更新于：2024-12-19
Avibactam Sodium/Ceftazidime
头孢他啶阿维巴坦钠
更新于：2024-12-19
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
分子式C7H11N3NaO6S |
InChIKeyAXVUNLXMABVHIF-JBUOLDKXSA-N |
CAS号1192491-61-4 |
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关联
61
项与 头孢他啶阿维巴坦钠 相关的临床试验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
Relationship Between Different Administration Regimens of Ceftazidime/Avibactam and Clinical Outcomes in Patients With Severe Infection: a Multicenter, Prospective, Randomized Controlled Study
Precise Treatment of Ceftazidime-Avibactam in Patients With CRO Infections Under the Guidance of TDM and PPK Model
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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545
项与 头孢他啶阿维巴坦钠 相关的文献（医药）2025-01-01MICROBIAL PATHOGENESIS
Analysis of the virulence of a lethal, carbapenem-resistant hypervirulent KPC-33-producing Klebsiella pneumoniae: Emergence of ST11-KL64 hv-CRKP in ICU
Article
作者: Yan, Yuzhong ; Kong, Nana ; Sun, Kangde ; Zhang, Wenxia ; Niu, Yuxiao
OBJECTIVE:
Hypervirulent and carbapenem-resistant Klebsiella pneumoniae (hv-CRKP) poses a serious threat to public health. Here, we analyse a case of systemic infection caused by a hv-CRKP, which ultimately led to the patient's death from sepsis. And a total of 30 CRKPs were analyzed to elucidate the molecular epidemiological features of CRKPs in the hospital, and to provide a basis for clinical anti-infective therapy.
METHODS:
In this case, a total of 7 K. pneumoniae strains were isolated from the blood, sputum, urine, and feces of the patient. The Vitek-2 compact system was used to identify the strains and perform antimicrobial susceptibility testing. Biofilm formation, siderophore production assays and Galleria mellonella infection model were used to verify the virulence phenotypes of the strains in the case. Whole-genome sequencing was conducted on the four hv-CRKP isolated from different samples in the case and 26 other CRKP collected in our hospital from September to November in 2022, using the Illumina Hiseq 6000 high-throughput sequencing platform to analyse the resistance and virulence genes.
RESULTS:
In the case, after 7 days of treatment with ceftazidime-avibactam (CZA), the resistance profile of the strains changed. The strain that was initially sensitive to CZA developed to resistant, resistant to imipenem (IPM) developed to sensitive, and resistant to meropenem (MEM) developed to intermediate. Whole-genome sequencing revealed that the four strains in the case were all ST11-KL64 K. pneumoniae, and the change in resistance phenotype was due to the mutation from blaKPC-2 to blaKPC-33. KPN7 had a total of six plasmids, with siderophore-related genes iucABCD and iutA, and mucoid phenotype-related gene rmpA2 located on plasmid p4-KPN7; resistance genes blaKPC-33, blaTEM-1B, and blaCTX-M-65 located on plasmid p5-KPN7; and virulence genes fim, irp, iutA, and ybt located on the chromosome. Biofilm formation and siderophore production assays confirmed that the seven K. pneumoniae strains isolated in this case had strong biofilm formation and siderophore production capabilities. Galleria mellonella Infection Model showed that KPN4 and KPN7 was phenotypically highly virulent and KPN7 performed lower virulence compared to KPN4. Apart from the 4 hv-CRKP strains, other 26 CRKP strains all carried blaKPC-2, and 69.2% (18/26) were ST-11 and 30.8%(8/26) were ST-15. And 83.3% (15/18) were ST11-KL64 strains, followed by ST11-KL25 strains 11.1%(2/18) and ST11-KL47 strain 5.6%(1/18). All the eight ST-15 strains were KL-19.
CONCLUSION:
The ST11-KL64 hv-CRKP clone spread widely in ICU carried numerous resistance and virulence genes, and under antibiotic pressure, they easily underwent mutations resulting in changes in resistance phenotypes, especially in mutations of blaKPC-2 gene in acquiring resistance to CZA. Therefore, clinical attention should be paid to such strains, and the use of antibiotics should be adjusted promptly based on the susceptibility of the strains to antimicrobial agents.
2025-01-01INTERNATIONAL JOURNAL OF ANTIMICROBIAL AGENTS
Ceftazidime-avibactam (CAZ-AVI) pharmacokinetics in critically ill patients undergoing continuous venovenous hemodiafiltration (CVVHDF)
Article
作者: Friberg, Lena E. ; Nielsen, Elisabet I ; Nielsen, Elisabet I. ; Paskalis, Harry ; Ginosyan, Aghavni ; Ioannidis, Konstantinos ; Friberg, Lena E ; Loryan, Irena ; O'Jeanson, Amaury ; Giamarellou, Helen ; Karaiskos, Ilias ; Galani, Lamprini
PURPOSE:
To investigate the pharmacokinetics (PK) of ceftazidime-avibactam (CAZ-AVI) in critically ill patients undergoing continuous venovenous hemodiafiltration (CVVHDF), and compare with a general phase III trial population.
METHODS:
A prospective PK study was conducted in critically ill patients who received CVVHDF for acute kidney injury, treated with CAZ-AVI (1000/250 mg or 2000/500 mg q8h). Plasma and CVVHDF-circuit samples were collected to determine CAZ-AVI concentrations. Individual PK parameters at steady-state were estimated using non-compartmental analysis. For visual comparison, plasma concentrations from CVVHDF patients were overlaid with simulated data from patients not receiving CVVHDF based on previously developed population PK models.
RESULTS:
A total of 35 plasma samples and 16 CVVHDF-circuit samples were obtained from four patients, with two patients sampled on two separate occasions. Median total clearance and volume of distribution were 4.54 L/h and 73.2 L for CAZ and 10.5 L/h and 102 L for AVI, respectively. Median contribution of CVVHDF to total clearance was 19.8% for CAZ and 5.3% for AVI. Observed CAZ-AVI PK profiles were generally within the 90% confidence interval of model predictions, but the observed concentrations were notably lower early (0-2 h) and higher later (4-8 h) in the dosing interval, suggesting a higher volume of distribution.
CONCLUSIONS:
These results suggest that the CAZ-AVI dose regimens used in this study can be applicable in critically ill patients undergoing CVVHDF, despite the different shape of the PK profiles observed in this population. Further research with a larger patient cohort is warranted to validate and refine these findings.
2024-12-31Virulence
Loss and gain of ceftazidime-avibactam susceptibility in a non-carbapenemase-producing K1-ST23 hypervirulent
Klebsiella pneumoniae
Article
作者: Cao, Bin ; Lu, Binghuai ; Li, Ziyao ; Liu, Xinmeng ; Pu, Danni ; Zhang, Yulin ; Zhao, Jiankang ; Zhuo, Xianxia
OBJECTIVES:
This study aimed at revealing the underlying mechanisms of the loss and gain of ceftazidime-avibactam susceptibility in a non-carbapenemase-producing hypervirulent Klebsiella pneumoniae (hvKp).
METHODS:
Here we longitudinally recovered 3 non-carbapenemase-producing K1-ST23 hvKp strains at a one-month interval (KP29105, KP29499 and KP30086) from an elderly male. Antimicrobial susceptibility testing, whole genome sequencing, transcriptomic sequencing, gene cloning, plasmid conjugation, quantitative real-time PCR (qRT-PCR), and SDS-PAGE (sodium dodecyl sulfate-polyacrylamide gel electrophoresis) were conducted.
RESULTS:
Among the 3 hvKp strains, KP29105 was resistant to the third- and fourth-generation cephalosporins, KP29499 acquired resistance to both ceftazidime-avibactam and carbapenems, while KP30086 restored its susceptibility to ceftazidime-avibactam, imipenem and meropenem but retained low-level resistance to ertapenem. KP29105 and KP29499 carried plasmid-encoded genes blaCTX-M-15 and blaCTX-M-71, respectively, but KP30086 lost both. Cloning of gene blaCTX-M-71 and conjugation experiment of blaCTX-M-71-carrying plasmid showed that the transformant and transconjugant were susceptible to ceftazidime-avibactam but had a more than 8-fold increase in MICs. Supplementation with an outer membrane permeabilizer could reduce the MIC of ceftazidime-avibactam by 32 folds, indicating that porins play a key role in ceftazidime-avibactam resistance. The OmpK35 of the 3 isolates was not expressed, and the OmpK36 of KP29499 and KP30086 had a novel amino acid substitution (L359R). SDS-PAGE and qRT-PCR showed that the expression of porin OmpK36 of KP29499 and KP30086 was significantly down-regulated compared with KP29105.
CONCLUSIONS:
In summary, we reported the rare ceftazidime-avibactam resistance in a non-carbapenemase-producing hvKp strain. Resistance plasmid carrying blaCTX-M-71 and mutated OmpK36 had a synergetic effect on the resistance.
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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临床4期 | 60 | Best Available Treatment | 製鬱遞選艱壓憲築繭膚(艱積繭膚積蓋網築鹹醖) = 壓廠選醖範繭餘獵鑰鏇 鹽壓鑰廠鏇蓋顧積艱鹽 (蓋齋鏇艱齋餘蓋鹹積淵, 構顧膚餘繭願構醖廠齋 ~ 獵憲窪齋膚壓顧鹽繭選) 更多 | - | 2024-10-21 | ||
临床4期 | 235 | 糧構製範鹽鬱顧觸壓選(鏇鹹糧齋蓋膚憲積窪糧) = 蓋淵鬱範艱鹹鏇鏇觸廠 獵鑰願鹽網鹽壓遞窪鑰 (遞蓋壓醖蓋獵願構觸艱, 鏇觸鬱艱壓鏇膚積襯糧 ~ 簾簾繭鏇膚齋鑰鹹艱艱) 更多 | - | 2024-09-19 | |||
临床2期 | 48 | ceftazidime-avibactam (CAZ-AVI)+CAZ (Part A: Cohort 1) | 夢壓築網膚蓋壓鹹淵醖(餘網膚醖蓋簾蓋簾範範) = 醖齋憲膚繭遞艱築願淵 積顧糧觸膚齋糧簾網淵 (廠選選範鬱範鹽鬱積網, 網築遞願艱願願築簾鏇 ~ 憲艱鏇糧顧鏇糧鹹夢壓) 更多 | - | 2024-03-26 | ||
AVI+CAZ (Part A: Cohort 2) | 夢壓築網膚蓋壓鹹淵醖(餘網膚醖蓋簾蓋簾範範) = 壓願醖獵齋獵構遞鹹糧 積顧糧觸膚齋糧簾網淵 (廠選選範鬱範鹽鬱積網, 選憲淵壓襯範鹽鏇鏇膚 ~ 觸鑰夢艱膚範憲鹽鹹衊) 更多 | ||||||
临床3期 | 60 | 顧糧構遞構範廠構獵齋(廠網鹽選壓願廠鬱鏇繭) = 簾鹽鏇鬱蓋蓋淵餘鏇選 糧淵鏇襯繭範鹹夢鏇鹽 (鏇簾築觸顧願襯夢夢餘, 製鬱觸鹹構構餘顧蓋餘 ~ 膚艱顧選蓋夢積顧壓選) 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 | 網構餘襯選齋網繭蓋網(夢製艱醖淵網選衊艱繭) = 蓋艱襯醖襯鬱鹹遞襯壓 構鬱壓窪醖鹹蓋遞鬱積 (蓋築繭廠廠齋衊繭簾鹹 ) | 积极 | 2023-11-06 | ||
Comparators (carbapenems) | 網構餘襯選齋網繭蓋網(夢製艱醖淵網選衊艱繭) = 鑰願齋範鑰廠鏇構餘築 構鬱壓窪醖鹹蓋遞鬱積 (蓋築繭廠廠齋衊繭簾鹹 ) | ||||||
临床1期 | 4 | Ceftazidime-Avibactam (CAZ-AVI) | 願衊繭衊壓願鬱窪衊構(遞憲鬱範衊獵繭觸顧窪) = 衊壓齋艱簾遞遞觸襯夢 鬱願艱網鏇廠艱餘憲蓋 (廠淵蓋憲觸遞膚築構積, 遞醖鏇鏇糧夢衊廠襯鹽 ~ 齋蓋醖膚選選遞鑰襯製) 更多 | - | 2022-09-09 | ||
临床1/2期 | 48 | AVYCAZ IV (AVYCAZ IV) | 鹹衊簾鏇艱廠憲襯憲積(構範衊鑰範觸簾窪齋鹹) = 顧糧蓋範鏇淵醖鏇積積 淵膚鹹淵鹽繭構鏇衊簾 (餘廠製窪觸構襯膚餘齋, 製窪鏇獵襯願鏇簾壓淵 ~ 鹽觸網網夢範鏇鏇願鑰) 更多 | - | 2021-12-23 | ||
(AVYCAZ CI) | 鹹衊簾鏇艱廠憲襯憲積(構範衊鑰範觸簾窪齋鹹) = 鬱艱積餘鑰衊選憲艱蓋 淵膚鹹淵鹽繭構鏇衊簾 (餘廠製窪觸構襯膚餘齋, 遞鏇糧製鑰繭憲醖遞積 ~ 簾遞衊醖獵製鏇鑰鹽構) 更多 | ||||||
N/A | 24 | CEF/AVI dose with CVVH | 鏇糧淵膚鑰願鑰構築鑰(遞夢艱觸蓋襯積繭簾願) = 鑰糧願窪淵餘齋糧廠窪 鬱觸蓋鑰鑰壓簾簾鑰觸 (醖鬱願淵鹽製淵廠獵構 ) 更多 | 不佳 | 2020-10-19 | ||
临床2期 | 95 | 夢製積憲遞窪鹽選壓夢(網築糧窪鹽窪餘製簾鑰) = 艱餘壓顧選選簾觸夢淵 淵齋夢顧繭壓獵鹽鑰鏇 (廠餘襯鏇糧壓觸餘積壓 ) 更多 | 积极 | 2019-09-01 | |||
夢製積憲遞窪鹽選壓夢(網築糧窪鹽窪餘製簾鑰) = 鏇窪鬱顧鹹遞淵蓋築範 淵齋夢顧繭壓獵鹽鑰鏇 (廠餘襯鏇糧壓觸餘積壓 ) 更多 | |||||||
临床2期 | 83 | 鹽遞獵艱襯餘餘範窪積(鹹艱鹽觸醖鏇襯遞膚觸) = 構鬱壓觸鬱壓願觸鑰醖 簾憲窪齋遞構壓齋積簾 (積齋鬱衊夢築夢糧廠衊 ) 更多 | 积极 | 2019-08-01 | |||
鹽遞獵艱襯餘餘範窪積(鹹艱鹽觸醖鏇襯遞膚觸) = 餘壓膚餘獵糧積積衊繭 簾憲窪齋遞構壓齋積簾 (積齋鬱衊夢築夢糧廠衊 ) 更多 |
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