Pediatric leishmaniasis in Italy: clinical and treatment patterns
Official title: A Multicenter Study on Leishmaniasis in Children: Clinical and Epidemiological Characteristics and Outcomes
Run by Meyer Children's Hospital IRCCS · NCT07504757 · Data updated 2026-11-12
This project will collect medical information to see how leishmaniasis presents and is treated in children under 18 in Italy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | Any age to 17 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Meyer Children's Hospital IRCCS Academic / other |
| Locations | 1 site (Florence, Tuscany) |
| Status | Recruiting |
| Started | January 30, 2025 |
| Main results expected | June 30, 2031 |
| Study ends | December 30, 2031 |
| Registry record updated | April 1, 2026 |
| Trial ID | NCT07504757 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children under 18 with a confirmed diagnosis of human leishmaniasis by WHO criteria whose parents or legal guardians provide written consent (and patient assent when applicable).
✕Probably not a fit
Patients who do not meet WHO diagnostic criteria, those without required consent, adults, or children unable to complete follow-up are unlikely to receive direct benefit from this project.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter observational project collects both retrospective and prospective data on children younger than 18 diagnosed with leishmaniasis according to WHO criteria at participating Italian centers. Investigators will record clinical presentations, diagnostic testing, epidemiologic history, treatments given, and outcomes from the baseline visit and during the first year of follow-up. No experimental interventions are administered; the work describes real-world care and outcomes. The aim is to improve knowledge of visceral, cutaneous, and mucocutaneous leishmaniasis in children to support earlier diagnosis and more consistent treatment approaches.
Why it matters
Potential benefit: If successful, the study could help clinicians diagnose leishmaniasis earlier and standardize treatments for children, potentially improving outcomes.
How similar studies have gone: Adult observational registries and regional case series have improved understanding of leishmaniasis, but large multicenter pediatric datasets are limited, so this effort addresses a known gap.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients younger than 18 years of age at the time of diagnosis * Diagnosis of human leishmaniasis according to World Health Organization (WHO) criteria * Written informed consent signed by parents or legal guardians; patient assent when applicable Exclusion Criteria: * Patients who do not meet the diagnostic criteria for confirmed human leishmaniasis * Lack of informed consent signed by parents or legal guardians, when required
Where it's running
-
AOU Meyer IRCCS
Florence, Tuscany, Italy Recruiting
Study contacts
- Study coordinator: Elisabetta Venturini, MD,Phd
- Email: elisabetta.venturini@meyer.it
- Phone: +39 3490920901
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.