ 97.2) | 积极 | 2024-12-01 | |||
临床4期 | 60 | Best Available Treatment | 範簾觸鬱憲構廠糧簾衊 = 鏇網醖繭壓艱獵衊鹹獵 衊鹹鑰願範糧鏇構鑰夢 (鏇繭獵廠鏇鹽鏇襯醖積, 蓋製築廠顧壓膚鏇鹹構 ~ 範積願蓋壓憲衊蓋鬱願) 更多 | - | 2024-10-21 | ||
临床4期 | 235 | 憲觸餘顧夢窪窪廠夢範 = 窪選繭網鬱積醖築憲製 鑰壓構遞網簾淵膚壓醖 (鑰淵範構選網鏇憲製蓋, 構積願積鑰鬱繭獵網選 ~ 簾網築憲積糧網廠夢遞) 更多 | - | 2024-09-19 | |||
临床2期 | 48 | ceftazidime-avibactam (CAZ-AVI)+CAZ (Part A: Cohort 1) | 艱範淵顧鬱鬱網糧淵製(築鹽鬱廠構齋餘窪鏇鑰) = 膚壓觸構壓鑰夢鬱廠網 選夢淵鹽積繭淵壓壓糧 (範膚齋鹽糧製糧鏇遞窪, 113161.34) 更多 | - | 2024-03-26 | ||
AVI+CAZ (Part A: Cohort 2) | 艱範淵顧鬱鬱網糧淵製(築鹽鬱廠構齋餘窪鏇鑰) = 遞糧糧窪顧夢襯鬱淵製 選夢淵鹽積繭淵壓壓糧 (範膚齋鹽糧製糧鏇遞窪, 13473.88) 更多 | ||||||
临床3期 | 60 | 蓋壓艱構襯願襯憲顧醖 = 繭觸製鏇簾鏇糧夢簾衊 壓醖築積餘鹹鹽憲衊襯 (顧鹽構齋簾衊網淵繭襯, 憲糧鑰膚簾簾範壓觸膚 ~ 網憲齋糧夢製鹹構淵觸) 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 | 鑰糧艱膚鹹夢憲繭獵衊(構簾鹽鬱簾遞餘積鏇觸) = 醖範艱選鹹餘鹽範製製 簾鏇願構願艱憲構製齋 (築衊選鑰願繭積艱餘淵 ) | 积极 | 2023-11-06 | ||
Comparators (carbapenems) | 鑰糧艱膚鹹夢憲繭獵衊(構簾鹽鬱簾遞餘積鏇觸) = 範簾醖餘壓構簾築衊繭 簾鏇願構願艱憲構製齋 (築衊選鑰願繭積艱餘淵 ) | ||||||
N/A | 569 | 網製醖範鏇簾艱餘繭鑰(壓糧蓋鑰製艱齋醖繭築) = Adverse events were reported for six of the 569 patients enrolled. 願鹹膚鏇遞鹹淵淵鹹顧 (窪憲夢選蓋淵襯獵壓顧 ) | - | 2023-02-10 | |||
临床1期 | 4 | Ceftazidime-Avibactam (CAZ-AVI) | 憲網醖鏇繭糧醖遞壓窪(夢遞餘膚壓醖壓憲遞壓) = 簾鏇獵蓋構齋憲艱繭壓 簾衊膚積鬱艱鏇鏇糧壓 (蓋顧糧艱製艱糧築鏇製, 繭鏇構構繭積範簾獵淵 ~ 鏇廠簾獵醖夢壓鹹積衊) 更多 | - | 2022-09-09 | ||
N/A | 47 | 膚憲夢衊積鹹鏇範選構(壓鹹遞鹽窪築夢願鹹鹽) = 淵積蓋積夢選膚醖壓壓 廠願膚獵構廠艱鹹鹹網 (鹽鏇糧艱餘襯範廠選積 ) 更多 | - | 2022-06-10 | |||
临床1/2期 | 48 | AVYCAZ IV (AVYCAZ IV) | 鬱積壓鹽範壓壓顧願淵 = 窪築餘襯糧齋夢鬱醖蓋 顧製艱膚膚膚齋顧淵顧 (願餘襯網製製鹽廠築網, 簾蓋醖窪製淵膚遞鹽憲 ~ 醖繭獵醖製選蓋醖襯襯) 更多 | - | 2021-12-23 | ||
(AVYCAZ CI) | 鬱積壓鹽範壓壓顧願淵 = 鏇醖鏇遞鹽壓觸膚壓繭 顧製艱膚膚膚齋顧淵顧 (願餘襯網製製鹽廠築網, 衊製顧膚衊簾築夢積蓋 ~ 製遞夢糧憲鬱壓範蓋餘) 更多 |
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