Observational study on mpox in children and adolescents
Mpox Paediatric and Adolescent Clinical Study
This study is trying to learn more about mpox infections in kids and teens by collecting important health information to better understand how the disease affects them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 0 Years to 18 Years |
| Sex | All |
| Sponsor | PENTA Foundation Research network |
| Locations | 6 sites (Athens and 5 other locations) |
| Trial ID | NCT05947786 on ClinicalTrials.gov |
What this trial studies
This multicentre observational study aims to enhance understanding of mpox infection in infants, children, and adolescents by developing a standardized system for collecting demographic and clinical data. The study will begin with the creation of an online registry to gather anonymized information on patients with laboratory-confirmed mpox infections. If necessary, the study may progress to an enhanced observational phase to collect more detailed data and potentially include sub-studies focused on specific research questions. The goal is to monitor the disease's epidemiology, clinical presentation, and outcomes, particularly in high-risk populations.
Who should consider this trial
Good fit: Ideal candidates include infants, children, and adolescents under 18 years old with laboratory-confirmed mpox infection.
Not a fit: Patients over 18 years old at the time of mpox diagnosis will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of mpox infections in young patients.
How similar studies have performed: Other studies on infectious diseases in pediatric populations have shown success in using similar observational approaches, indicating potential for valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Athens and 5 other locations
- P. and A. Kyriakou Children's Hospital — Athens, Greece (Not_yet_recruiting)
- Hospital Germans Trias i Pujol — Barcelona, Spain (Not_yet_recruiting)
- Hospital General Universitario Gregorio Marañón — Madrid, Spain (Not_yet_recruiting)
- Hospital La Paz — Madrid, Spain (Recruiting)
- Hospital 12 de Octubre — Madrid, Spain (Not_yet_recruiting)
- Hospital Niño Jesús — Madrid, Spain (Not_yet_recruiting)
Study contacts
- Study coordinator: Giorgia Dalla Valle
- Email: giorgia.dallavalle@pentafoundation.org
- Phone: 393783022748
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.