NCT07504757 LEISH-PED: Study on Leishmaniasis in Children
| NCT ID | NCT07504757 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Meyer Children's Hospital IRCCS |
| Condition | Leishmania Infantum Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-01-30 |
| Primary Completion | 2031-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2025-01-30 with a primary completion date of 2031-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07504757 clinical trial?
This trial is open to participants of all sexes, up to 17 Years, studying Leishmania Infantum Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07504757 currently recruiting?
Yes, NCT07504757 is actively recruiting participants. Contact the research team at elisabetta.venturini@meyer.it for enrollment information.
Where is the NCT07504757 trial being conducted?
This trial is being conducted at Florence, Italy.
Who is sponsoring the NCT07504757 clinical trial?
NCT07504757 is sponsored by Meyer Children's Hospital IRCCS. The trial plans to enroll 200 participants.