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一个抗菌抵抗领导力小组（ARLG），该小组将开发，设计，实施和管理临床研究议程，以增加对驱动抵抗力的重要因素的了解并减轻知识。我们将将一个超过二十多名世界顶级研究人员的前所未有的团队与世界上最大的学术研究组织之一的杜克临床研究所（DCRI）的组织卓越相结合。由于整合了如此大规模临床研究网络的多个组成部分的复杂性，我们的提交通过执行委员会和双PI方法以集中的领导方式进行了集中的领导。一个PI（Fowler）主要关注运营，另一个PI（Chambers）主要集中在科学议程上。以ACTG为模型的组织结构还具有专门针对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，革兰氏阴性细菌感染以及诊断和装置。这些小组委员会得到了三个特殊重点小组（SEP）（儿科，药代动力学和特殊人群）和指导核心的支持。每个小组委员会，SEP和Core都包含国际认可的调查人员，以确保专业知识。为了补充NIH和制药生物技术行业的当前研究活动，我们的ARLG与两个社区成员建立了合作关系。 我们的长期目标是1）完成新反感染者的优势试验（要么是新代理人 或现有药物的新给药方案）用于MDR-Gram阴性细菌感染； 2）定义较短的过程，常见感染的狭窄光谱治疗方案是支持管理的主要手段； 3）测试鉴定抗菌剂的快速诊断 基于细菌中基因型标记的抗性； 4）确定MRSA感染的万古霉素的更有效替代品。研究议程反映了我们在早期研究中实现现实的，增量步骤的整体策略，这些策略将朝着更复杂的转化试验建立，这将改变临床实践并减少抗菌抗性的影响。