LEISH-PED: Study on Leishmaniasis in Children

NCT07504757 | Recruiting

• 1 other identifier: LEISH-PED
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Leishmania Infantum Disease; Leishmaniasis, Visceral; Leishmaniasis, Cutaneous; Leishmaniasis, Mucocutaneous

Keywords

Pediatric leishmaniasis; Visceral leishmaniasis; Cutaneous leishmaniasis; Mucocutaneous leishmaniasis; Children; Italy; Diagnostic delay; Leishmania infantum

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  At diagnosis, 3, 6, 12 months from diagnosis

Secondary Outcomes (2)

• Risk factors for complicated forms of leishmaniasis

  From January 1, 2013 to June 30, 2026

• Risk factors for relapse of leishmaniasis

  Baseline through 12 months of follow-up.

Study Arms (3)

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.

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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 may not qualify if:

• Patients who do not meet the diagnostic criteria for confirmed human leishmaniasis
• Lack of informed consent signed by parents or legal guardians, when required

Sponsors & Collaborators

• Meyer Children's Hospital IRCCS: lead

Study Sites (1)

AOU Meyer IRCCS

Florence, Tuscany, 50139, Italy

RECRUITING

MeSH Terms

Conditions

Leishmaniasis, Visceral; Leishmaniasis, Cutaneous; Leishmaniasis, Mucocutaneous

Condition Hierarchy (Ancestors)

Leishmaniasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases; Skin Diseases, Parasitic; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Elisabetta Venturini, MD,Phd

CONTACT

+39 3490920901; elisabetta.venturini@meyer.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 1, 2026
• Study Start: January 30, 2025
• Primary Completion (Estimated): June 30, 2031
• Study Completion (Estimated): December 30, 2031
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

IT (1)