Antibacterial Resistance Leadership Group (ARLG)

抗菌素耐药性领导小组 (ARLG)

• 批准号: 8478367
• 负责人: Vance G. Fowler
• 金额: $ 200万
• 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 2019-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8478367
• 关键词: AIDS clinical trial group; Address; Anti-Infective Agents; Antimicrobial Resistance; Area; Bacteria; Bacterial Drug Resistance; Biometry; Biotechnology; Budgets; Clinical Research; Clinical Trials; Communities; Complement; Complex; Data Analyses; Development; Devices; Diagnostic; Disease; Doctor of Philosophy; Dose; Drug Kinetics; Ensure; Evaluation; Future; Goals; Gram-Negative Bacterial Infections; Gram-Positive Bacterial Infections; Health; Industry; Infection; Infection prevention; Knowledge; Laboratories; Laboratory Research; Lead; Leadership; Mentors; Modeling; National Institute of Allergy and Infectious Disease; New Agents; Pediatrics; Pharmacologic Substance; Pharmacotherapy; Phase; Principal Investigator; Publications; Regimen; Research; Research Activity; Research Design; Research Infrastructure; Research Institute; Research Personnel; Resistance; Resources; Services; Staging; Staphylococcal Infections; Techniques; Testing; Therapeutic; Time; United States National Institutes of Health; Vancomycin; antimicrobial; base; biobank; clinical practice; data management; design; experience; fundamental research; member; methicillin resistant Staphylococcus aureus; named group; novel diagnostics; operation; organizational structure; pressure; programs; statistics; success

DESCRIPTION (provided by applicant): Our goal is to create and implement an Antibacterial Resistance Leadership Group (ARLG) that will develop, design, implement, and manage a clinical research agenda that will increase knowledge of and mitigate the important factors that drive resistance. We will 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 submission features 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, modeled after that of the ACTG, also features Scientific Subcommittees devoted to four priority areas: Gram-negative bacterial infections, Stewardship and infection prevention, Gram-positive bacterial infections, and Diagnostics and devices. These Subcommittees are supported by three Special Emphasis Panels (SEPs) (Pediatrics, Pharmacokinetics, and Special Populations) and a Mentoring Core. Each Subcommittee, SEP, and Core contains internationally recognized investigators, ensuring expertise. To complement the current research activities of both NIH and the pharmaceutical biotechnology industry, our ARLG has established collaborative ties with members of both communities. Our long-term goals are 1) to complete a superiority trial of new anti-infectives (either new agent or new dosing regimen of existing agent) for MDR-Gram negative bacterial infections; 2) to define shorter course, narrow-spectrum therapeutic regimens for common infections as a principal means to support stewardship; 3) to test a rapid diagnostic that identifies antimicrobial resistance based on genotypic markers in bacteria; and 4) to identify a more effective alternative to vancomycin for MRSA infections. The research agenda reflects our overall strategy of making realistic, incremental steps in early phase studies upon which to build toward more complex transformational trials that will change clinical practice and reduce the impact of antibacterial resistance.

描述（由申请人提供）：我们的目标是创建和实施抗菌药物耐药性领导小组 (ARLG)，该小组将开发、设计、实施和管理临床研究议程，以增加对导致耐药性的重要因素的了解并减轻这些因素。我们将把一支由两打以上世界顶级研究人员组成的前所未有的团队与世界上最大的学术研究组织之一杜克临床研究所 (DCRI) 的卓越组织能力结合起来。由于整合如此大规模的临床研究网络的多个组成部分的复杂性，我们提交的材料具有通过执行委员会和双重 PI 方法进行集中领导的特点。一名 PI（福勒）主要关注运营，另一名 PI（钱伯斯）主要关注科学议程。该组织结构仿照 ACTG 的组织结构，还设有专门负责四个优先领域的科学小组委员会：革兰氏阴性细菌感染、管理和感染预防、革兰氏阳性细菌感染以及诊断和设备。这些小组委员会得到三个特别重点小组 (SEP)（儿科、药代动力学和特殊人群）和一个指导核心的支持。每个小组委员会、SEP 和核心委员会都包含国际公认的研究人员，以确保专业知识。为了补充 NIH 和制药生物技术行业当前的研究活动，我们的 ARLG 与两个社区的成员建立了合作关系。 我们的长期目标是 1) 完成新型抗感染药物（无论是新药还是新药）的优越性试验 或现有药物的新剂量方案）用于耐多药革兰氏阴性细菌感染； 2) 确定针对常见感染的较短疗程、窄谱治疗方案，作为支持管理工作的主要手段； 3) 测试识别抗菌药物的快速诊断 基于细菌基因型标记的耐药性； 4) 寻找一种更有效的万古霉素替代品来治疗 MRSA 感染。研究议程反映了我们在早期研究中采取现实、渐进步骤的总体战略，在此基础上进行更复杂的转化试验，从而改变临床实践并减少抗菌素耐药性的影响。