LEISH-PED: Study on Leishmaniasis in Children

Recruiting now

Conditions studied: Leishmania Infantum Disease, Leishmaniasis, Visceral, Leishmaniasis, Cutaneous, Leishmaniasis, Mucocutaneous

In brief

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.

Key facts

Study ID

NCT07504757

Run by

Meyer Children's Hospital IRCCS

People needed

200

Starts

2025-01-30

Expected to finish

2031-12-30

Last updated by the study team

2026-04-01

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

• 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 is running

• AOU Meyer IRCCS — Florence, Tuscany, Italy (enrolling)

Full record on ClinicalTrials.gov

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