Mpox Paediatric and Adolescent Clinical Study
Study Overview
Status
Conditions
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:
- 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;
- describing the epidemiology and clinical presentation of the disease, including outcomes of treatment administered as part of routine care;
- 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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Kinshasa, Democratic Republic of the Congo
- University of Kinshasa
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Accra, Ghana
- Noguchi Memorial Institute for Medical Research
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Mexico City, Mexico
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
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Abuja, Nigeria
- Institute of Human Virology Nigeria
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Madrid, Spain
- Hospital La Paz
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Washington
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Seattle, Washington, United States, 98105
- Seattle Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
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?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Proportion of Participants With Severe Mpox.
Time Frame: Throughout the study period. Participants are enrolled over a period of 2 years 7 months, participants' outcomes are recorded at 28 days.
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Severe mpox infection as measured by, for example, mortality, ICU admission, receipt of interventions
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Throughout the study period. Participants are enrolled over a period of 2 years 7 months, participants' outcomes are recorded at 28 days.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Infants Born to Women Infected With Mpox in Pregnancy, Who Are Vertically Infected With Mpox.
Time Frame: Throughout the study period. Participants are enrolled over a period of 2 years 7 months, participants' outcomes are recorded at 28 days.
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Amongst infants born to women infected with mpox during pregnancy, the number who are themselves diagnosed with mpox within 28 days of birth.
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Throughout the study period. Participants are enrolled over a period of 2 years 7 months, participants' outcomes are recorded at 28 days.
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VERDI MPOX paediatric study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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