LEISH-PED: Study on Leishmaniasis in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Leishmania Infantum Disease, Leishmaniasis, Visceral, Leishmaniasis, Cutaneous, Leishmaniasis, Mucocutaneous. Basic parameters: up to 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter Study on Leishmaniasis in Children: Clinical and Epidemiological Characteristics and Outcomes
Overview
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.
Primary outcome measures
- Recovery rate according to therapeutic and diagnostic delay [Time frame: At diagnosis, 3, 6, 12 months from diagnosis]
- Death rate according to therapeutic and diagnostic delay [Time frame: At diagnosis, 3, 6, 12 months from diagnosis]
- Relapse rate according to therapeutic and diagnostic delay [Time frame: At diagnosis, 3, 6, 12 months from diagnosis]
- Severity of pediatric leishmaniasis [Time frame: At diagnosis, 3, 6, 12 months from diagnosis]
Secondary outcome measures (2)
- Risk factors for complicated forms of leishmaniasis [Time frame: From January 1, 2013 to June 30, 2026]
- Risk factors for relapse of leishmaniasis [Time frame: Baseline through 12 months of follow-up.]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- AOU Meyer IRCCS — Florence
Identifiers
NCT: NCT07504757 · LEISH-PED