Mpox Paediatric and Adolescent Clinical Study

Monkeypox Clinical Trial

Official title:

Mpox Paediatric and Adolescent Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05947786
• Other study ID #: VERDI MPOX paediatric study
• Status: Recruiting
• Start date: March 17, 2023
• Est. completion date: July 31, 2025

Study information

• Verified date: July 2023
• Source: PENTA Foundation
• Contact: Giorgia Dalla Valle
• Phone: 393783022748
• Email: giorgia.dallavalle[@]pentafoundation.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Monkey Pox
• Monkeypox

Locations

Country	Name	City	State
Greece	P. and A. Kyriakou Children's Hospital	Athens
Spain	Hospital Germans Trias i Pujol	Barcelona
Spain	Hospital 12 de Octubre	Madrid
Spain	Hospital General Universitario Gregorio Marañón	Madrid
Spain	Hospital La Paz	Madrid
Spain	Hospital Niño Jesús	Madrid

Sponsors (5)

Lead Sponsor	Collaborator
PENTA Foundation	European Commission, European University Cyprus, Servicio Madrileño de Salud, Madrid, Spain, University College, London

Countries where clinical trial is conducted

Greece,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.