Mpox Paediatric and Adolescent Clinical Study
Study profileDescription
The VERDI Mpox Paediatric and Adolescent Clinical Study (or “Paediatric Registry”) established a standardised data collection system to describe the presentation, clinical course, and outcomes of laboratory-confirmed mpox infection in infants, children, and adolescents. Data submission was open globally, subject to local ethical and regulatory approvals. All data was collected as part of routine clinical care.
Sponsor: Fondazione Penta ETS
Countries involved: Democratic Republic of the Congo, Ghana, Mexico, Nigeria, Spain, USA
Sample size: 1108 children
Metadata collected
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| Data collected? | |
| Demographics | |
| Date of birth | |
| Age at contact | ✅ |
| Sex | ✅ |
| Gender | ✅ |
| Ethnic group | ✅ |
| Locality (of registration/ health care setting) | ✅ |
| Locality of residence | |
| Health status and exposures | |
| Height | ✅ |
| Weight | ✅ |
| Date of anthropometrics | ✅ |
| HIV status, timing of HIV diagnosis | ✅ o |
| HIV treatment | ✅ |
| HIV pre-exposure prophylaxis | |
| HIV-related lab tests (HIV RNA, CD4) | |
| Other co-morbid conditions / co-infections | ✅ |
| Medications for other chronic conditions | ✅ |
| Current smoker | ✅ |
| Risk factors for mpox acquisition | ✅ |
| °diagnosis date not available | |
| Mpox/other infections presentation, symptoms, medications, hospitalisation | |
| Date of symptom onset | ✅ °° |
| Signs and symptoms | ✅ |
| Lesion assessment | ✅ |
| Lesion resolution | |
| Outpatient facility presentation dates | ✅ °° |
| Hospitalisation dates | ✅ °° |
| ICU admission | ✅ |
| Procedures and dates | ✅ °°° |
| Complications | ✅ |
| Medications (type, dates / duration) | ✅ |
| Medical management | |
| Imaging findings* | ✅ |
| Severe disease indicators | |
| °° dates are not collected but timing is measured as year/week or in relation to presentation; °°° procedures dates not available | |
| Mpox/ other infections outcomes, death | |
| Outcome at discharge from care | ✅ |
| Sequelae | ✅ |
| Date of / age at death | ✅ |
| Cause of death | ✅ # |
| Place of death (i.e., setting) | ✅ # |
| # subset only (maternal record) | |
| Vaccines | |
| Mpox / orthopoxvirus vaccine doses and dates | ✅ |
| Vaccine administration route | ✅ |
| Vaccine history | ✅ # |
| # subset only (maternal record) | |
| Pregnancy & birth | |
| Pregnancy dates, length of gestation | ✅ |
| Number of foetuses | ✅ |
| Maternal age at delivery | ✅ |
| Pregnancy complications | ✅ |
| Pregnancy outcome | ✅ |
| Medications in pregnancy | ✅ |
| Vaccines in pregnancy | ✅ |
| Parity / gravidity | ✅ |
| Smoking | ✅ |
| Mpox testing in pregnancy | ✅ |
| Mode of delivery | ✅ |
| Sex of baby | ✅ |
| Infant anthropometrics at birth | ✅ |
| Congenital anomalies | ✅ |
| Mpox/ other infections diagnostics | |
| Sample type | ✅ |
| Sample date | |
| Type of PCR test | ✅ |
| PCR test date | |
| PCR result pos / neg | ✅ |
| PCR Ct value | ✅ |
| Type of serology test | ✅ |
| Serology test date | |
| Serology result | ✅ |
| Other lab tests | ✅ |
| Mpox/ other infections sample collection / storage | |
| Sample type collected | |
| Sample collection date | |
| Sample collection time | |
| Sample processing | |
| Sample quality | |
| Consent to use research sample | |
| Consent to share research sample | |