Leishmaniasis Clinical Trials

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A Multicenter Study on Leishmaniasis in Children: Clinical and Epidemiological Characteristics and Outcomes

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Maximum Age: 17
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
AOU Meyer IRCCS
RECRUITING
Florence
Contact Information
Primary
Elisabetta Venturini, MD,Phd
elisabetta.venturini@meyer.it
+39 3490920901
Time Frame
Start Date: 2025-01-30
Estimated Completion Date: 2031-12-30
Participants
Target number of participants: 200
Treatments
Visceral Leishmaniasis
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.
Cutaneous Leishmaniasis
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.
Mucocutaneous Leishmaniasis
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.
Related Therapeutic Areas
Sponsors
Leads: Meyer Children's Hospital IRCCS

This content was sourced from clinicaltrials.gov