Antibacterial Resistance Leadership Group (ARLG)

抗菌素耐药性领导小组 (ARLG)

• 批准号: 10542803
• 负责人: Vance G. Fowler
• 金额: $ 1467.56万
• 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/10542803
• 关键词: Address; Area; Award; Bacteria; Bacterial Drug Resistance; Bacterial Infections; Bacteriophages; Biometry; Childhood; Clinical; Clinical Research; Clinical Trials; Clinical Trials Network; Collaborations; Communities; Complement; Complex; Data Analyses; Data Coordinating Center; Development; Diagnostic; Diagnostic tests; Drug Industry; Drug resistant Pseudomonas aeruginosa; Ensure; Evaluation; Gene Expression; Genital; Genitalia; 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; Learning; Mentors; Messenger RNA; Methodology; Molecular Epidemiology; Monoclonal Antibodies; 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; Training; Training Support; United States Food and Drug Administration; Viral; World Health Organization; bacterial resistance; biobank; clinical diagnostics; clinical epidemiology; 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 group

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 抵抗运动领导小组。在最初的颁奖期间，ARLG议程增加了科学性， 了解抗菌药物耐药性，并试图减轻推动其扩张的重要因素。我们 继续将一支由二十多名世界顶级调查人员组成的前所未有的团队与 杜克临床研究所（DCRI）是世界上最大的学术研究机构之一， 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，我们的更新继续通过执行集中领导的特点 委员会和双重PI方法。一个PI（福勒）主要侧重于业务，另一个（钱伯斯） 主要集中在科学议程。组织结构还包括科学小组委员会 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， 诊断。这些小组委员会得到国际公认的合作研究者的支持， 推进四个核心价值领域：1）科学专业知识; 2）创新; 3）指导和多样性; 4） 网络开发。为了补充正在进行的诊断和 在制药行业，我们的ARLG与两个社区的成员建立了合作关系。 我们的长期研究目标是改善多重耐药（MDR）细菌感染的结果， 设计和开展转型诊断和治疗临床试验。我们的研究组合将 通过在MDR革兰氏阴性菌中进行首次同类策略试验来实现这一治疗目标， MRSA和研究非传统疗法（单克隆抗体和噬菌体）对MDR 绿脓杆菌。我们将通过获得FDA对宿主基因的批准来实现诊断学的这一目标 表达为基础的诊断，并通过评估快速表型检测的临床影响， 血液感染我们的研究议程反映了一个现实的战略，逐步走向复杂的 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）维持临床运营 中心（COC），为网络的临床研究提供运营支持、管理和监督 3）维持一个实验室中心（LC），通过领导ARLG的研究议程， 发展，实施和评估基本实验室研究;和4）：保持统计 和数据管理中心（SDMC），通过在以下方面提供领导，推进ARLG的研究议程 生物统计学、研究设计、分析、解释和结果发表。通过推进这些具体的 目标，我们的更新将建立在生产力和创新组装在我们原来的奖项，以推进 ARLG的科学议程针对人类健康的主要威胁之一。