德拉沙星(Delafloxacin meglumine) - 药物靶点：Bacterial DNA gyrase x Topoisomerase IV_在研适应症：社区获得性肺炎，社区获得性细菌性肺炎，皮肤和皮肤结构感染_专利_临床

概要

基本信息

药物类型

小分子化药

别名

delafloxacin、Delafloxacin meglumine (USAN)、Quofenix

+ [7]

靶点

Bacterial DNA gyrase x Topoisomerase IV

作用机制

细菌DNA旋转酶复合体抑制剂、拓扑异构酶 IV抑制剂

治疗领域

感染呼吸系统疾病皮肤和肌肉骨骼疾病

在研适应症

社区获得性肺炎社区获得性细菌性肺炎皮肤和皮肤结构感染

非在研适应症

复杂皮肤和皮肤结构感染淋病肝病+ [4]

原研机构

Wakunaga Pharmaceutical Co., Ltd.

在研机构

A. Menarini Industrie Farmaceutiche Riunite SRLMelinta Subsidiary Corp.

非在研机构

Melinta Therapeutics, Inc.

最高研发阶段批准上市

首次获批日期

美国 (2017-06-19),

社区获得性细菌性肺炎皮肤和皮肤结构感染

最高研发阶段(中国)-

特殊审评快速通道 (美国)

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结构/序列

分子式C25H29ClF3N5O9

InChIKeyAHJGUEMIZPMAMR-WZTVWXICSA-N

CAS号352458-37-8

关联

17

项与德拉沙星相关的临床试验

NCT06612255

/ Terminated临床1期

A Phase 1, Single Part, Partially Randomised, Open-Label Study to Evaluate the Relative Bioavailability of a Taste-Masked Delafloxacin Powder for Oral Suspension With Oral Delafloxacin Tablet Reference in Healthy Subjects

This study will compare the bioavailability of a novel powder for oral suspension formulation of delafloxacin, intended for treatment of community acquired bacterial pneumonia, to that of the licensed delafloxacin oral tablet in healthy adults.

开始日期2024-06-03

申办/合作机构

Melinta Therapeutics, Inc.

[+1]

NCT05977868

/ Enrolling by invitation临床4期IIT

Comparing Oral Versus Parenteral Antimicrobial Therapy (COPAT) Trial

This is an investigator initiated multisite pragmatic randomized controlled trial designed to demonstrate equivalent effectiveness with improved safety of early transition from intravenous (IV) antimicrobial therapy to complex outpatient oral antimicrobial therapy (COpAT) across various infectious diseases (endovascular, bone and joint, skin and soft tissue, pulmonary, gastrointestinal, and genitourinary infections).
All patients referred for outpatient parenteral antimicrobial therapy (OPAT) will be evaluated by the research team with respect to inclusion/exclusion criteria. If determined eligible for enrollment, patients will be approached by a study investigator who will present the COPAT Trial. Once informed consent is obtained, patients will be randomized 2:1 using computer software into experimental or control (standard of care) group, respectively: Experimental: COpAT only on hospital discharge; Control: Conventional OPAT, OPAT transitioned to COpAT later in outpatient setting, or long-acting parenteral lipoglycopeptides. Both groups will be followed by an ID physician on the research team with in-person or telemedicine ID Clinic standard of care visits at 2, 6, and 12 weeks after hospital discharge. At the 6-week ID Clinic follow-up, patients will be asked to complete a patient satisfaction survey. The following 2 primary outcomes will be assessed: cure at 3 months using clinical (resolution of infection) and laboratory parameters (improvement in inflammatory markers) and adverse events related to antimicrobial therapy/vascular access complication. The following 3 secondary outcomes will be assessed: overall readmission at 3 months, readmission related to initial infection or antimicrobial therapy/vascular access complication at 3 months, and patient satisfaction at 6 weeks. The experimental group is being compared to standard of care in current clinical practice.
As this is a pragmatic clinical trial, patients will not undergo additional invasive testing or procedures.

开始日期2023-08-04

申办/合作机构

West Virginia University

CTR20213149

/ Completed临床1期

国产注射用德拉沙星在健康受试者中的安全性、耐受性、药代动力学特征评价以及与原研药的药代动力学比较的I期临床研究

1、评价国产注射用德拉沙星在中国健康受试者中单剂和多剂静脉滴注给药后的安全性、耐受性及药代动力学特征； 2、评价国产注射用德拉沙星试验药与对照药（商品名：Baxdela®）单剂静脉滴注给药后的药代动力学相似性，并评价两制剂单剂给药在中国健康受试者中的安全性。

开始日期2022-02-20

申办/合作机构

扬子江药业集团有限公司

100 项与德拉沙星相关的临床结果

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100 项与德拉沙星相关的转化医学

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100 项与德拉沙星相关的专利（医药）

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216

项与德拉沙星相关的文献（医药）

2024-12-24·ACS Omega

Delafloxacin-Loaded Poly(d,l-lactide-co-glycolide) Nanoparticles for Topical Ocular Use: In Vitro Characterization and Antimicrobial Activity

Article

作者: Ali, Raisuddin ; Alshememry, Abdullah K. ; Alhudaithi, Sulaiman S. ; Aldaham, Abdulrazzaq A. ; Alshumaimeri, Nada A. ; Kalam, Mohd Abul ; Shahid, Mudassar ; BinHudhud, Ziyad A. ; Binkhathlan, Ziyad ; Almomen, Aliyah A.

Objective: We developed delafloxacin (Dela)-loaded PLGA nanoparticles (PNPs) for potential ocular application via a topical route to treat eye infections caused by Gram-positive and Gram-negative bacteria. Methodology: Dela-PNPs were formulated using the emulsification-solvent evaporation method and stabilized using poly(vinyl alcohol) (PVA). Size and morphology were characterized by using dynamic light scattering (DLS) and scanning electron microscopy (SEM). Drug loading and encapsulation efficiency were measured via HPLC. Differential scanning calorimetry (DSC) and Fourier-transform infrared spectroscopy (FTIR) assessed the physical state and drug-polymer interaction. The in vitro drug release was evaluated using the dialysis bag method in simulated tear fluid (STF, pH 7.4) with Tween 80 (0.5%). The antimicrobial efficacy was determined by a minimum inhibitory concentration (MIC) and zone of inhibition tests against various bacteria. Results: Optimally sized PNPs were produced (238.9 ± 10.2 nm) with a PDI of 0.258 ± 0.084 and a ζ-potential of 2.78 ± 0.34 mV. Using 40 mg of PLGA, 4 mg of Dela, and 1% PVA, drug encapsulation and loading were 84.6 ± 7.3 and 12.9 ± 1.7%, respectively. DSC indicated that Dela was entrapped in an amorphous state within the PNPs. FTIR spectra showed no drug-polymer interactions. The formulation showed 40.6 ± 4.2% drug release within 24 h and 84.4 ± 6.1% by 96 h. MIC tests showed high susceptibility of Streptococcus pneumoniae, Klebsiella pneumoniae, and Escherichia coli (∼0.31 μg/mL) compared to Staphylococcus aureus and MRSA-6538 (∼0.63 μg/mL) and Bacillus subtilis (2.5 μg/mL). Stability studies showed minimal changes in particle characteristics over 3- and 6-month storage at 25 and 37 °C. Conclusion: Dela-PNPs exhibit significant potential as a nanoformulation for ocular applications.

2024-12-11·mBio

Metabolites augment oxidative stress to sensitize antibiotic-tolerant Staphylococcus aureus to fluoroquinolones

Article

作者: Taylor, Andrew J. ; Batchelder, Jonathan I. ; Mok, Wendy W. K.

ABSTRACT:

If left unchecked, infections involving antibiotic-refractory bacteria are expected to cause millions of deaths per year in the coming decades. Beyond genetically resistant bacteria, persisters, which are genetically susceptible cells that survive antibiotic doses that kill the rest of the clonal population, can potentially contribute to treatment failure and infection relapse. Stationary-phase bacterial cultures are enriched with persisters, and it has been shown that stimulating these populations with exogenous nutrients can reduce persistence to different classes of antibiotics, including topoisomerase-targeting fluoroquinolones (FQs). In this study, we show that adding glucose and amino acids to nutrient-starved Staphylococcus aureus cultures enhanced their sensitivity to FQs, including delafloxacin (Dela)—a drug that was recently approved for treating staphylococcal infections. We found that while the added nutrients increased nucleic acid synthesis, this increase was not required to sensitize S. aureus to FQs. We further demonstrate that addition of these nutrients increases membrane potential and the ability to generate harmful reactive oxygen species (ROS) during FQ treatment. Chelating iron, scavenging hydroxyl radicals, and limiting oxygenation during FQ treatment and during recovery following FQ treatment rescued nutrient-stimulated S. aureus . In all, our data suggest that while nutrient stimulation increases the activity of FQ targets in stationary-phase S. aureus , the resulting generation of ROS, presumably made possible through metabolic upregulation, is the primary driver of increased sensitivity to these drugs.

IMPORTANCE:

Staphylococcus aureus causes many chronic and relapsing infections because of its ability to endure host immunity and antibiotic therapy. While several studies have focused on the nutrient requirements for the formation and maintenance of staphylococcal infections, the effects of the nutrient environment on bacterial responses to antibiotic treatment remain understudied. Here, we show that adding nutrients to starved S. aureus activates biosynthetic processes, including DNA synthesis, but it is the generation of harmful reactive oxidants that sensitizes S. aureus to DNA topoisomerase-targeting FQs. Our results suggest that the development of approaches aimed at perturbing metabolism and increasing oxidative stress can potentiate the bactericidal activity of FQs against antibiotic-tolerant S. aureus .

2024-12-01·DIAGNOSTIC MICROBIOLOGY AND INFECTIOUS DISEASE

Delafloxacin, an alternative treatment for levofloxacin-resistant staphylococci in osteoarticular infections: To use or not to use?

Article

作者: Charlet, Audrey ; Wallet, Frédéric ; Senneville, Éric ; Lemonnier, Fanny ; Duployez, Claire ; Loïez, Caroline ; Migaud, Henri

Susceptibility of delafloxacin on 199 osteoarticular levofloxacin-resistant staphylococci strains was reported in 49% and 1% using SSTI S. aureus breakpoint (0.25 mg/L) and general S. aureus breakpoint (0.016 mg/L) respectively. Fifty percents levofloxacin-resistant staphylococci showed resistance to delafloxacin using CA-SFM/EUCAST recommendations. Microbiological societies should define new breakpoints especially for CoNS.

45

项与德拉沙星相关的新闻（医药）

2024-12-31

·米内网

【重磅】奥赛康出手了！抢攻9亿品种首仿

精彩内容 2024年12月31日，CDE官网显示，奥赛康的4类仿制药马立巴韦片上市申请获得承办。马立巴韦片为抗病毒制剂，原研药2023年全球销售额达191亿日元。马立巴韦片属于苯并咪唑核苷类药物，是全球首个且目前唯一一个靶向并抑制UL97蛋白激酶及其天然底物的抗病毒制剂。它靶向抑制CMV UL97蛋白激酶，抑制病毒DNA的复制、衣壳化和核逃逸，从而清除CMV血症并控制相关症状。武田的马立巴韦片最早于2021年11月获FDA批准上市，用于治疗接受造血干细胞移植（HSCT）或实体器官移植（SOT）后成人或12岁以上儿童患者的难治性巨细胞病毒（CMV）感染；2023年12月19日在中国获批上市，2024年11月进入国家医保乙类目录。米内网数据显示，武田的马立巴韦片2022年全球销售额达105亿日元，2023年全球销售额飙升至191亿日元（9.62亿元人民币，按2023年平均汇率）。武田马立巴韦片全球销售情况（百万日元）来源：米内网跨国上市公司销售库目前，国内仅有2家企业桂林南药、奥赛康提交马立巴韦片的仿制注册申请，谁将率先拿下国内首仿，我们拭目以待！ 2024年至今，奥赛康已有6个品种马来酸奈拉替尼片、注射用福沙匹坦双葡甲胺、注射用硫酸艾沙康唑、枸橼酸托瑞米芬片、注射用右兰索拉唑、艾曲泊帕乙醇胺片获批上市；一款1类新药利厄替尼片、5款仿制药马来酸阿伐曲泊帕片、注射用德拉沙星、甲氨蝶呤注射液、米库氯铵注射液、马立巴韦片提交注册申请。资料来源：米内网数据库、CDE 本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

上市批准

2024-12-10

·米内网

扬子江开挂了！首仿品种涨逾100%，拿下15个重磅品种，17个品种备战第十批集采

精彩内容今年以来，扬子江药业产品管线进展不断：15个品种获批生产并视同过评，6个品种以新注册分类报产。目前公司有169个品种过评或视同过评（37个首家/独家），51个品种在国采中选，多个品种实现放量，17个品种备战第十批集采；在研管线中，23款新药处于申请临床及以上阶段，5款新药冲刺上市，30个仿制药以新注册分类申报在审。拿下15个品种！169个过评品种霸屏近日，扬子江药业申报的4类仿制药ω-3脂肪酸乙酯90软胶囊获批生产并视同过评，为国产第6家获批。这是一款血脂调节剂，近年来在中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端的销售额均以三位数的增速增长。米内网数据显示，今年以来，扬子江药业仿制药管线持续推进，有15个品种获批生产并视同过评，包括7个注射剂、4个口服常释剂型、1个吸入剂、1个滴眼剂、1个口崩片、1个散剂/颗粒剂。今年以来扬子江药业获批上市的品种来源：米内网中国申报进度（MED）数据库多个品种为国内首批上市，其中醋酸钠林格葡萄糖注射液、盐酸艾司氯胺酮注射液国产第2家获批，他氟前列素滴眼液国产第3家获批，依托咪酯中/长链脂肪乳注射液、钆布醇注射液、替吉奥胶囊国产第4家获批等。目前扬子江药业已有169个品种通过/视同通过一致性评价，涵盖13个治疗大类，集中在全身用抗感染药物（32个）、神经系统药物（22个）、消化系统及代谢药（21个）、抗肿瘤和免疫调节剂（20个）等。扬子江药业已过评的品种注：标*为首家或独家过评来源：米内网一致性评价进度数据库 169个品种中，有37个为首家或独家过评，其中氨氯地平贝那普利胶囊、盐酸奈康唑乳膏、瑞戈非尼片、舒更葡糖钠注射液、注射用磷酸特地唑胺、恩替卡韦口服溶液等为首仿+首家过评。米内网数据显示，扬子江药业的舒更葡糖钠注射液2024上半年在中国公立医疗机构终端的销售额超过1亿元，同比增长106.23%。超140亿市场！17个品种备战第十批集采凭借庞大的过评产品集群，扬子江药业在国家开展的八批九轮化药集采中收获满满，分别有2个、4个、7个、8个、10个、12个、2个、6个品种中选，合计51个品种（盐酸帕洛诺司琼注射液不同批次重复计算），为集采头部供应商之一。多个“光脚”品种借助集采中选而迅速抢占市场。如第四批集采品种丙泊酚中/长链脂肪乳注射液，扬子江药业在该品种的市场份额由2021年的3.49%持续提升至2024上半年的12.2%；第五批集采品种盐酸帕洛诺司琼注射液、紫杉醇注射液，公司在上述2个品种的市场份额分别由2021年的7.99%、17.17%提升至2024上半年的18.33%、26.26%；第七批集采品种盐酸鲁拉西酮片、二甲双胍维格列汀片、唑来膦酸注射液，公司在上述3个品种的市场份额分别由2022年的0.74%、1.17%、9.76%提升至2024上半年的14.94%、25.21%、14.52%等。近年来在中国公立医疗机构终端扬子江药业在部分集采中选品种的市场份额变化来源：米内网中国公立医疗机构药品终端竞争格局 12月12日，第十批集采即将在上海开标，62个品种将展开激烈的竞价。扬子江药业有17个过评品种符合申报资格，包括10个注射剂、6个口服常释剂型、1个散剂/颗粒剂。扬子江药业第十批集采品种注：销售额不分规格，低于1亿元用*代替；最高采购额以首年约定采购量*最高有效申报价计来源：上海阳光医药采购网、米内网综合数据库从销售额看，17个品种2023年在中国公立医疗机构终端的销售额合计超过140亿元，依帕司他口服常释剂型、西格列汀口服常释剂型、利格列汀口服常释剂型、艾司洛尔注射剂、注射用盐酸罗沙替丁醋酸酯、间苯三酚注射剂、复方聚乙二醇电解质口服散剂7个品种超10亿元，除了注射用盐酸罗沙替丁醋酸酯，其余6个品种在第十批集采的最高采购额（首年约定采购量*最高有效申报价）均超过2亿元。从2023年市场竞争格局看，除了舒更葡糖钠注射液、依帕司他口服常释剂型，扬子江药业在其余15个品种所占市场份额均小于1%，其中帕拉米韦注射液、左西孟旦注射液、氢溴酸伏硫西汀片、盐酸艾司洛尔氯化钠注射液、泊沙康唑注射液、注射用盐酸罗沙替丁醋酸酯、间苯三酚注射液等为2023年获批品种，复方聚乙二醇电解质散(Ⅲ)、泊沙康唑肠溶片、卡前列素氨丁三醇注射液等为2024年新获批品种。若公司能在上述品种中顺利中选，则有望借助集采快速抢占市场。 30个新品在路上！5款新药上市可期今年以来，扬子江药业有6个品种以新注册分类报产在审。除去已获批/主动撤回/不批准的品种，目前公司有30个品种以新注册分类申报且在审，集中在神经系统药物（5个）、消化系统及代谢药（5个）、心脑血管系统药物（3个）等治疗大类。扬子江药业以新注册分类申报且在审的品种来源：米内网中国申报进度（MED）数据库 10个品种暂无首仿（含剂型首仿）获批上市，注射用盐酸达巴万星、注射用德拉沙星、美洛昔康纳米晶注射液、甲磺酸沙芬酰胺片、雷诺嗪缓释片、富马酸卢帕他定口服溶液等品种由扬子江药业首家或独家以新分类申报。创新药方面，今年11月，瑞科生物公告称，拟依据特别授权向认购方扬子江药业发行不超过1.43亿股内资股，认购价格为5.59元/股，本次定增完成后，扬子江药业将成为瑞科生物的第一大股东。创立于2012年的瑞科生物是一家创新型疫苗公司，2022年登陆港交所，目前拥有10余款创新疫苗管线组合，覆盖宫颈癌、带状疱疹、呼吸道合胞病毒等重大疾病领域。除了加码疫苗研发赛道，扬子江药业近年来也在推进创新转型，以“自主研发+外部引进”的方式，推动中药、化学药和生物药“三药并举”。含引进的新药在内，目前公司有23款新药（20款1类新药）处于申请临床及以上阶段（不含已上市新药开展新适应症），涵盖肿瘤、神经系统、消化及代谢系统、心脑血管系统、呼吸系统等治疗领域。 5款新药上市可期，妥诺达非（PDE-5抑制剂）、非苏拉赞（新型PPI抑制剂）分别于2023年2月及6月提交NDA，YZJ-1139（食欲素受体OX1/OX2拮抗剂）、感冒双解颗粒、复方蓉术颗粒均处于III期临床。资料来源：米内网数据库等注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。数据统计截至12月9日，如有疏漏，欢迎指正！本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

一致性评价上市批准免疫疗法

2024-12-02

·Business Wire

Melinta Joins NHIA Future of Infusion Advisory Council

ALEXANDRIA, Va. & PARSIPPANY, N.J.--( BUSINESS WIRE )--The National Home Infusion Association (NHIA) and Melinta Therapeutics, LLC (Melinta), a commercial-stage company providing innovative therapies for acute and life-threatening illnesses, are pleased to announce the addition of Melinta to NHIA’s Future of Infusion Advisory Council (FIAC). FIAC is a strategic advisory group comprised of manufacturing and service companies that are intensely invested in the home and alternate site infusion industry. The group consistently works with the association staff and Board of Directors to address critical issues, challenges, and opportunities facing this growing segment of healthcare. For Melinta, membership in the FIAC provides the opportunity for critical collaboration with the association and other organizations serving patients requiring infusion therapies. This work helps to enhance continuity of care as patients transition out of the hospital. “We’re excited to join FIAC and collaborate with health care professionals on the patient experience both immediately and long-term,” said John Harlow, Chief Commercial Officer at Melinta. “Through our partnership with NHIA, we have built a stronger understanding of the home infusion marketplace and customer needs, helping us address the changing landscape in outpatient infusion. Together, we can make a real difference in patient care – today and tomorrow.” Melinta Therapeutics is a biopharmaceutical company dedicated to providing innovative therapies to people impacted by acute and life-threatening illnesses. We focus our expanding portfolio on therapeutic areas with unmet needs to make the greatest possible impact on patients. Through collaboration with health care providers, we ensure the patients who need our therapies receive them. “We look forward to building on our long-standing partnership with Melinta through their engagement in FIAC,” said Connie Sullivan, NHIA President and CEO. “By collaborating with industry leaders in this way, we can improve upon the ways we mutually serve the infusion community, which helps more patients lead healthy, independent lives.” About NHIA National Home Infusion Association (NHIA) is a trade association that represents companies accredited to provide medically necessary infusion therapies to patients with acute and chronic health conditions, as well as companies that manufacture and supply infusion related products and services. Infusion therapy involves patient-specific compounded medications, supplies, and a range of pharmacy, nursing, and other clinical services for delivering care to patients in the home or suite setting. About Melinta Melinta Therapeutics is a biopharmaceutical company dedicated to providing innovative therapies to people impacted by acute and life-threatening illnesses. We focus our expanding portfolio on serving patients with an unmet need because that’s how we make the most meaningful impact. At Melinta, we’re visionaries dedicated to innovation while staying grounded in what matters most: patients. Our portfolio currently includes seven commercial-stage products: BAXDELA ® (delafloxacin), KIMYRSA ® (oritavancin), MINOCIN ® (minocycline) for Injection, ORBACTIV ® (oritavancin), REZZAYO™ (rezafungin for injection), TOPROL-XL ® (metoprolol succinate) and VABOMERE ® (meropenem and vaborbactam). For more information about Melinta Therapeutics, our commitment to patients, and to learn about our portfolio of therapies, including their important safety information, visit Melinta.com .

高管变更上市批准

100 项与德拉沙星相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09331	德拉沙星	J01MA23	DB11943

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
社区获得性肺炎	欧盟	A. Menarini Industrie Farmaceutiche Riunite SRL	2019-12-16
社区获得性肺炎	冰岛	A. Menarini Industrie Farmaceutiche Riunite SRL	2019-12-16
社区获得性肺炎	列支敦士登	A. Menarini Industrie Farmaceutiche Riunite SRL	2019-12-16
社区获得性肺炎	挪威	A. Menarini Industrie Farmaceutiche Riunite SRL	2019-12-16
社区获得性细菌性肺炎	美国	Melinta Subsidiary Corp.	2017-06-19
皮肤和皮肤结构感染	美国	Melinta Subsidiary Corp.	2017-06-19

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
手术伤口感染	临床3期	意大利	A. Menarini Industrie Farmaceutiche Riunite SRL	2019-09-25
皮肤结构和软组织感染	临床3期	美国	Melinta Therapeutics, Inc.	2014-05-01
皮肤结构和软组织感染	临床3期	阿根廷	Melinta Therapeutics, Inc.	2014-05-01
皮肤结构和软组织感染	临床3期	巴西	Melinta Therapeutics, Inc.	2014-05-01
皮肤结构和软组织感染	临床3期	保加利亚	Melinta Therapeutics, Inc.	2014-05-01
皮肤结构和软组织感染	临床3期	智利	Melinta Therapeutics, Inc.	2014-05-01
皮肤结构和软组织感染	临床3期	爱沙尼亚	Melinta Therapeutics, Inc.	2014-05-01
皮肤结构和软组织感染	临床3期	格鲁吉亚	Melinta Therapeutics, Inc.	2014-05-01
皮肤结构和软组织感染	临床3期	匈牙利	Melinta Therapeutics, Inc.	2014-05-01
皮肤结构和软组织感染	临床3期	拉脱维亚	Melinta Therapeutics, Inc.	2014-05-01

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临床结果

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分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04042077 (DRESS, CTgov)	临床3期	手术伤口感染	268	Delafloxacin (Delafloxacin)	糧遞糧繭艱築廠獵簾窪(艱廠願醖齋蓋觸繭築淵) = 構衊齋齋窪築淵鏇築齋獵積夢膚顧鑰構範醖網 (鹹醖鹹衊築膚築壓壓遞, 範夢獵窪構觸鬱膚鬱築 ~ 簾製鬱範鹽築簾糧製繭) 更多	-	2021-10-29
				Tigecycline+Linezolid+piperacillin/tazobactam+Vancomycin (Best Available Therapy)	糧遞糧繭艱築廠獵簾窪(艱廠願醖齋蓋觸繭築淵) = 構淵製衊遞構鬱蓋觸鹹獵積夢膚顧鑰構範醖網 (鹹醖鹹衊築膚築壓壓遞, 鏇壓願製願鬱觸鑰範廠 ~ 選齋膚鬱鹹鑰築範選壓) 更多
NCT02679573 (DEFINE-CABP, CTgov)	临床3期	社区获得性细菌性肺炎	860	Delafloxacin (Delafloxacin)	簾網獵範選製鑰鏇醖膚(醖廠襯憲繭夢觸鏇膚衊) = 壓窪鏇範餘膚獵夢鹽構築衊襯鏇醖壓憲艱壓獵 (築糧艱餘選鏇窪餘獵鹽, 積憲膚遞選夢淵構構艱 ~ 顧繭繭築淵鬱願獵鏇簾) 更多	-	2020-02-27
				Moxifloxacin+Linezolid (Moxifloxacin/Linezolid)	簾網獵範選製鑰鏇醖膚(醖廠襯憲繭夢觸鏇膚衊) = 糧遞鹹簾選鏇衊蓋繭膚築衊襯鏇醖壓憲艱壓獵 (築糧艱餘選鏇窪餘獵鹽, 遞夢廠顧繭築製艱願淵 ~ 鏇構繭鑰觸網鹹鏇淵艱) 更多
NCT03534622 (DEFINE-CABP, Pubmed) 人工标引	临床3期	社区获得性细菌性肺炎	-	Delafloxacin	壓壓齋觸鏇憲築鏇艱鬱(積網餘簾鬱鏇觸遞鬱壓) = 齋獵鏇糧鹽衊範艱鬱範鏇膚顧顧構糧鏇夢範膚 (蓋廠壓廠齋鏇願簾製廠 ) 更多	非劣	2019-12-05
				Moxifloxacin	壓壓齋觸鏇憲築鏇艱鬱(積網餘簾鬱鏇觸遞鬱壓) = 觸齋糧蓋繭積鏇製壓鏇鏇膚顧顧構糧鏇夢範膚 (蓋廠壓廠齋鏇願簾製廠 ) 更多
NCT02015637 (Pubmed \| Sex Transm Dis) 人工标引	临床3期	淋病	328	Delafloxacin	壓衊簾艱糧窪繭廠膚廠(願齋觸鑰蓋壓糧網顧衊) = 衊糧膚積積壓齋壓繭製製願鑰遞鹽範醖鹹遞選 (簾窪襯窪鏇淵鹽壓襯範 )	非优	2019-05-01
				ceftriaxone	壓衊簾艱糧窪繭廠膚廠(願齋觸鑰蓋壓糧網顧衊) = 憲選艱顧鑰餘獵醖鏇壓製願鑰遞鹽範醖鹹遞選 (簾窪襯窪鏇淵鹽壓襯範 )
NCT01811732 \| NCT01984684 (Pubmed \| Open Forum Infect Dis)	临床3期	皮肤和皮肤结构感染	-	Delafloxacin	簾齋鬱獵艱顧願窪願繭(鑰襯廠膚構齋壓鹽網艱) = 繭夢齋襯齋範膚願積窪膚築願餘壓遞鬱遞選艱 (築選鏇網構範鏇糧製夢 )	-	2018-10-01
				Comparators	簾齋鬱獵艱顧願窪願繭(鑰襯廠膚構齋壓鹽網艱) = 觸襯顧鏇壓憲選鏇繭築膚築願餘壓遞鬱遞選艱 (築選鏇網構範鏇糧製夢 )
NCT01984684 (Pubmed) 人工标引	临床3期	皮肤和皮肤结构感染一线	850	Delafloxacin	憲遞糧積鑰艱憲顧選遞(範襯網鏇願夢構構鹽鹹) = 製築遞觸繭鑰糧淵衊憲膚艱網選網鬱艱衊鑰簾 (糧壓觸鏇艱膚鏇製廠醖 ) 更多	非劣	2018-08-16
				vancomycin+aztreonam	憲遞糧積鑰艱憲顧選遞(範襯網鏇願夢構構鹽鹹) = 夢鏇淵遞遞鏇繭膚繭網膚艱網選網鬱艱衊鑰簾 (糧壓觸鏇艱膚鏇製廠醖 ) 更多
NCT02015637 (CTgov)	临床3期	淋病	460	Delafloxacin (Delafloxacin)	繭繭築衊廠願襯獵構築(鹽齋壓膚鏇顧簾積願遞): Difference in cure rate = -5.9 (95% CI, -13.18 ~ 1.36) 更多	-	2018-04-26
				Ceftriaxone (Ceftriaxone)
NCT01811732 (Pubmed \| J Antimicrob Chemother) 人工标引	临床3期	皮肤和皮肤结构感染	660	delafloxacin	蓋繭憲鹽構鬱夢壓範製(衊夢襯餘憲衊艱衊築衊) = 膚選顧窪遞繭構積構艱構醖憲窪窪夢願製膚壓 (積窪壓繭齋製選壓觸鏇 ) 更多	非劣	2017-12-01
				vancomycin+aztreonam	蓋繭憲鹽構鬱夢壓範製(衊夢襯餘憲衊艱衊築衊) = 選鑰觸顧積觸淵膚壓選構醖憲窪窪夢願製膚壓 (積窪壓繭齋製選壓觸鏇 ) 更多
NCT01984684 (CTgov)	临床3期	皮肤结构和软组织感染 \| 细菌性皮肤疾病 \| 皮肤和皮肤结构感染	850	delafloxacin (Delafloxacin)	鬱繭簾遞網網願壓齋範(壓夢鬱憲網鹹糧鏇窪淵): Difference in Responder Rates = 3.1 (95% CI, -2.0 ~ 8.3) 更多	-	2017-08-28
				aztreonam+Vancomycin (Vancomycin Plus Aztreonam)
NCT01811732 (CTgov)	临床3期	细菌性皮肤疾病 \| 皮肤和皮肤结构感染	660	Placebo+Delafloxacin (Delafloxacin Plus Placebo)	遞積蓋憲醖鹹鑰積積觸(餘膚餘繭製簾繭鹽窪餘) = 繭蓋鬱夢衊壓餘鏇繭壓鹽願窪遞構願製艱觸艱 (壓製繭獵鹹糧鹹選繭網, 簾獵醖獵構膚顧夢積淵 ~ 廠鬱糧壓網願觸顧鏇構) 更多	-	2017-08-24
				Placebo+Aztreonam+Vancomycin (Vancomycin Plus Aztreonam + Placebo)	遞積蓋憲醖鹹鑰積積觸(餘膚餘繭製簾繭鹽窪餘) = 齋觸蓋壓築壓繭觸構構鹽願窪遞構願製艱觸艱 (壓製繭獵鹹糧鹹選繭網, 廠繭範艱壓淵衊壓夢壓 ~ 襯糧衊艱蓋齋鏇鹽齋鹽) 更多