Trials / Recruiting
RecruitingNCT07504757
LEISH-PED: Study on Leishmaniasis in Children
A Multicenter Study on Leishmaniasis in Children: Clinical and Epidemiological Characteristics and Outcomes
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 200 (estimated)
- Sponsor
- Meyer Children's Hospital IRCCS · Academic / Other
- Sex
- All
- Age
- 17 Years
- Healthy volunteers
- Not accepted
Summary
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
- Leishmania Infantum Disease
- Leishmaniasis, Visceral
- Leishmaniasis, Cutaneous
- Leishmaniasis, Mucocutaneous
Timeline
- Start date
- 2025-01-30
- Primary completion
- 2031-06-30
- Completion
- 2031-12-30
- First posted
- 2026-04-01
- Last updated
- 2026-04-01
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT07504757. Inclusion in this directory is not an endorsement.