Mpox Paediatric and Adolescent Clinical Study

NCT05947786 | Unknown

• 1 other identifier: VERDI MPOX paediatric study
• Study Type: observational
• Target: 20
• Locations: 2 countries
• Sites: 6

Brief Summary

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.

Conditions

Monkey Pox; Monkeypox

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of infants born to women infected with mpox in pregnancy, who are vertically infected with mpox.

  Throughout study completion, expected 2 years from study start.

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• adolescents aged over 18 years old at mpox diagnosis.

Sponsors & Collaborators

• PENTA Foundation: lead
• University College, London: collaborator
• European University Cyprus: collaborator
• Servicio Madrileño de Salud, Madrid, Spain: collaborator
• European Commission: collaborator

Study Sites (6)

P. and A. Kyriakou Children's Hospital

Athens, Greece

NOT YET RECRUITING

Hospital Germans Trias i Pujol

Barcelona, Spain

NOT YET RECRUITING

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

NOT YET RECRUITING

Hospital La Paz

Madrid, 28046, Spain

RECRUITING

Hospital 12 de Octubre

Madrid, Spain

NOT YET RECRUITING

Hospital Niño Jesús

Madrid, Spain

NOT YET RECRUITING

MeSH Terms

Conditions

Mpox, Monkeypox

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Primate Diseases; Animal Diseases; Rodent Diseases

Central Study Contacts

Giorgia Dalla Valle

CONTACT

393783022748; giorgia.dallavalle@pentafoundation.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: July 17, 2023
• Study Start: March 17, 2023
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: July 17, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (5); GR (1)