Actively Recruiting
LEISH-PED: Study on Leishmaniasis in Children
Led by Meyer Children's Hospital IRCCS · Updated on 2026-04-01
200
Participants Needed
1
Research Sites
360 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Leishmaniasis is an infection caused by Leishmania parasites. In children, it can affect the skin or internal organs. Diagnosis may be delayed because the signs and symptoms can be similar to those of other conditions. Delayed diagnosis or treatment may lead to worse outcomes. Treatment approaches, especially for cutaneous leishmaniasis, may also vary across centers. This study aims to improve knowledge about pediatric leishmaniasis in Italy. This is a multicenter observational study in children younger than 18 years of age with a diagnosis of human leishmaniasis according to World Health Organization criteria. The study includes both retrospective and prospective data from participating centers in Italy. Researchers will collect and analyze clinical, diagnostic, epidemiological, treatment, and outcome data from the baseline visit and from follow-up during the first year. The main goal of the study is to describe the clinical and epidemiological features of pediatric leishmaniasis in Italy over the study period, with a particular focus on diagnostic and treatment delay and on patient outcomes. The study will also assess the frequency and severity of disease over time and compare outcomes associated with different treatment approaches, particularly in cutaneous leishmaniasis. Patients evaluated between January 1, 2013 and June 30, 2031 may be included.
CONDITIONS
Official Title
LEISH-PED: Study on Leishmaniasis in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Patients who do not meet the diagnostic criteria for confirmed human leishmaniasis
- Lack of informed consent signed by parents or legal guardians, when required
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
AOU Meyer IRCCS
Florence, Tuscany, Italy, 50139
Actively Recruiting
Research Team
E
Elisabetta Venturini, MD,Phd
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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