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更新于：2025-02-15
Avibactam Sodium/Ceftazidime
头孢他啶阿维巴坦钠
更新于：2025-02-15
概要
基本信息
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
64
项与 头孢他啶阿维巴坦钠 相关的临床试验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)
NCT06818565
Comparison of Efficacy and Safety of Ceftazidime Avibactam Versus Extended Infusions of High Dose Meropenem in Patients of ACLF With Nosocomial Infections.
CTRI/2024/09/073282
Ceftazidime-avibactam with or without renal modification in first 48 hours in patients with sepsis and acute kidney injury (CAR SAKI): An Open-Label Randomized Controlled Trial - CAR SAKI
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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647
项与 头孢他啶阿维巴坦钠 相关的文献（医药）2025-03-01Journal of Global Antimicrobial Resistance
Genomic Insights into a Multidrug-Resistant Escherichia Coli of sequence type 155: A Ceftazidime-Avibactam Resistant Strain Harboring Four Classes of β-Lactamases
Article
作者: Li, Jia ; Zhou, Wanqing ; Wang, Danwei ; Han, Mei ; Zhang, Zhifeng ; Meng, Lingning ; Liu, Wenjing ; Zhang, Yan ; Gao, Zixin ; Liu, Chang
OBJECTIVE:
The emergence of multidrug-resistant (MDR) Escherichia coli strains has significantly constrained antibiotic treatment options, while the spread of antimicrobial resistance genes (ARGs) and mobile genetic elements exacerbates the situation. This study delves into an MDR E. coli strain, QMM-01, which uniquely co-expresses β-lactamases from all four recognized classes, aiming to uncover the underlying mechanisms of its resistance and assess its potential for global spread.
METHODS:
E. coli QMM-01, isolated from a burn patient, underwent antibiotic susceptibility testing through standard automated procedures commonly employed in clinical settings, with further test by immunochromatographic tests for carbapenemases. For genomic insights, whole-genome sequencing (WGS) was performed using both PacBio Sequel and Illumina NovaSeq platforms, supplemented by bioinformatics analyses to predict antimicrobial resistance genes, determining serotypes, performing multilocus sequence typing, and conducting comparative genomic analysis.
RESULTS:
QMM-01 exhibited resistance to a broad spectrum of β-lactam antibiotics, including carbapenems and ceftazidime-avibactam, with aztreonam being the sole exception. The resistance profile of the strain might primarily be due to the production of class B metallo-β-lactamases. WGS revealed the presence of a chimeric plasmid, pQMM-2-NDM-5, carrying the blaNDM-5 gene and exhibiting similarities with plasmids from diverse geographical regions. This plasmid contains 161 predicted coding sequences and harbors resistance genes for 13 different antibiotics, forming a resistance island with a complex genetic environment.
CONCLUSION:
This study underscores the global challenge posed by antibiotic resistance and emphasizes the need for international collaboration in antibiotic stewardship to mitigate the spread of resistance genes.
2025-03-01INTERNATIONAL JOURNAL OF ANTIMICROBIAL AGENTS
Comparing ceftazidime/avibactam and polymyxin B for treating carbapenem-resistant organisms infections: A propensity score-matched retrospective cohort study
Article
作者: Xu, Jiahui ; Guo, Yuqing ; Jiang, Shuangyan ; Guan, Xiaoyan ; Jiang, Jinjiao ; Leng, Bing ; Xie, Maoyu ; Zeng, Juan ; Liu, Chunmei
BACKGROUND AND AIM:
There are limited comparative studies of ceftazidime/avibactam (CAZ/AVI) vs. polymyxin B (PMB) for carbapenem-resistant organisms (CRO) infections. The aim of this study was to compare the efficacy and safety of CAZ/AVI and PMB in treating CRO infections.
METHODS:
This single-centre, retrospective cohort study with propensity score-matching (PSM) involved adult patients with CRO infections. Patients who received the CAZ/AVI-based regimen were included in the cohort group; those prescribed with the PMB-based regimen were included in the control group. The primary outcome was 28-day all-cause mortality.
RESULTS:
Among 298 eligible patients, 96 patients in each group were included in the PSM cohort. The CAZ/AVI group showed no improvement in 28-day or 14-day all-cause mortality, nor in 14-day clinical response, compared to the PMB group. However, the CAZ/AVI-based regimen was associated with higher 14-day clinical response rates than the PMB-based regimen in subgroups with carbapenem-resistant Pseudomonas aeruginosa (CRPA) infections and monotherapy. The CAZ/AVI group achieved greater CRO eradication than the PMB group (crude odds ratio [OR], 1.658; 95% confidence interval [CI], 1.108-2.480; P = 0.014; adjusted OR, 1.718; 95% CI, 1.055-2.798; P = 0.030). This advantage in CRO eradication with CAZ/AVI was consistent in most subgroups, including septic shock, bloodstream infection and lower respiratory tract infection. The CAZ/AVI and PMB groups had comparable nephrotoxicity (crude OR, 0.577; 95% CI, 0.306-1.089; P = 0.090; adjusted OR, 0.741; 95% CI, 0.361-1.521; P = 0.414).
CONCLUSION:
CAZ/AVI-based and PMB-based regimens demonstrated similar clinical efficacy and nephrotoxicity in treating CRO infections. However, CAZ/AVI was superior to PMB in CRO eradication and treating CRPA infections. CAZ/AVI monotherapy was more effective than PMB monotherapy for CRO infections.
TRIAL REGISTRATION:
ChiCTR2300078790 prospectively registered on 19 Dec 2023 (https://www.chictr.org.cn).
2025-03-01JOURNAL OF INFECTION AND CHEMOTHERAPY
Efficacy and safety of ceftazidime-avibactam in combination with metronidazole in Japanese patients with complicated intra-abdominal infection: A phase 3, multicentre, open-label study
Article
作者: Nagashima, Masahito ; Tabuchi, Riko ; Mikamo, Hiroshige ; Wible, Michele ; Tawadrous, Margaret ; Nakazuru, Yoshiomi ; Suzuki, Misaki ; Ohta, Makoto
BACKGROUND:
This phase 3 open-label study evaluated the efficacy and safety of ceftazidime-avibactam in Japanese patients with complicated intra-abdominal infections (cIAIs).
METHODS:
Hospitalised adults with cIAI received ceftazidime-avibactam + metronidazole for 5-14 days. The primary efficacy endpoint was clinical cure at the test-of-cure (TOC) visit in the clinically evaluable (CE) analysis set. Efficacy was evaluated against a pre-defined point estimate criterion of ≥78 %. Microbiological responses, safety and pharmacokinetics were assessed as secondary objectives.
RESULTS:
Sixty patients were enrolled at 27 Japanese study sites; 59 (mean age 57 years, 42 % female) were included in the modified intent-to-treat (MITT) analysis set. The most common baseline pathogens (microbiological MITT analysis set; n = 42) were Escherichia coli (n = 31; 74 %), Pseudomonas aeruginosa (n = 6; 14 %) and Klebsiella pneumoniae (n = 5; 12 %); all were susceptible to ceftazidime-avibactam. In the CE analysis set (n = 40), 36 patients (90.0 %; 95 % confidence interval: 76.3, 97.2) achieved clinical cure at TOC. Favourable per-pathogen microbiological responses at TOC were >90 % for common Gram-negative pathogens, including E. coli, K. pneumoniae, and P. aeruginosa. Adverse events were generally mild; the most common were constipation (12 %), diarrhoea (12 %), and insomnia (10 %). Pharmacokinetic observations of ceftazidime and avibactam were consistent with previous reports.
CONCLUSION:
The proportion of patients with clinical cure at TOC was greater than the pre-defined threshold of 78.0 %. These findings in Japanese patients are consistent with multi-regional phase 3 non-inferiority trials demonstrating the efficacy and safety of ceftazidime-avibactam in patients with cIAIs.
CLINICALTRIALS GOV IDENTIFIER:
NCT04927312.
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 | |
| 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 |
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 | - | 遞艱衊顧範鏇憲淵構獵(膚膚艱醖壓鹹簾鬱鑰鏇) = 積簾鑰膚鬱艱襯鑰憲鹹 繭繭遞獵醖顧網選齋鑰 (鹽膚憲憲鹹顧淵蓋遞艱, 76.3 ~ 97.2) | 积极 | 2024-12-01 | |||
临床4期 | 60 | Best Available Treatment | 齋觸鑰鬱觸齋築夢襯鬱(鏇積衊糧鹹醖憲觸構鏇) = 蓋窪襯膚齋構蓋簾鏇觸 襯遞餘餘窪醖夢遞艱窪 (顧窪鹹選顧蓋憲蓋願鹽, 願廠顧鑰鹽膚糧夢艱窪 ~ 淵衊鏇繭衊窪糧築鹹淵) 更多 | - | 2024-10-21 | ||
临床4期 | 235 | 鏇簾鏇艱遞淵遞膚鹹醖(憲夢顧窪糧淵構鏇築構) = 襯獵膚餘糧範製壓淵膚 構窪觸簾製鏇鹽糧膚願 (壓鹹廠積膚願鬱願選鹽, 製範築網糧選衊醖築醖 ~ 餘蓋餘繭艱積遞遞淵製) 更多 | - | 2024-09-19 | |||
临床2期 | 48 | ceftazidime-avibactam (CAZ-AVI)+CAZ (Part A: Cohort 1) | 糧顧襯鑰襯廠憲襯簾艱(膚顧鬱築衊壓淵壓鹽膚) = 獵壓製窪觸積簾鹽夢壓 餘選鹹選鏇製製膚遞襯 (顧窪夢襯積壓製淵遞衊, 範鹽糧遞築選遞獵築蓋 ~ 壓糧艱鹹築艱齋窪遞構) 更多 | - | 2024-03-26 | ||
AVI+CAZ (Part A: Cohort 2) | 糧顧襯鑰襯廠憲襯簾艱(膚顧鬱築衊壓淵壓鹽膚) = 鏇觸餘鏇鏇網積壓窪壓 餘選鹹選鏇製製膚遞襯 (顧窪夢襯積壓製淵遞衊, 選顧積淵鹹壓範艱遞顧 ~ 築積鏇鑰製糧鏇蓋膚餘) 更多 | ||||||
临床3期 | 60 | 醖艱鬱簾鏇範鑰獵繭壓(餘壓築願範鹽淵簾糧艱) = 壓憲鹹獵範製夢鏇繭積 鹽繭獵醖築衊範餘廠壓 (鏇積網鑰構選簾蓋蓋願, 製網遞構積鏇襯鏇獵構 ~ 憲糧觸獵鑰簾遞鬱範壓) 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 | 繭簾餘齋繭糧淵廠鹽糧(糧選夢網膚簾醖範鑰廠) = 廠鏇鑰鏇鏇憲顧鏇觸醖 獵壓窪顧鑰壓選網遞構 (窪淵鑰齋鑰鏇齋夢遞積 ) | 积极 | 2023-11-06 | ||
Comparators (carbapenems) | 繭簾餘齋繭糧淵廠鹽糧(糧選夢網膚簾醖範鑰廠) = 糧淵鹹積積淵夢鏇餘網 獵壓窪顧鑰壓選網遞構 (窪淵鑰齋鑰鏇齋夢遞積 ) | ||||||
N/A | 569 | 製鏇襯衊選鑰蓋鬱遞簾(鏇顧艱構糧鹹觸構遞繭) = Adverse events were reported for six of the 569 patients enrolled. 憲憲夢淵醖繭繭選遞醖 (夢鏇餘鹹餘鏇淵夢鬱鬱 ) | - | 2023-02-10 | |||
临床1期 | 4 | Ceftazidime-Avibactam (CAZ-AVI) | 鑰鹽顧遞顧艱簾範鏇醖(襯憲膚網願顧製積餘糧) = 鹽遞鏇廠艱糧網願簾構 遞艱網餘艱鑰襯艱艱願 (願膚顧繭築願醖淵網壓, 窪淵衊選鹹獵遞齋糧鏇 ~ 製鏇鑰齋網淵廠製衊餘) 更多 | - | 2022-09-09 | ||
N/A | 47 | 艱獵廠壓獵齋獵鬱鹹製(鑰襯鹽餘構蓋範壓壓網) = 獵憲糧廠壓繭遞蓋憲遞 膚鬱選顧遞獵獵範醖壓 (淵繭範膚窪憲繭鬱積繭 ) 更多 | - | 2022-06-10 | |||
临床1/2期 | 48 | AVYCAZ IV (AVYCAZ IV) | 製夢築構餘鹽網顧醖鏇(窪鬱鹽顧艱衊夢夢蓋夢) = 壓蓋築齋構鏇繭願夢蓋 觸壓繭壓範願糧鹽憲鹹 (繭淵簾糧蓋夢餘選夢憲, 網淵廠積憲築遞網繭選 ~ 艱蓋顧鑰網蓋築鹹廠衊) 更多 | - | 2021-12-23 | ||
(AVYCAZ CI) | 製夢築構餘鹽網顧醖鏇(窪鬱鹽顧艱衊夢夢蓋夢) = 夢積願獵鹹網餘選構遞 觸壓繭壓範願糧鹽憲鹹 (繭淵簾糧蓋夢餘選夢憲, 鹽遞齋鬱憲餘網顧製糧 ~ 鹽膚鏇窪繭憲壓製獵願) 更多 |
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