Actively Recruiting
A Multicenter Observational Study on Clinical and Epidemiological Characteristics and Outcomes of Leishmaniasis in Children
Led by Meyer Children's Hospital IRCCS · Updated on 2026-04-01
200
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Leishmaniasis is an infection caused by Leishmania parasites that can affect the skin or internal organs in children. Symptoms may resemble other conditions, leading to delayed diagnosis and treatment, which can worsen outcomes. Researchers are studying pediatric leishmaniasis in Italy to better understand its clinical and epidemiological characteristics, especially focusing on delays in diagnosis and treatment and the resulting patient outcomes. This observational study collects data from children diagnosed according to World Health Organization criteria, including retrospective and prospective information from multiple centers. The study involves children younger than 18 years diagnosed with visceral, cutaneous, or mucocutaneous leishmaniasis. Researchers gather clinical, diagnostic, treatment, and outcome data from medical records and follow-up visits during the first year after diagnosis. Different treatment approaches, particularly for cutaneous leishmaniasis, are assessed to compare healing and patient outcomes. The study includes patients evaluated from January 1, 2013, through June 30, 2031. Participants provide data at diagnosis and during follow-ups at 3, 6, and 12 months to measure recovery, relapse, death rates, and disease severity. Researchers also analyze risk factors for complicated disease forms and relapse over time. Data collection includes clinical assessments and treatment monitoring, aiming to improve understanding of pediatric leishmaniasis over the study period. The total observation period extends up to 18 years, covering both past and ongoing cases.
CONDITIONS
Brief Title
LEISH-PED: Study on Leishmaniasis in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Patients who do not meet the diagnostic criteria for confirmed human leishmaniasis
- Lack of informed consent signed by parents or legal guardians, when required
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At diagnosis
Participants undergo diagnostic assessments to confirm leishmaniasis and to evaluate disease severity.
1 visit (in-person)
Duration - 12 months from diagnosis
Participants are observed to assess recovery, relapse, death rates, and disease severity over time.
Visits at 3, 6, and 12 months from diagnosis
Trial Site Locations
Total: 1 location
1
AOU Meyer IRCCS
Florence, Tuscany, Italy, 50139
Actively Recruiting
Research Team
E
Elisabetta Venturini, MD,Phd
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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