We would like to invite hospitals to participate in a study of mpox in children and adolescents globally.
This mpox paediatric and adolescent clinical study is a Joint EU Clinical Research Initiative which is part of the VERDI project, in collaboration with VACCELERATE. The study aims to collect harmonised data on mpox virus infection in children and adolescents to enable epidemiological analysis of the combined dataset.
Why join the study?
The state of knowledge regarding the epidemiology, clinical presentation and outcomes of mpox disease in children and adolescents is limited. There is currently a need for a harmonised EU paediatric clinical protocol for standardised collection and analysis of data on mpox virus infection in this group.
For this reason, we are establishing a standard observational mpox data collection system (for collection of data on both retro- and prospective cases) with the initial goal of describing the presentation, clinical course, and outcomes of children and adolescents (0-17 years old at mpox diagnosis) with laboratory-confirmed mpox virus infection.
Overview of study procedures
- Phase 1: Collection of anonymised data from routine care on children and adolescents with laboratory-confirmed mpox virus infection. Requirement for ethics approvals dependant on local regulation. Starts in Q2 2023.
- Phase 2: Establishment of an enhanced observational cohort of children and adolescents with confirmed mpox virus infection. This will be a consented study collecting detailed pseudonymised data, including longer term follow-up through data linkage and / or direct patient contact. A site feasibility assessment will be performed prior to joining this phase of the study and local ethics approval will be required. The decision about whether to carry phase 2 will be based on the ongoing case numbers and the existence of other surveillance systems/studies.
- Phase 3: Potential sub-studies may be added for sites in phase 2. More information to be shared in due course.
How to participate in the study
All sites, including university, non-academic, tertiary care and community hospitals; with or without prior experience in carrying out research projects; who are or will be taking care of children or adolescents (as inpatients or outpatients) with confirmed mpox, are encouraged to express their interest in Phase 1 and / or Phase 2 of the study by completing this survey.
If you have not seen any cases of mpox at your site but do have cases in any possible future waves, we would be grateful if you could contact Giorgia Dalla Valle, Penta Clinical Project Manager (email@example.com) and join the registry at that time. Patient data will be collected until June 2024.
Please note that researchers contributing to the study will be included on study publications.
The Sponsor, Fondazione Penta ETS, will contact sites who express an interest in participating in the registry to check regulatory approval requirements and compliance after which access will be given to the online platform for phase 1.
Should you have any queries, please do not hesitate to contact Giorgia Dalla Valle, Penta Clinical Project Manager (firstname.lastname@example.org).
VERDI is a large consortium that prioritises pregnant women, children and high-risk populations in research on new SARS-CoV-2 variants of concern. It also focuses on preparedness for future infections outbreaks, building on experiences with COVID-19 and mpox.
Through a multidisciplinary global network, we want to improve the understanding of the epidemiology, transmission, disease progression and treatment of variants of SARS-CoV-2 among children and pregnant women, and of mpox in populations at higher risk of infection or severe disease, such as people living with or at high risk of HIV. We also aim to improve research preparedness, so that studies can be carried out quickly and efficiently during future outbreaks.
The VERDI project (101045989) is funded by the European Union. It is coordinated by the University of Padua and Fondazione Penta ETS (Italy), with scientific coordination shared between University of Padua and University College London.