An observational study in Monkey Pox and Monkeypox, sponsored by PENTA Foundation. Completed at 6 sites in 6 countries. Open to participants aged 0 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by PENTA Foundation · Observational
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.
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:
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.
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.
Exclusion Criteria:
Proportion of Participants With Severe Mpox.
Severe mpox infection as measured by, for example, mortality, ICU admission, receipt of interventions
Time frame: Throughout the study period. Participants are enrolled over a period of 2 years 7 months, participants' outcomes are recorded at 28 days.
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.
Time frame: Throughout the study period. Participants are enrolled over a period of 2 years 7 months, participants' outcomes are recorded at 28 days.
| Milestone | Enrolled Infants, Children and Adolescents With Mpox |
|---|---|
| Started | 1108 |
| Completed | 1108 |
| Not completed | 0 |
Severe mpox infection as measured by, for example, mortality, ICU admission, receipt of interventions
| Participants | Enrolled Infants, Children and Adolescents With Mpox |
|---|---|
| Proportion of Participants With Severe Mpox. | 1 |
Amongst infants born to women infected with mpox during pregnancy, the number who are themselves diagnosed with mpox within 28 days of birth.
No measurements were reported for this outcome.
Collected over Throughout the study period. Participants are enrolled over a period of 2 years 7 months, participants' outcomes are recorded at 28 days.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Total Study Population | 1/1,108 (0.1%) | 0/1,108 (0%) | 0/1,108 (0%) |
| Age, Categorical(Participants) | Total Study Population |
|---|---|
| <=18 years | 1108 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Age, Continuous(years) | Total Study Population |
|---|---|
| Median | 8 (4 to 13) |
| Sex: Female, Male(Participants) | Total Study Population |
|---|---|
| Female | 481 |
| Male | 624 |
| Race/Ethnicity, Customized(Participants) | Total Study Population |
|---|---|
| Ethnicity — Black | 927 |
| Ethnicity — South Asian | 2 |
| Ethnicity — Latin American | 29 |
| Ethnicity — White | 14 |
| Region of Enrollment(participants) | Total Study Population |
|---|---|
| United States | 1 |
| Congo, The Democratic Republic of the | 1007 |
| Mexico | 26 |
| Ghana | 38 |
| Nigeria | 5 |
| Spain | 31 |
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Plan to share: No
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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PENTA Foundation