The European Academy of Paediatrics (EAP) is pleased to share an invitation to participate in the Paediatric Isavuconazole Registry (Ped-IR), an international, investigator-initiated research project coordinated within the FungiScope framework.
This initiative addresses an important evidence gap in paediatric care by collecting real-world data on the use of isavuconazole in children with invasive mould disease. EAP is distributing this call to its members to support broad academic engagement and to facilitate dissemination to relevant paediatric centres across Europe and beyond.
This initiative forms part of the European Commission–UNICEF three-year partnership to promote a comprehensive, prevention-oriented approach to children’s health
The project will result in the development of a Toolkit for Child and Adolescent Health and Mental Wellbeing Promotion, designed to support policymakers in strengthening national strategies and cross-sector collaboration.
Ped-IR is a global, retrospective, multinational observational study focusing on children and adolescents treated with isavuconazole for proven, probable, or possible invasive mould infections from 1 January 2024 onwards.
Data are collected via a fully anonymised electronic case report form, with no interventions or biological sampling required.
EAP members working in paediatric infectious diseases, haematology/oncology, and transplant medicine are invited to:
All contributing investigators will be acknowledged with authorship in resulting scientific publications, in line with academic standards.
The study is supported by a global research grant from Pfizer. The project is investigator-initiated and academically led. The sponsor has no involvement in study design, data collection, analysis, interpretation, or publication decisions.
Interested in participating or learning more?
Centres interested in participating can request the full study protocol, ethics framework, and registry documentation directly from the study coordinators:
Prof. Zoi-Dorothea Pana – [email protected]
Dr. Danila Seidel – [email protected]
New ways to test high-risk medical devices.
Manufacturers of medical devices need to test their products before being allowed to market them. Specifically, they require clinical data showing their medical device is safe and efficient. In this context, the EU-funded CORE-MD project will translate expert scientific and clinical evidence on study designs for evaluating high-risk medical devices into advice for EU regulators. The project will propose how new trial designs can contribute and suggest ways to aggregate real-world data from medical device registries.
It will also conduct multidisciplinary workshops to propose a hierarchy of levels of evidence from clinical investigations, as well as educational and training objectives for all stakeholders, to build expertise in regulatory science in Europe. CORE–MD will translate expert scientific and clinical evidence on study designs for evaluating high-risk medical devices into advice for EU regulators, to achieve an appropriate balance between innovation, safety, and effectiveness. A unique collaboration between medical associations, regulatory agencies, notified bodies, academic institutions, patients’ groups, and health technology assessment agencies, will systematically review methodologies for the clinical investigation of high-risk medical devices, recommend how new trial designs can contribute, and advise on methods for aggregating real-world data from medical device registries with experience from clinical practice The consortium is led by the European Society of Cardiology and the European Federation of National Associations of Orthopaedics and Traumatology, and involves all 33 specialist medical associations that are members of the Biomedical Alliance in Europe.
