Monkeypox, Monkey Pox
Conditions
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.
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.
Interventions
None listed
Sponsors
PENTA Foundation
University College, London
European University Cyprus
Servicio Madrileño de Salud, Madrid, Spain
European Commission
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
0 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants With Severe Mpox. | Throughout the study period. Participants are enrolled over a period of 2 years 7 months, participants' outcomes are recorded at 28 days. | Severe mpox infection as measured by, for example, mortality, ICU admission, receipt of interventions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Infants Born to Women Infected With Mpox in Pregnancy, Who Are Vertically Infected With Mpox. | Throughout the study period. Participants are enrolled over a period of 2 years 7 months, participants' outcomes are recorded at 28 days. | Amongst infants born to women infected with mpox during pregnancy, the number who are themselves diagnosed with mpox within 28 days of birth. |
Countries
Democratic Republic of the Congo, Ghana, Mexico, Nigeria, Spain, United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 1108 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 8 years |
| Race/Ethnicity, Customized Ethnicity Black | 927 Participants |
| Race/Ethnicity, Customized Ethnicity Latin American | 29 Participants |
| Race/Ethnicity, Customized Ethnicity South Asian | 2 Participants |
| Race/Ethnicity, Customized Ethnicity White | 14 Participants |
| Region of Enrollment Congo, The Democratic Republic of the | 1007 participants |
| Region of Enrollment Ghana | 38 participants |
| Region of Enrollment Mexico | 26 participants |
| Region of Enrollment Nigeria | 5 participants |
| Region of Enrollment Spain | 31 participants |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 481 Participants |
| Sex: Female, Male Male | 624 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 1,108 |
| other Total, other adverse events | 0 / 1,108 |
| serious Total, serious adverse events | 0 / 1,108 |
Outcome results
None listed