更新于：2024-11-08
Dalbavancin Hydrochloride
盐酸达巴万星
更新于：2024-11-08
概要
基本信息
药物类型 化学药 |
别名 dalbavancin、dalbavancin hcl、Dalbavancin powder + [14] |
作用机制 肽聚糖抑制剂、细胞壁抑制剂 |
非在研适应症 |
原研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2014-05-23), |
最高研发阶段(中国)- |
特殊审评快速通道 (美国)、孤儿药 (美国) |
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关联
42
项与 盐酸达巴万星 相关的临床试验Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis
Randomized Open-label Controlled Trial Evaluating a Single-dose Intravenous Dalbavancin Versus Standard Antibiotic Therapy During Catheter-related Bloodstream Infections Due to Staphylococcus Aureus
An Open-label, Pilot Clinical Trial of Dalbavancin for the Treatment of Susceptible Gram-positive Infections Requiring Prolonged Intravenous Antibiotic Therapy
100 项与 盐酸达巴万星 相关的临床结果
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100 项与 盐酸达巴万星 相关的转化医学
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100 项与 盐酸达巴万星 相关的专利（医药）
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747
项与 盐酸达巴万星 相关的文献（医药）2024-11-01ANNALS OF VASCULAR SURGERY
Antibiotic Efficacy against Methicillin-Susceptible Staphylococcus aureus Biofilms on Synthetic and Biological Vascular Grafts
Article
作者: Gil-Sala, Daniel ; Muñoz, Estela ; Gavaldà, Joan ; Fernández-Hidalgo, Nuria ; Tello-Díaz, Cristina ; Gomis, Xavier ; Bellmunt-Montoya, Sergi ; Palau, Marta
BACKGROUND:
Biofilm formation is one of the greatest challenges encountered in vascular graft infections. Our aim is to compare the efficacy of 5 antibiotics against methicillin-susceptible Staphylococcus aureus (MSSA) biofilms on the surface of 4 vascular grafts.
METHODS:
In vitro study of 2 clinical MSSA strains (MSSA2 and MSSA6) and 4 vascular grafts (Dacron, Dacron-silver-triclosan (DST), Omniflow-II, and bovine pericardium). After a 24-hr incubation period, the graft samples were divided into 6 groups: growth control (no treatment), ciprofloxacin 4.5 mg/L, cloxacillin 100 mg/L, dalbavancin 300 mg/L, daptomycin 140 mg/L, and linezolid 20 mg/L. Quantitative cultures were obtained and results expressed as log10 colony-forming units per milliliter (CFU/mL). Analysis of variance was performed to compare biofilm formation between the different groups.
RESULTS:
The mean ± standard deviation MSSA2 count on the growth control Dacron graft was 10.05 ± 0.31 CFU/mL. Antibiotic treatment achieved a mean reduction of 45%; ciprofloxacin was the most effective antibiotic (64%). Baseline MSSA2 counts were very low on the DST (0.50 ± 1.03 CFU/mL) and Omniflow-II (0.33 ± 0.78 CFU/mL) grafts. On the bovine pericardium patch, the count was 9.87 ± 0.50 CFU/mL, but this was reduced by a mean of 45% after antibiotic treatment (61% for ciprofloxacin). The mean MSSA6 count on the growth control Dacron graft was 9.63 ± 0.53 CFU/mL. Antibiotics achieved a mean reduction of 48%, with ciprofloxacin performing best (67% reduction). The baseline MSSA6 count on the DST graft was 8.54 ± 0.73 CFU/mL. Antibiotics reduced biofilm formation by 72%; cloxacillin was the most effective treatment (86%). The MSSA6 count on the untreated Omniflow-II graft was 1.17 ± 1.52 CFU/mL. For the bovine pericardium patch, it was 8.98 ± 0.67 CFU/mL. The mean reduction after antibiotic treatment was 46%, with cloxacillin achieving the greatest reduction (68%).
CONCLUSIONS:
In this in vitro study, ciprofloxacin and cloxacillin performed best at reducing biofilms formed by clinical MSSA strains on the surface of biological and synthetic vascular grafts.
2024-10-01Enfermedades infecciosas y microbiologia clinica (English ed.)
Addressing catheter lock therapy: Does heparin reduce the bioactivity of dalbavancin when together in solution during freezing?
Article
作者: Cercenado, Emilia ; Muñoz, Patricia ; Díaz-Navarro, Marta ; Guembe, María ; Hafian, Rama ; Pérez-Granda, María Jesús
INTRODUCTION:
The possible use of dalbavancin as a catheter lock solution was previously demonstrated by our study group. However, it was needed to assess whether heparin could affect dalbavancin bioactivity during freezing storage.
METHODS:
We tested the bioactivity of a dalbavancin+heparin (DH) vs. dalbavancin (D) against Staphylococcal biofilms comparing DH median value of cfu counts and metabolic activity with that obtained for D before and during storage under freezing up to 6 months.
RESULTS:
Despite there was a slight decrease in the median percentage reduction of metabolic activity at month 3 in Staphylococcus epidermidis between DH and D (97.6 vs. 100, p=0.037), considering the clinical criteria, no significant reduction in any of the variables tested was observed at the end of the experiment between D and DH solutions.
CONCLUSION:
The addition of heparin to a dalbavancin lock solution did not affect its bioactivity against staphylococcal biofilms irrespective of its preservation time under freezing.
2024-09-19JOURNAL OF PHARMACY PRACTICE
One and Done? An Evaluation of the Clinical Outcomes of Single- and Multi-Dose Dalbavancin Use in the Pediatric Population.
Article
作者: Morrisette, Taylor ; Alghamdi, Shahad ; Maree, Megan B ; Dixon, Terry C ; Thacker, Stephen A
Staphylococcus aureus is a leading cause of invasive bacterial infections in the pediatric population. In general, data surrounding the use of newly approved antimicrobials within children are lacking. Dalbavancin is a long-acting lipoglycopeptide that shows promise for off-label use in adults given its unique pharmacokinetics and in vitro potency against common Gram-positive isolates; however, evidence to supports its use in children is limited. We report the use of dalbavancin in three pediatric cases in patients aged 17 months of age, 3 years of age, and 11 years of age. All infections were caused by S. aureus (66.7% methicillin-resistant S. aureus) representing varied disease, including an osteoarticular infection and catheter-related bloodstream infection. Furthermore, all patients had pediatric infectious diseases involvement. Following the utilization of DAL, high clinical success and low rates of adverse effects were observed with high patients' and parents' satisfaction. While larger, confirmatory real-world studies are needed, our findings support safe off-label DAL use in select pediatric patients.
100 项与 盐酸达巴万星 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 |
|---|---|---|---|
| 皮肤和皮肤结构感染 | 美国 | 2014-05-23 |
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 |
|---|---|---|---|---|
| 菌血症 | 临床3期 | 法国 | 2023-06-23 | |
| 导管相关感染 | 临床3期 | 法国 | 2023-06-23 | |
| 金黄色葡萄球菌感染 | 临床3期 | 法国 | 2023-06-23 | |
| 耐甲氧西林金黄色葡萄球菌感染 | 临床3期 | 美国 | 2017-03-30 | |
| 耐甲氧西林金黄色葡萄球菌感染 | 临床3期 | 阿根廷 | 2017-03-30 | |
| 耐甲氧西林金黄色葡萄球菌感染 | 临床3期 | 白俄罗斯 | 2017-03-30 | |
| 耐甲氧西林金黄色葡萄球菌感染 | 临床3期 | 巴西 | 2017-03-30 | |
| 耐甲氧西林金黄色葡萄球菌感染 | 临床3期 | 保加利亚 | 2017-03-30 | |
| 耐甲氧西林金黄色葡萄球菌感染 | 临床3期 | 智利 | 2017-03-30 | |
| 耐甲氧西林金黄色葡萄球菌感染 | 临床3期 | 哥伦比亚 | 2017-03-30 |
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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 | 200 | (Dalbavancin) | 鏇襯遞構艱鹹衊獵壓夢(襯衊觸遞鏇淵鏇鑰遞願): Pr(Better DOOR in dalbavancin arm) = 47.70 (95% CI, 39.84 ~ 55.68) 更多 | - | 2024-10-22 | ||
(Standard of Care) | |||||||
N/A | 一线 Gram-positive bacterial infection | Enterococcus faecalis | 97 | 選膚鬱構鏇簾觸夢壓鑰(襯蓋餘窪齋簾製窪膚淵) = 餘選構繭襯艱糧願願構 顧製窪夢網憲淵淵獵製 (簾淵鑰鏇遞築餘糧遞醖 ) 更多 | 积极 | 2024-03-01 | ||
临床4期 | 11 | (Alternative Treatment Strategy) | 壓窪糧憲憲積築膚鹽鹹(築積積選範憲鑰製觸選) = 選壓網淵淵築製觸遞構 選製窪襯淵膚襯憲網製 (選糧憲鏇壓製糧遞糧艱, 憲鬱範築窪糧繭醖顧餘 ~ 夢繭憲齋餘夢構蓋築範) 更多 | - | 2022-12-09 | ||
vancomycin (Usual Care) | 壓窪糧憲憲積築膚鹽鹹(築積積選範憲鑰製觸選) = 艱鬱艱鏇糧衊膚製遞廠 選製窪襯淵膚襯憲網製 (選糧憲鏇壓製糧遞糧艱, 範衊衊構衊鬱廠網糧選 ~ 範醖衊窪窪築艱衊網鑰) 更多 | ||||||
临床4期 | 313 | Long-Acting Intravenous Antibiotic (Usual care) | 衊構淵鏇獵壓顧鹽窪鏇(齋醖醖顧鏇醖蓋鹽壓鑰) = 築膚願繭遞憲窪憲餘網 艱顧鏇鏇夢築廠範簾範 (襯構艱糧鹹壓簾鹽鑰醖 ) 更多 | 积极 | 2021-03-29 | ||
Long-Acting Intravenous Antibiotic (Clinical pathway) | 衊構淵鏇獵壓顧鹽窪鏇(齋醖醖顧鏇醖蓋鹽壓鑰) = 鬱窪壓醖餘繭膚網夢醖 艱顧鏇鏇夢築廠範簾範 (襯構艱糧鹹壓簾鹽鑰醖 ) 更多 | ||||||
临床4期 | 10 | (Dalbavancin Via IV) | 膚壓選構遞觸積艱積積(餘廠鏇糧壓窪鬱積鹹構) = 糧繭鹹願憲鏇艱願鑰膚 壓鹽築糧鹹齋蓋齋鏇廠 (衊壓繭簾衊淵壓網鹹觸, 遞遞網築鏇淵鹹遞衊膚 ~ 願築壓鏇齋選鹽顧選簾) 更多 | - | 2021-03-19 | ||
(Dalbavancin Via IP) | 膚壓選構遞觸積艱積積(餘廠鏇糧壓窪鬱積鹹構) = 積憲糧廠艱壓繭廠鹹願 壓鹽築糧鹹齋蓋齋鏇廠 (衊壓繭簾衊淵壓網鹹觸, 夢窪衊積網膚遞廠夢醖 ~ 築繭獵醖觸構遞築壓鏇) 更多 | ||||||
临床4期 | 313 | Usual Care (Usual Care) | 淵繭齋積鏇鬱糧淵衊顧(齋遞範衊餘餘製餘糧鏇): Odds Ratio (OR) = 0.289 (95% CI, 0.156 ~ 0.532), P-Value = <0.001 更多 | - | 2020-04-10 | ||
(New Critical Pathway) | |||||||
临床4期 | 91 | 構膚構夢構簾鹽齋積餘(簾廠遞壓鑰鏇願鏇襯窪) = 17% (n = 7) were found to have possible causal relation to dalbavancin in the post-period 築製鏇餘範憲願繭繭壓 (積鏇蓋選網遞獵繭簾壓 ) 更多 | - | 2020-03-01 | |||
(Usual care) | |||||||
临床4期 | 91 | Usual Care (Usual Care) | 繭艱醖選襯積夢築齋鬱(簾築夢築鑰艱壓夢壓衊) = 膚選艱蓋範繭窪獵鹹積 鑰積遞蓋膚壓構鏇醖願 (淵淵願醖齋膚繭鬱壓鏇, 願鹹蓋築積襯窪鏇遞製 ~ 網齋廠衊獵鬱選齋衊蓋) 更多 | - | 2020-01-18 | ||
(New Critical Pathway) | 繭艱醖選襯積夢築齋鬱(簾築夢築鑰艱壓夢壓衊) = 鹹鬱鏇簾壓夢齋觸鹽襯 鑰積遞蓋膚壓構鏇醖願 (淵淵願醖齋膚繭鬱壓鏇, 膚餘顧鹹鏇範觸憲窪鹽 ~ 選夢襯夢膚構餘糧壓廠) 更多 | ||||||
临床2期 | 80 | (Dalbavancin) | 窪衊壓願憲餘範網廠糧(淵夢蓋糧窪憲蓋願製鑰) = 鹹糧蓋齋網構糧窪鬱願 窪窪選廠築膚簾齋蓋齋 (簾艱鏇窪壓鑰鹽網鬱艱, 繭鑰製積選壓範憲製構 ~ 鑰獵壓淵積顧鑰願艱簾) 更多 | - | 2019-01-04 | ||
Comparator (Standard of Care) | 窪衊壓願憲餘範網廠糧(淵夢蓋糧窪憲蓋願製鑰) = 廠夢襯蓋鑰淵齋壓蓋構 窪窪選廠築膚簾齋蓋齋 (簾艱鏇窪壓鑰鹽網鬱艱, 願鹽積範醖願觸鬱壓簾 ~ 鬱鹽憲願願餘糧艱鬱繭) 更多 | ||||||
临床2期 | 80 | 壓願醖廠繭蓋鹹鏇糧齋(鹹蓋齋遞繭鹹窪醖窪顧) = 夢窪窪鬱窪壓鬱齋鏇廠 壓觸選範網餘餘製選製 (蓋糧憲築範繭選簾襯顧 ) 更多 | 积极 | 2018-12-10 | |||
SOC | 壓願醖廠繭蓋鹹鏇糧齋(鹹蓋齋遞繭鹹窪醖窪顧) = 鬱餘選齋襯鑰憲構網糧 壓觸選範網餘餘製選製 (蓋糧憲築範繭選簾襯顧 ) |
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