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Congenital and Perinatal Infections Rare Diseases Clinical Research Consortium (RDCRC)

先天性和围产期感染罕见疾病临床研究联盟 (RDCRC)

基本信息

批准号：
10465116
负责人：
DAVID W KIMBERLIN
金额：
$ 137.68万
依托单位：
UNIVERSITY OF ALABAMA AT BIRMINGHAM
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-09-01 至 2025-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10465116
关键词：
2 year old Alabama Antiviral Agents Antiviral Therapy Area Blindness Cardiac Cessation of life Child Care Childhood Clinical Clinical Research Cloud Computing Collaborations Common Data Element Communicable Diseases Communities Congenital herpes simplex Cytomegalovirus Data Data Coordinating Center Development Diagnosis Disease Dose Drug Kinetics Enrollment Enterovirus Exposure to Faculty Family Funding Future Future Generations Goals Health Hearing Herpes Simplex Infections Human Industry Infection Infrastructure Institution Lead Longitudinal Studies Mentors Modeling Morbidity - disease rate Motor Multi-site clinical study Natural History Neonatal Neonatal Mortality Neurologic Organ Outcome Parechovirus Pathogenicity Patient Care Perinatal Perinatal Infection Population Positioning Attribute Randomized Rare Diseases Recording of previous events Research Research Personnel Research Project Grants Resources Science Sepsis Septic Shock Series Simplexvirus Site Testing Therapeutic Agents Time Training United States Food and Drug Administration United States National Institutes of Health Universities Valganciclovir Viral Viremia Virus Virus Diseases Visceral Work burden of illness career career development clinical development clinical trial readiness congenital cytomegalovirus congenital infection data standards experience hearing impairment improved improved outcome infancy infant infection mortality neonatal sepsis neonate novel therapeutics pathogenic virus pharmacometrics phase 1 study programs recruit research and development respiratory success treatment effect trial design valacyclovir

项目摘要

The overall goal of the Congenital and Perinatal Infections Consortium (CPIC) is to establish infrastructure and institutional cooperation – focusing on rare congenital and perinatal viral infections – to advance understanding of these diseases, improve clinical trial readiness, test therapies, advance patient care, and ultimately reduce disease burden. These infections include congenital cytomegalovirus (CMV) disease, neonatal herpes simplex virus (HSV) infection, and neonatal viral sepsis caused by enteroviruses (EVs) and the related human parechoviruses (HPeVs). Led by researchers at the University of Alabama at Birmingham (UAB) and supported by an experienced and highly efficient study team, the 28 study sites that will comprise the CPIC have cooperated closely for decades as the Collaborative Antiviral Study Group (CASG) to investigate the natural history and treatment of rare congenital and perinatal infectious diseases. These longstanding relationships, as well as partnerships with community and industry stakeholders, will facilitate the success of our research efforts and our mentored career enhancement activities. As with all successful research programs, answers to critical questions always lead to identification of the next important questions that will further advance the field. These questions are the basis of the CPIC research portfolio that will advance the care of children with rare neonatal viral infections and provide experiential mentored research opportunities as we train the future generation of rare diseases researchers. Aims of the CPIC are: 1) to build upon clinical research advances achieved by the CASG to further advance the diagnosis, treatment, and understanding of HSV, CMV, and EV in the neonatal population; 2) to leverage longstanding relationships across the 28 CPIC study sites and with stakeholders to conduct clinical research projects with the highest of fidelity to all research standards; 3) to advance rare diseases research by sharing standardized data through close partnership with the Data Management and Coordinating Center and by utilizing cloud computing capacities and Common Data Elements; 4) to develop and utilize pilot and feasibility funding to leverage existing institutional resources and maximize its impact on the advancement of the science related to rare infectious diseases impacting neonates; and 5) to support mentored research and career enhancement opportunities for clinical fellows and junior faculty to facilitate the development of early-stage investigators in rare diseases research. Our Consortium will bring value to the Rare Diseases Clinical Research Network by promoting unique understanding of these diseases, and by providing both a time-tested research model and advanced pharmacometric expertise.

先天性和围产期感染联合会（CPIC）的总体目标是建立基础设施和