预约演示
更新于：2025-03-23
Amoxicillin/Clavulanate Potassium
阿莫西林/克拉维酸钾
更新于：2025-03-23
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- |
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结构/序列
分子式C24H28KN4O10S |
InChIKeyVKJFJOFNYVFTRZ-ZVDZYBSKSA-N |
CAS号74469-00-4 |
关联
261
项与 阿莫西林/克拉维酸钾 相关的临床试验NCT06850714
Evaluation of the Use of Bifidobacterium Breve PRL2020 in Preventing Side Effects From Amoxicillin or Amoxicillin/Clavulanic Acid Antibiotic Use: A Randomized Controlled Trial
NCT06709196
REINFORCE - Reducing Infection-related Readmissions Following Cystectomy. a Multicentre Randomised Clinical Trial Testing Superiority of Individualised Targeted Antibiotic Prophylaxis Over Empiric Prophylaxis At Ureteral Stent Removal to Reduce Infection-related Readmissions Following Cystectomy.
NCT06502288
Evaluation of Necessity of Antibiotic Administration Following Tooth Extraction: A Randomized Control Trial
100 项与 阿莫西林/克拉维酸钾 相关的临床结果
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100 项与 阿莫西林/克拉维酸钾 相关的转化医学
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100 项与 阿莫西林/克拉维酸钾 相关的专利（医药）
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5,226
项与 阿莫西林/克拉维酸钾 相关的文献（医药）2025-03-04Microbiology Spectrum
The impact of aztreonam–clavulanic acid exposure on gene expression and mutant selection using a multidrug-resistant
E. coli
Article
作者: Lin, Tongtong ; Diao, Shuo ; Huang, Junyi ; Zhang, Kexin ; Lv, Zhihua ; Shen, Xiaopeng ; Sy, Sherwin K. B. ; Zhang, Jiayuan ; Lynch, Michael ; Wang, Yaohai ; Long, Hongan ; Cao, Jichao ; Yu, Mingming ; Yan, Jinke
ABSTRACT:
Multidrug-resistant
Escherichia coli
poses a significant threat to the healthcare system by causing treatment failure in infected patients. The use of a beta-lactam in combination with a beta-lactamase inhibitor has been shown to be an effective strategy to solve this problem.
In vitro
antimicrobial susceptibility experiments have demonstrated the antimicrobial activity of aztreonam and clavulanate. In this investigation, we conducted a transcriptomic analysis to reveal the downstream differential gene expression in
E. coli
ymmD45 (a strain newly isolated and found to carry the New Delhi metallo-β-lactamase gene) following exposure to aztreonam and clavulanate separately, as well as their combination. Differential gene expression, pathway enrichment, and gene network analyses demonstrated the polygenic nature of the response to the combination treatment, which suppressed the expression of pivotal virulence genes, disrupted two-component regulatory systems for bacteria to resist external stress, and interfered with the formation of the cellular membrane. Results from single-step mutant selection combined with deep whole-genome sequencing also revealed the spontaneous origin of the resistance mutations and confirmed action mechanisms during the combination treatment. Our study contributes valuable insights into the impact of antibiotic exposure on gene expression, laying the groundwork for understanding antibiotic resistance development in the treatment of multi-drug resistant infections through
in vitro
studies.
IMPORTANCE:
Multidrug-resistant
Escherichia coli
is a major challenge in treating infections effectively. Aztreonam and clavulanate combination is promising in combating these resistant bacteria. By investigating the antimicrobial activity of aztreonam and clavulanate using transcriptomic analysis and mutant selection, this research sheds light on the mechanisms underlying antibiotic resistance and the effectiveness of combination therapies. The findings highlight how this particular antibiotic combination suppresses virulence genes, disrupts bacterial regulatory systems, and interferes with cellular functions critical for resistance. Moreover, the study lays the groundwork for understanding antibiotic resistance development in the treatment of multi-drug resistant infections through
in vitro
studies, offering insights that could inform future strategies in clinical settings. Ultimately, our findings could guide the development of better treatment strategies for multidrug-resistant infections, improving patient outcomes and helping to manage antibiotic resistance in healthcare.
2025-03-01Zoonoses and Public Health
High Occurrence of ST131 Among Extraintestinal Pathogenic Escherichia coli in Humans and Dogs in Sri Lanka
Article
作者: Dissanayake, D. R. Anuruddhika ; Lan, Ruiting ; Dissanayake, B. G. Nilanthi ; Dewasmika, W. A. Pamudi Maldam ; Prasada, D. V. Pahan ; Octavia, Sophie ; Francis, Veithehi Rajeevan ; Neelawala, N. G. Dulanjalee Anuruddhika Kumari
ABSTRACT:
Aims:
Extraintestinal pathogenic Escherichia coli (ExPEC) is an important human and animal pathogen. In particular, the ST131 of ExPEC is a widely distributed clone, resistant to extended‐spectrum cephalosporins and fluoroquinolones. We investigated the occurrence of ST131 among ExPEC from humans and dogs in Sri Lanka and determined its antimicrobial resistance.
Methods:
A total of 215 ExPEC isolates were collected from humans (n = 179) and dogs (n = 36) from two different cities in Sri Lanka. Antimicrobial resistance was tested by the disk diffusion method, and the presence of resistance‐encoding genes (blaTEM, blaSHV and blaCTX‐M) and ST131 clades/subclades was tested by PCR.
Results:
The majority of the isolates were (61.8%) ST131, with 55.8% in ST131‐clade C. Of the clade C isolates, 44.3%, 27.8%, 15.7% and 6.7% were in clades C2, C other, C1‐non‐M27 and C1‐M27, respectively. Approximately 11% of the ST131 isolates were carbapenem resistant. ExPEC from dogs showed comparable resistance rates to human isolates except for resistance to amoxicillin‐clavulanate and amikacin.
Conclusion:
We observed a high occurrence of ST131 and its clade C, with more than 11% exhibiting resistance to carbapenems in Sri Lanka. Furthermore, ST131‐C1‐M27, with high resistance to both quinolones and extended‐spectrum cephalosporins, was also present. Our results emphasise the importance of the One Health approach in the monitoring of antimicrobial‐resistant E. coli in different regions of Sri Lanka to gain a better understanding of their prevalence over time, contributing to effective antimicrobial stewardship.
2025-03-01CLINICAL MICROBIOLOGY AND INFECTION
A phase 3 randomized trial of sulopenem vs. ertapenem in patients with complicated intra-abdominal infections
Article
作者: Zelasky, Michael T ; Breen, Jeanne D ; Akinapelli, Karthik ; Dunne, Michael W ; Das, Anita F ; Breen, Jeanne ; Aronin, Steven I ; Aronin, Steven I. ; Dunne, Michael W. ; Das, Anita F. ; Puttagunta, Sailaja ; Zelasky, Michael T.
OBJECTIVE:
To demonstrate the non-inferiority of intravenous (IV) sulopenem to IV ertapenem, each followed by an oral regimen, in adults with complicated intra-abdominal infections (cIAI).
METHODS:
Hospitalized adults with cIAI were randomly assigned to 5 days of IV sulopenem followed by oral sulopenem etzadroxil/probenecid twice daily or 5 days of IV ertapenem followed by oral ciprofloxacin/metronidazole or amoxicillin-clavulanate depending on baseline pathogen susceptibility. The target treatment duration was 7-10 days. The primary (FDA [Food and Drug Administration]-specified) endpoint was clinical response at day 28 (test-of-cure) in the micro-modified intent-to-treat (micro-MITT) population.
RESULTS:
A total of 674 patients were randomly assigned. The two treatment arms were well balanced. Escherichia coli (395 patients) and Bacteroides fragilis (111 patients) were the most frequently isolated pathogens. Clinical success rates in the micro-MITT population were 81.9% (204/249) for sulopenem-treated patients and 87.9% (233/265) for ertapenem-treated patients. The lower bound of the CI for the treatment difference of the primary endpoint was below the pre-specified non-inferiority margin of -10.0 (treatment difference -6.0%, 95% CI, [-12.2 to 0.2]). In all other analysis populations, the lower limit of the 95% CI was above -10.0. Treatment-emergent adverse events (all, 26.0% [87/335] vs. 23.4% [78/333]; related, 6.0% [20/335] vs. 5.1% [17/333]) were similar for sulopenem and ertapenem, respectively. Most events were mild to moderate in severity. There were more serious adverse events in the sulopenem arm (7.5% [25/335] vs. 3.6% [12/333]), only two of which were considered possibly drug-related.
DISCUSSION:
Sulopenem IV followed by oral sulopenem etzadroxil/probenecid was not non-inferior to ertapenem followed by oral step-down in treating cIAI in the micro-MITT population. This finding should be interpreted in the context of country regulations, as endpoint timing, primary analysis population and non-inferiority margin may vary regionally. Both IV and oral sulopenem were well-tolerated; the oral formulation allowed patients with resistant pathogens to step-down from IV therapy.
100 项与 阿莫西林/克拉维酸钾 相关的药物交易
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外链
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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 |
|---|---|---|---|
| 骨和关节感染 | 加拿大 | 2020-01-28 | |
| 妇科疾病 | 加拿大 | 2020-01-28 | |
| 腹腔感染 | 加拿大 | 2020-01-28 | |
| 严重感染 | 加拿大 | 2020-01-28 | |
| 皮肤结构和软组织感染 | 加拿大 | 2020-01-28 | |
| 急性细菌性鼻窦炎 | 美国 | 2002-09-25 | |
| 慢性支气管炎 | 澳大利亚 | 1998-01-08 | |
| 社区获得性肺炎 | 澳大利亚 | 1998-01-08 | |
| 急性支气管炎 | 日本 | 1988-08-01 | |
| 咽炎 | 日本 | 1988-08-01 | |
| 扁桃体炎 | 日本 | 1988-08-01 | |
| 膀胱炎 | 日本 | 1985-07-29 | |
| 淋病 | 日本 | 1985-07-29 | |
| 子宫内感染 | 日本 | 1985-07-29 | |
| 淋巴结炎 | 日本 | 1985-07-29 | |
| 简单的皮肤和皮肤结构感染(uSSSI) | 日本 | 1985-07-29 | |
| 肾盂肾炎 | 日本 | 1985-07-29 | |
| 脓皮症 | 日本 | 1985-07-29 | |
| 慢性呼吸道感染 | 日本 | 1985-07-29 | |
| 细菌感染 | 美国 | 1985-07-22 |
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 |
|---|---|---|---|---|
| 急性鼻窦炎 | 临床3期 | 日本 | 2013-08-30 | |
| 前极白内障 | 临床2期 | - | 2023-06-23 | |
| 急性肾盂肾炎 | 临床2期 | 中国 | 2023-02-10 | |
| 布路里溃疡 | 临床2期 | 贝宁 | 2021-12-01 | |
| 化脓 | 临床2期 | 中国 | 2015-05-19 | |
| 泌尿系统感染 | 临床2期 | 中国 | 2013-05-15 | |
| 化脓性扁桃体炎 | 临床2期 | 中国 | 2013-05-15 | |
| 急性中耳炎 | 临床1期 | 中国 | 2024-04-22 | |
| 蜂窝织炎 | 临床1期 | 中国 | 2024-04-22 | |
| 骨髓炎 | 临床1期 | 中国 | 2024-04-22 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床2期 | 3 | (Standard Perioperative Antibiotics) | 構衊艱蓋築蓋範壓築艱(簾壓膚網築窪齋鑰網鹹) = 獵夢憲繭遞壓鑰願淵構 築廠膚積齋糧蓋願餘築 (餘蓋艱鏇鑰艱齋願壓鬱, 夢憲餘廠襯積鏇窪淵網 ~ 衊鹽壓餘積蓋簾蓋繭鏇) 更多 | - | 2024-09-24 | ||
(Extended Antibiotic Prophylaxis) | 簾夢蓋繭構襯構蓋蓋醖 = 廠構廠製繭襯齋糧糧襯 鹽繭蓋衊窪醖獵蓋遞觸 (選糧壓艱餘範壓窪淵餘, 醖鑰鹹醖鬱願蓋選廠餘 ~ 鏇積夢觸廠鹹壓積糧遞) 更多 | ||||||
临床4期 | 23 | 築獵構遞衊築餘鏇鹹憲 = 窪膚製淵選網範窪鹹鏇 醖壓遞獵壓膚積夢鬱願 (廠鑰憲構餘顧餘獵顧衊, 夢構糧願糧顧鏇襯廠淵 ~ 網鹹鹹夢憲選願憲餘選) 更多 | - | 2024-08-14 | |||
临床4期 | 116 | 獵夢構窪襯獵積積艱膚 = 簾範餘鬱夢壓簾窪築獵 艱鬱鏇壓構鏇遞鬱夢壓 (鏇衊選顧鑰夢構醖鹹積, 糧餘網餘憲構製選餘衊 ~ 夢餘淵餘淵齋廠夢艱鏇) 更多 | - | 2024-05-16 | |||
临床4期 | 310 | (Participants With Acute Otitis Media (AOM) Receiving Augmentin (ES)-600) | 壓蓋淵衊衊築艱遞繭選 = 繭壓範獵衊壓製範壓觸 廠製醖觸簾鏇蓋醖淵醖 (鑰餘艱糧醖膚鏇鹹鹽鏇, 醖繭餘醖艱遞鬱餘膚醖 ~ 廠廠簾鬱獵廠鹹蓋夢糧) 更多 | - | 2024-04-25 | ||
(Participants With Acute Bacterial Rhinosinusitis (ABRS) Receiving Augmentin (ES)-600) | 壓蓋淵衊衊築艱遞繭選 = 築繭願艱顧憲衊製壓鏇 廠製醖觸簾鏇蓋醖淵醖 (鑰餘艱糧醖膚鏇鹹鹽鏇, 淵鬱壓壓鹹構艱窪繭鏇 ~ 觸憲鏇積顧顧糧糧鏇艱) 更多 | ||||||
临床2期 | 112 | (Rifampin Resistant A) | 齋鏇鏇構鏇獵衊觸選範(齋範窪構糧觸醖窪廠鏇) = 構醖餘範鏇積窪艱鏇鹽 餘鬱窪製衊衊窪範範廠 (構鑰夢窪選顧衊製衊鏇, 醖觸遞範襯鬱鏇繭繭鑰 ~ 觸製觸鑰廠糧觸淵膚鬱) 更多 | - | 2023-07-19 | ||
(Rifampin Resistant B) | 齋鏇鏇構鏇獵衊觸選範(齋範窪構糧觸醖窪廠鏇) = 築願艱網鬱簾製憲觸壓 餘鬱窪製衊衊窪範範廠 (構鑰夢窪選顧衊製衊鏇, 淵齋廠鑰壓淵積鏇廠鹽 ~ 憲簾艱膚鑰鹹選醖醖獵) 更多 | ||||||
临床3期 | 515 | (Amoxicillin-clavulanate) | 簾積齋構襯醖衊鑰糧膚(鑰齋齋淵壓觸積網壓夢) = 鏇鑰鏇選獵觸簾鏇糧製 積糧憲醖網齋齋選餘製 (觸範膚願鏇鹹艱衊顧膚, 7.8) 更多 | - | 2023-06-08 | ||
Placebo (Placebo) | 簾積齋構襯醖衊鑰糧膚(鑰齋齋淵壓觸積網壓夢) = 窪壓鏇壓醖鏇築廠夢願 積糧憲醖網齋齋選餘製 (觸範膚願鏇鹹艱衊顧膚, 7.6) 更多 | ||||||
临床2期 | 60 | (Pathological Phenotype) | 齋淵蓋壓壓繭構膚遞壓(積夢齋積構築選鑰獵構) = 簾糧糧鬱遞築蓋淵艱網 齋憲糧遞積齋壓遞鹹淵 (製淵蓋餘鏇網蓋製齋網, 襯蓋衊鏇觸廠範獵憲鬱 ~ 積艱憲製餘憲繭夢構願) 更多 | - | 2023-03-06 | ||
(Clinical Guidelines) | 齋淵蓋壓壓繭構膚遞壓(積夢齋積構築選鑰獵構) = 構製鏇選淵壓選夢夢構 齋憲糧遞積齋壓遞鹹淵 (製淵蓋餘鏇網蓋製齋網, 鬱獵繭糧構構願顧膚廠 ~ 艱齋淵窪觸壓淵淵鑰製) 更多 | ||||||
N/A | 82 | peripheral inserted central Catheter+home intravenous ertapenem (Home Intravenous Ertapenem and PICC) | 繭衊鏇遞艱夢願繭鬱鏇 = 壓觸鏇繭蓋淵鑰鬱齋鏇 壓構構觸繭鏇築衊簾醖 (願鬱糧憲築蓋獵蓋願鏇, 醖醖鏇憲網鹹膚憲壓製 ~ 壓壓範糧醖獵膚蓋鑰憲) 更多 | - | 2022-03-23 | ||
(Home Oral Amoxicillin-clavulanate) | 繭衊鏇遞艱夢願繭鬱鏇 = 觸艱衊齋鬱築蓋廠鹹觸 壓構構觸繭鏇築衊簾醖 (願鬱糧憲築蓋獵蓋願鏇, 製網艱膚獵艱齋膚糧膚 ~ 糧醖獵選鏇積簾築選艱) 更多 | ||||||
临床3期 | 284 | Prednisolone plus antibiotics | 鏇醖襯積繭淵觸醖築鏇(選鑰衊積艱壓鏇範淵觸) = 願襯窪網廠糧簾選糧鬱 蓋餘鏇構齋鹽製鬱鬱鏇 (範壓鬱糧膚襯齋鹽築艱 ) 更多 | 不佳 | 2021-06-23 | ||
Prednisolone plus placebo | 鏇醖襯積繭淵觸醖築鏇(選鑰衊積艱壓鏇範淵觸) = 網獵簾憲淵衊鏇醖襯簾 蓋餘鏇構齋鹽製鬱鬱鏇 (範壓鬱糧膚襯齋鹽築艱 ) 更多 | ||||||
临床4期 | 385 | (Short Course) | 顧願鏇鏇觸鹹窪鹹鹽築: Pr (Higher DOOR in Short-Course) = 0.69 (95% CI, 0.63 ~ 0.75), P-Value = <0.001 更多 | - | 2021-02-03 | ||
(Standard Course) |
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