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: 7774915
• 负责人: Kathryn Margaret Edwards
• 金额: $ 100万
• 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 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7774915
• 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（由申请方提供）：作为本研究项目的协调中心，范德比尔特大学医学中心疫苗研究项目（VUMC-VVRP）将负责在范德比尔特大学医院（门罗Carell Jr）全面开展本研究。范德比尔特儿童医院、浸信会医院、圣托马斯医院和峰会医疗中心。 每个研究中心的研究人员都提供了支持信，描述了他们在本研究项目中的角色，这些信包含在我们的申请包中。 在本项目执行过程中，VUMC-VVRP法规合规团队将与主要研究者合作，在整个执行期间提供文件控制。在此过程中，合规团队将向相应的IRB提交所有文件，并将IRB批准的方案、知情同意文件、病例报告表和其他关键文件分发给所有临床试验机构的关键人员。 此外，在研究项目实施前，合规经理、质量保证经理和研究协调员将向所有医院的工作人员提供强制性研究特定培训。 知情同意过程将由主要研究者和研究协调员进行稽查，并在整个入组期间进行相应记录，还将对恢复期访视进行进一步稽查。 此外，研究协调员将在研究入组阶段每周与护士和研究协调员建立并举行一次常设会议。这些会议旨在讨论每个研究中心的目标和当前入组情况，以及在一周内遇到的任何障碍。 质量控制稽查将由VUMC-VVRP质量保证经理执行，绩效计划包含在本申请的附录中。根据协调员会议和质量审计的结果，将根据需要提供额外的培训。 将通过圣托马斯研究所与浸信会和圣托马斯医院签订分包合同。 STRI的组织结构和治理的副本也包括在我们的应用程序中。 所有致力于该项目的工作人员将遵循联邦努力报告准则，未经资助机构事先批准，不得加班。 与STRI的合作将以成本补偿为基础，合同工作人员将被要求在收到范德比尔特大学医学中心的资金之前提供工作人员工作时间的充分文件。 公共卫生关系：在这项研究中，我们将招募1000名成年人和300名儿童，他们因肺炎住院，并通过胸部X光检查确诊，以了解该地区肺炎的总体发病率、致病微生物以及流感感染对肺炎发病率的影响。