Mpox Paediatric and Adolescent Clinical Study

The goal of this multicentre, observational study on mpox in infants, children and adolescents is to increase knowledge about mpox infection and its associated disease in infants, children and adolescents. This will be done through the development of a harmonized system that will allow standard collection of information on demographics, clinical symptoms, clinical course, treatments and outcomes. The study will be carried out in three potential phases: Phase 1 entails the rapid development of an online paediatric registry collecting anonymised data from routine care on infants, children and adolescents with laboratory-confirmed mpox virus infection. If warranted, the study will proceed to Phase 2, an enhanced observational study of children and adolescents with confirmed mpox virus infection, if more detailed prospective data collection would aid the public health response. There is also the potential to initiate Phase 3, comprising of nested sub-studies to investigate specific research questions in this population.

Study Overview

• Status: Recruiting
• Conditions: Monkeypox; Monkey Pox

Detailed Description

The primary objective of this multicentre observational study is to use a harmonised data system for the standard data collection and analysis to describe the presentation, clinical course and outcomes of laboratory-confirmed mpox virus infection in infants, children and adolescents by:

1. monitoring the temporal and geographical distribution of mpox infection in the paediatric and adolescent population, including in specific paediatric/adolescent groups, such as those with underlying conditions or with congenital mpox;
2. describing the epidemiology and clinical presentation of the disease, including outcomes of treatment administered as part of routine care;
3. describing high risk populations , including identifying factors associated with severe disease and death.

Phase 1 consists of the rapid development of an online registry for standard collection of data on infants, children and adolescents with laboratory-confirmed mpox infection, including adolescent girls who acquired mpox in pregnancy, and infants who acquired mpox through vertical transmission. All data will be fully anonymised, allowing rapid implementation in many countries without the need for ethics approval, where applicable.

If additional data collection would aid the public health response, the investigators might additionally include a second phase (Phase 2) of the project, with the aim to implement an enhanced prospective observational study of children and adolescents with confirmed mpox infection. This part of the project, if activated, will be a consented study collecting detailed data over the course of the disease.

Phase 3: initiation of nested sub-studies within the consented observational study (Phase 2) to investigate specific research questions in this population, including collection of samples, where necessary, for analysis and/or storage in a biobank. Each sub-study will require its own protocol and informed consent.

The database, networks and systems developed within Phases 1 to 3 will be flexible and designed to be readily adapted to data collection for other emerging and re-emerging infections in children.

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Giorgia Dalla Valle; Phone Number: 393783022748; Email: giorgia.dallavalle@pentafoundation.org

Study Locations

• Greece
  • Athens, Greece
    • Not yet recruiting
    • P. and A. Kyriakou Children's Hospital
• Spain
  • Barcelona, Spain
    • Not yet recruiting
    • Hospital Germans Trias i Pujol
  • Madrid, Spain, 28007
    • Not yet recruiting
    • Hospital General Universitario Gregorio Marañon
  • Madrid, Spain, 28046
    • Recruiting
    • Hospital La Paz
    • Contact: Cristina Calvo
  • Madrid, Spain
    • Not yet recruiting
    • Hospital 12 de Octubre
  • Madrid, Spain
    • Not yet recruiting
    • Hospital Niño Jesús

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Infants, children and adolescents with laboratory-confirmed mpox infection, including adolescent girls who acquired mpox in pregnancy, and infants who acquired mpox through vertical transmission.

Phase 1 participants' consent may not be necessary as data collected is anonymous, phase 2 observational study participation would require participants'/ parent or legal representative consent as data collected is pseudonymised.

Description

Inclusion Criteria:

• all infants, children and adolescents aged <18 years at the time of mpox diagnosis, with laboratory-confirmed mpox infection, as per national guidelines;
• mothers of eligible infants who are diagnosed with mpox at 28days or less are included in the study to collect maternal data on pregnancy and delivery

Exclusion Criteria:

• adolescents aged over 18 years old at mpox diagnosis.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants with severe mpox.	Severe mpox infection as measured by, for example, mortality, ICU admission, receipt of interventions	Throughout study completion, expected 2 years from study start.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of infants born to women infected with mpox in pregnancy, who are vertically infected with mpox.	Amongst infants born to women infected with mpox during pregnancy, the number who are themselves diagnosed with mpox within 28 days of birth.	Throughout study completion, expected 2 years from study start.

Collaborators and Investigators

• Sponsor: PENTA Foundation
• Collaborators: University College, London; European Commission; Servicio Madrileño de Salud, Madrid, Spain; European University Cyprus

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2023
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: May 26, 2023
• First Submitted That Met QC Criteria: July 7, 2023
• First Posted (Actual): July 17, 2023

Study Record Updates

• Last Update Posted (Actual): July 17, 2023
• Last Update Submitted That Met QC Criteria: July 7, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Poxviridae Infections; Monkeypox
• Other Study ID Numbers: VERDI MPOX paediatric study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO