News and Events
I am pleased to report that, as more and more people are getting vaccinated for COVID-19, life is beginning to return to normal. For CPIC, this means our returning to the office on May 10th and a renewed focus on regular meetings and updates. Though COVID has had a significant impact on all researchers, probably none have been affected more than those of us working in infectious disease research.
The Congenital and Perinatal Infections Consortium (CPIC) brings together a coalition of 29 academic medical centers that have a longstanding history of research in pediatric infectious diseases with community and industry stakeholders. It is one of five new consortia to join the Rare Diseases Clinical Research Network in the latest funding cycle. Here, CPIC leaders share insights on the group’s goals, research projects, and next steps.
I hope everyone is feeling refreshed after the holiday season with family and friends, albeit a socially- distanced one. We are pleased to announce that our Neonatal EV Sepsis natural history study is now active at 19 sites. Congratulations to Cook Children’s Hospital (Dr. Susan Whitworth, PI) for enrolling the first subject on the DMID 19-0026-(EVNH) study. We will be following these neonates, who present with clinical signs and laboratory data consistent with viral sepsis, for three months to determine morbidity and mortality, and to explore quantitative changes in the causative virus over time.
Nov 20 Webinar: Congenital CMV: The Parent’s Perspective Join us on Friday Nov 20 at 11 am Central time for a webinar titled “Congenital Cytomegalovirus (CMV): The Parent’s Perspective,” featuring presentations by two parents and patient advocates: Kristen Hutchinson Spytek and Kathleen Muldoon, PhD.
We are pleased to announce that our Neonatal EV Sepsis protocol is active at 12 sites. In addition, we are hopeful that our Valacyclovir PK and Longitudinal CMV protocols will be initiated by late 2020 or early 2021. The Valacyclovir PK study synopsis was reviewed by the NIAID/DMID Clinical Science Review Committee on 10/20 and received favorable feedback. Full comments are expected soon, clearing the way for protocol development and selection of the 5 sites. More on site selection to follow.
In our initial RPPR, submitted for the 7/1 deadline, we reported extensive involvement with the Data Management and Coordinating Center (DMCC) including their agreement to use our Neonatal EV Sepsis natural history protocol to pilot test how the Cincinnati Children’s Hospital Medical Center IRB might serve as the single IRB of record for Rare Diseases Clinical Research Network (RDCRN) sites. We also worked with the DMCC to explore the possibility of developing and leading an International Congenital CMV Registry and to develop online content for the RDCRN website.
Until mid-March the CPIC Central Unit was operating as usual. Though we are continuing to work on Consortium activities, as detailed in this eBrief, most of us are working remotely and connecting by Zoom or WebEx to continue making progress. We are continuing to bring our 27 other sites on board by executing subawards and are also in the process of finalizing IRB reliance at all sites.
We are excited that CPIC will soon begin implementing our research projects as part of the Rare Diseases Clinical Research Network (RDCRN). As we begin the work of our Consortium, we want to distribute important information and updates to all sites in a consistent and concise way. We will have monthly calls with PIs and study teams to discuss protocols once the studies are active, but will use this eBrief format to share additional information. Please note that each issue will include the status of our four research projects, as well as updates related to the Career Enhancement Core and the Pilot and Feasibility Core. We will also include contact information for key personnel, as well as any relevant regulatory or financial updates.
University of Alabama at Birmingham investigators within the Division of Pediatric Infectious Diseases have received a $5 million, five-year U54 grant from the National Institute of Allergy and Infectious Diseases to establish the Congenital and Perinatal Infections Consortium, part of the Rare Diseases Clinical Research Network.