Trial Outcomes & Findings for Mpox Paediatric and Adolescent Clinical Study (NCT NCT05947786)
NCT ID: NCT05947786
Last Updated: 2026-08-31
Results Overview
Severe mpox infection as measured by, for example, mortality, ICU admission, receipt of interventions
COMPLETED
1108 participants
Throughout the study period. Participants are enrolled over a period of 2 years 7 months, participants' outcomes are recorded at 28 days.
2026-08-31
Participant Flow
Participant milestones
| Measure |
Enrolled Infants, Children and Adolescents With Mpox
Total enrolled Infants, Children and Adolescents with Mpox (this is an observational study).
|
|---|---|
|
Overall Study
STARTED
|
1108
|
|
Overall Study
COMPLETED
|
1108
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sex was not recorded for 3 participants in this observational study.
Baseline characteristics by cohort
| Measure |
Total Study Population
n=1108 Participants
Total enrolled participants (this is an observational study).
|
|---|---|
|
Age, Categorical
<=18 years
|
1108 Participants
n=1108 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=1108 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=1108 Participants
|
|
Age, Continuous
|
8 years
n=1108 Participants
|
|
Sex: Female, Male
Female
|
481 Participants
n=1105 Participants • Sex was not recorded for 3 participants in this observational study.
|
|
Sex: Female, Male
Male
|
624 Participants
n=1105 Participants • Sex was not recorded for 3 participants in this observational study.
|
|
Race/Ethnicity, Customized
Ethnicity · Black
|
927 Participants
n=972 Participants • Ethnicity data was not recorded for 136 participants in this observational study.
|
|
Race/Ethnicity, Customized
Ethnicity · South Asian
|
2 Participants
n=972 Participants • Ethnicity data was not recorded for 136 participants in this observational study.
|
|
Race/Ethnicity, Customized
Ethnicity · Latin American
|
29 Participants
n=972 Participants • Ethnicity data was not recorded for 136 participants in this observational study.
|
|
Race/Ethnicity, Customized
Ethnicity · White
|
14 Participants
n=972 Participants • Ethnicity data was not recorded for 136 participants in this observational study.
|
|
Region of Enrollment
United States
|
1 participants
n=1108 Participants
|
|
Region of Enrollment
Congo, The Democratic Republic of the
|
1007 participants
n=1108 Participants
|
|
Region of Enrollment
Mexico
|
26 participants
n=1108 Participants
|
|
Region of Enrollment
Ghana
|
38 participants
n=1108 Participants
|
|
Region of Enrollment
Nigeria
|
5 participants
n=1108 Participants
|
|
Region of Enrollment
Spain
|
31 participants
n=1108 Participants
|
PRIMARY outcome
Timeframe: Throughout the study period. Participants are enrolled over a period of 2 years 7 months, participants' outcomes are recorded at 28 days.Population: In this observational study using routine care data (often retrospective), outcome data were not available for all participants. This is because routine care records available for research do not always include details of ICU or death within 28 days, the definition of severe mpox in this study. Hence of 1108 participants enrolled, 552 had data analysed for the primary outcome.
Severe mpox infection as measured by, for example, mortality, ICU admission, receipt of interventions
Outcome measures
| Measure |
Enrolled Infants, Children and Adolescents With Mpox
n=552 Participants
Total enrolled Infants, Children and Adolescents with Mpox(this is an observational study).
|
|---|---|
|
Proportion of Participants With Severe Mpox.
|
1 Participants
|
SECONDARY outcome
Timeframe: Throughout the study period. Participants are enrolled over a period of 2 years 7 months, participants' outcomes are recorded at 28 days.Population: This was an observational study in children and adolescents aged \<18 years at time of mpox diagnosis. This outcome was included in case any pregnant participants were enrolled, however, none of the participants were reported to be pregnant at enrolment and so it was not possible to assess vertical transmission.
Amongst infants born to women infected with mpox during pregnancy, the number who are themselves diagnosed with mpox within 28 days of birth.
Outcome measures
Outcome data not reported
Adverse Events
Total Study Population
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place