The Incidence and Etiology of Influenza-Associated Pneumonia in Hospitalized Pers

住院患者流感相关肺炎的发病率和病因

• 批准号: 7930726
• 负责人: Kathryn Margaret Edwards
• 金额: $ 99.58万
• 依托单位: VANDERBILT UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-01 至 2012-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7930726
• 关键词: Incidence; Etiology; Influenza; Associated; Pneumonia

DESCRIPTION (provided by applicant): As the coordinating center for this research project, the Vanderbilt University Medical Center Vaccine Research Program (VUMC-VVRP) will be responsible for the overall conduct of the study at Vanderbilt University Hospital, Monroe Carell Jr. Children's Hospital at Vanderbilt, Baptist Hospital, St. Thomas Hospital, and Summit Medical Center. Site investigators at each of these sites have provided letters of support describing their roles in this research project and those letters are included in our application packet. During the course of this project, the VUMC-VVRP Regulatory Compliance team will work with the principal investigator to provide document control throughout the performance period. In this role, the compliance team will submit all documents to the respective IRBs and distribute IRB-approved protocols, informed consent documents, case report forms, and other critical documents to key personnel at all performance sites. Additionally, the compliance manager, quality assurance manager, and study coordinator will provide mandatory study-specific training to staff at all hospitals prior to the implementation of the research project. The informed consent process will be audited by the principal investigator and study coordinator and documented accordingly throughout the enrollment period and further auditing of convalescent visits will be performed as well. Additionally, the study coordinator will establish and hold standing meetings with the nurses and research coordinators on a weekly basis during the enrollment phase of the study. These meetings will be designed to discuss target and current enrollment for each site, as well as any barriers encountered during the week. Quality control audits will be performed by the VUMC-VVRP quality assurance manager and the performance plan is included in the appendix of this application. Additional training will be provided as needed based on findings from the coordinator meetings and the quality audits. Subcontracts will be established with Baptist and St. Thomas Hospitals through the St. Thomas Research Institute (STRI). A copy of the organizational structure and governance of STRI is also included in our application. All staff dedicated to this project will follow federal effort reporting guidelines and overtime will not be allowed without prior approval from the funding agency. The subcontract with STRI will be cost-reimbursement based and contracting staff will be required to provide adequate documentation of time worked by staff prior to receiving funds from Vanderbilt University Medical Center. PUBLIC HEALTH RELEVANCE: In this study we will enroll 1000 adults and 300 children hospitalized with pneumonia that is confirmed by chest X-ray to find the overall rates of pneumonia in the area, the microbes responsible, and the impact of influenza infection on pneumonia rates.

描述（由申请人提供）：作为该研究项目的协调中心，Vanderbilt大学医学中心疫苗研究计划（VUMC-VVRP）将负责该研究的整体进行，该研究的整体行为在Monroe Carell Carell Jr. Monroe Carell Jr.儿童医院的范德比尔特医院，范德比尔特医院，圣托马斯医院，圣托马斯医院，和山顶医疗中心。 这些站点中每个站点的现场调查人员都提供了支持信，以描述其在该研究项目中的作用，并且这些信件包含在我们的应用程序包中。 在该项目的过程中，VUMC-VVRP监管合规性团队将与主要研究人员合作，在整个绩效期间提供文档控制。在此职位上，合规团队将向相应的IRB提交所有文件，并分发由IRB批准的协议，知情同意文件，案例报告表和其他关键文件，向所有绩效站点的关键人员。 此外，合规经理，质量保证经理和研究协调员将在实施研究项目之前向所有医院的员工提供强制性的研究培训。 首席研究员和研究协调员将审核知情同意程序，并在整个入学期间进行了相应的记录，并将对康复访问进行进一步审核。 此外，在研究阶段，研究协调员将每周与护士和研究协调员建立并举行会议。这些会议将旨在讨论每个站点的目标和当前注册，以及一周中遇到的任何障碍。 VUMC-VVRP质量保证经理将进行质量控制审核，并且该应用程序的附录中包括性能计划。根据协调会议和质量审核的发现，将根据需要提供其他培训。 分包合同将通过圣托马斯研究所（Stri）与浸信会和圣托马斯医院建立。 我们的应用程序中还包括了组织结构和治理的副本。 所有致力于该项目的员工都将遵循联邦努力报告指南，未经资助机构事先批准，将不允许加班。 与Stri的分包合同将是基于费用的基于费用的，并且将要求承包人员提供足够的时间，以便在从范德比尔特大学医学中心收到资金之前，工作人员工作的时间有足够的时间。 公共卫生相关性：在这项研究中，我们将招募1000名成人和300名患有肺炎住院的儿童，这些儿童已由胸部X射线确认，以找到该地区的肺炎，负责的微生物以及流感感染对肺炎率的影响。