Antibacterial Resistance Leadership Group (ARLG)

抗菌素耐药性领导小组 (ARLG)

• 批准号: 10247231
• 负责人: Vance G. Fowler
• 金额: $ 5.64万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-06-01 至 2026-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10247231
• 关键词: Address; Area; Award; Bacteria; Bacterial Drug Resistance; Bacterial Infections; Bacteriophages; Biometry; Childhood; Clinical; Clinical Research; Clinical Trials; Clinical Trials Network; Communities; Complement; Complex; Data Analyses; Development; Diagnostic; Diagnostic tests; Drug Industry; Drug resistant Pseudomonas aeruginosa; Ensure; Evaluation; Gene Expression; Goals; Gonorrhea; Gram-Negative Bacteria; Gram-Negative Bacterial Infections; Gram-Positive Bacterial Infections; Health; Human; Infrastructure; Interdisciplinary Study; International; Knowledge; Laboratories; Laboratory Research; Lead; Leadership; Mentors; Messenger RNA; Methodology; Molecular Epidemiology; Multi-Drug Resistance; Paper; Participant; Patients; Phenotype; Pneumonia; Positioning Attribute; Principal Investigator; Productivity; Program Sustainability; Protocols documentation; Publications; Publishing; Randomized Controlled Trials; Research; Research Activity; Research Design; Research Infrastructure; Research Institute; Research Personnel; Resources; Respiratory Tract Infections; Robin bird; Sepsis; Services; Site; Technology; Testing; Therapeutic; Therapeutic Clinical Trial; Therapeutic Monoclonal Antibodies; Training; Training Support; United States Food and Drug Administration; Viral; World Health Organization; bacterial resistance; base; biobank; clinical diagnostics; clinical epidemiology; combat; data management; design; experience; fundamental research; improved outcome; innovation; member; methicillin resistant Staphylococcus aureus; multi-drug resistant pathogen; next generation; novel diagnostics; operation; organizational structure; pathogen; programs; protocol development; scaffold; statistics; success; virtual

Our goal is to continue to advance the successful, multidisciplinary research agenda of the Antibacterial Resistance Leadership Group (ARLG). In the original award period, the ARLG agenda increased scientific knowledge of antibacterial resistance and sought to mitigate important factors that drive its expansion. We continue to pair an unprecedented team of over two dozen of the world's top investigators with the organizational excellence of the Duke Clinical Research Institute (DCRI), one of the world's largest Academic Research Organizations. Because of the complexity of integrating multiple components of such a large-scale clinical research network, our renewal continues to feature centralized leadership through an Executive Committee and a dual PI approach. One PI (Fowler) focuses primarily on operations and the other (Chambers) focuses largely on scientific agenda. The organizational structure also features Scientific Subcommittees devoted to three priority areas: Gram-negative bacterial infections, Gram-positive bacterial infections, and Diagnostics. These Subcommittees are supported by internationally recognized Collaborating Investigators to advance four core value areas: 1) Scientific Expertise; 2) Innovations; 3) Mentoring and Diversity; and 4) Network Development. To complement the ongoing research activities of both the diagnostic and the pharmaceutical industries, our ARLG has established collaborative ties with members of both communities. Our long-term research goal is to improve outcomes of multiple-drug resistant (MDR) bacterial infections by designing and conducting transformational diagnostic and therapeutic clinical trials. Our research portfolio will pursue this goal in therapeutics by conducting first-in kind strategy trials in MDR Gram-negative bacteria and MRSA and by studying nontraditional therapeutics (monoclonal antibodies and bacteriophages) against MDR Pseudomonas aeruginosa. We will pursue this goal in diagnostics by obtaining FDA approval for a host gene expression-based diagnostic and by evaluating the clinical impact of rapid phenotypic testing in patients with bloodstream infection. Our research agenda reflects a realistic strategy of incremental steps towards complex practice-changing trials. Our Specific Aims are to 1) To maintain a Scientific Leadership Center (SLC) that provides overall scientific and administrative leadership for the network; 2) To maintain a Clinical Operations Center (COC) that provides operational support, management, and oversight for the network’s clinical studies and trials; 3) To maintain a Laboratory Center (LC) that advances the ARLG research agenda by leading the development, implementation, and evaluation of essential laboratory research; and 4): To maintain a Statistics and Data Management Center (SDMC) that advances the ARLG research agenda by providing leadership in biostatistics, study design, analysis, interpretation, and publication of results. By advancing these specific aims, our renewal will build upon the productivity and innovation assembled in our original award to advance the ARLG scientific agenda against one of the leading threats to human health.

我们的目标是继续推进抗菌药物的成功、多学科研究议程 抵抗领导小组（ARLG）。在最初的颁奖期间，ARLG 议程增加了科学性 了解抗菌素耐药性，并寻求减轻推动其扩张的重要因素。我们 继续将一支由两打以上世界顶尖研究人员组成的史无前例的团队与 杜克临床研究所 (DCRI) 的组织卓越，是世界上最大的学术机构之一 研究组织。由于集成如此大规模的多个组件的复杂性 临床研究网络，我们的更新继续以通过执行官的集中领导为特色 委员会和双重 PI 方法。一名 PI（福勒）主要负责运营，另一名 PI（钱伯斯）主要负责运营 主要关注科学议程。组织结构还设有科学小组委员会 致力于三个优先领域：革兰氏阴性细菌感染、革兰氏阳性细菌感染和 诊断。这些小组委员会得到国际公认的合作研究人员的支持，以 推进四个核心价值领域：1）科学专业知识； 2）创新； 3）指导和多元化；和 4) 网络发展。为了补充诊断和诊断领域正在进行的研究活动 在制药行业，我们的 ARLG 已与这两个行业的成员建立了合作关系。 我们的长期研究目标是通过以下方式改善多重耐药 (MDR) 细菌感染的结果 设计和进行转化诊断和治疗临床试验。我们的研究组合将 通过在耐多药革兰氏阴性细菌中进行首次同类策略试验来实现这一治疗目标 MRSA 并研究针对 MDR 的非传统疗法（单克隆抗体和噬菌体） 铜绿假单胞菌。我们将通过获得 FDA 对宿主基因的批准来实现这一诊断目标 基于表达的诊断并评估快速表型检测对患者的临床影响 血流感染。我们的研究议程反映了逐步迈向复杂的现实战略 改变实践的试验。我们的具体目标是 1) 维持一个科学领导中心 (SLC) 为网络提供全面的科学和行政领导； 2) 维持临床运作 为网络临床研究提供运营支持、管理和监督的中心 (COC) 和考验； 3) 维持一个实验室中心（LC），通过领导 ARLG 的研究议程来推进 ARLG 的研究议程。 基本实验室研究的开发、实施和评估； 4): 维护统计数据 和数据管理中心 (SDMC)，通过在以下领域发挥领导作用来推进 ARLG 研究议程： 生物统计学、研究设计、分析、解释和结果发布。通过推进这些具体 目标，我们的更新将建立在我们最初的奖项中汇集的生产力和创新的基础上，以推进 ARLG 的科学议程针对人类健康的主要威胁之一。