An observational study in Leishmania Infantum Disease, Leishmaniasis, Visceral and Leishmaniasis, Cutaneous, sponsored by Meyer Children's Hospital IRCCS. Recruiting at 1 site in Italy. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2026-04-01.
Sponsored by Meyer Children's Hospital IRCCS · Observational
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.
68 studies on the registry are indexed under Leishmaniasis, Visceral; 7 are open to participants now.
This study's planned enrollment of 200 is below the median of 400 across 19 observational studies indexed under Leishmaniasis, Visceral.
Browse Leishmaniasis, Visceral studies →Meyer Children's Hospital IRCCS is the lead sponsor of 78 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Children and adolescents younger than 18 years of age with confirmed human leishmaniasis (visceral, cutaneous, or mucocutaneous) diagnosed according to WHO criteria and evaluated as inpatients or outpatients at participating Italian pediatric centers during the study period. Both retrospectively and prospectively identified patients may be included.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children younger than 18 years of age with confirmed visceral leishmaniasis, diagnosed according to World Health Organization criteria, evaluated at participating centers during the study period. Retrospective and prospective clinical, diagnostic, treatment, and outcome data will be collected.
Children younger than 18 years of age with confirmed cutaneous leishmaniasis, diagnosed according to World Health Organization criteria, evaluated at participating centers during the study period. Retrospective and prospective clinical, diagnostic, treatment, and outcome data will be collected, including assessment of different treatment approaches and healing outcomes.
Children younger than 18 years of age with confirmed mucocutaneous leishmaniasis, diagnosed according to World Health Organization criteria, evaluated at participating centers during the study period. Retrospective and prospective clinical, diagnostic, treatment, and outcome data will be collected.
Recovery rate according to therapeutic and diagnostic delay
Association between recovery rate and diagnostic and therapeutic delay, based on the time intervals from symptom onset to diagnosis and from diagnosis to treatment initiation.
Time frame: At diagnosis, 3, 6, 12 months from diagnosis
Death rate according to therapeutic and diagnostic delay
Association between death rate and diagnostic and therapeutic delay, based on the time intervals from symptom onset to diagnosis and from diagnosis to treatment initiation.
Time frame: At diagnosis, 3, 6, 12 months from diagnosis
Relapse rate according to therapeutic and diagnostic delay
Association between relapse rate and diagnostic and therapeutic delay, based on the time intervals from symptom onset to diagnosis and from diagnosis to treatment initiation.
Time frame: At diagnosis, 3, 6, 12 months from diagnosis
Severity of pediatric leishmaniasis
Severity of disease at presentation. For visceral leishmaniasis, severity will be assessed using duration of fever, hematologic abnormalities/cytopenias, duration of hospitalization, and occurrence of complications such as macrophage activation syndrome. For cutaneous and mucocutaneous leishmaniasis, severity will be assessed according to number and size of lesions and classification as simple or complicated forms.
Time frame: At diagnosis, 3, 6, 12 months from diagnosis
Risk factors for complicated forms of leishmaniasis
Association of age, area of origin, Leishmania species typing when available, and other clinical characteristics with the development of complicated visceral, cutaneous, or mucocutaneous leishmaniasis.
Time frame: From January 1, 2013 to June 30, 2026
Risk factors for relapse of leishmaniasis
Association of demographic, microbiologic, and clinical factors with relapse after initial clinical improvement.
Time frame: Baseline through 12 months of follow-up.
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Meyer Children's Hospital IRCCS