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NCT Number: NCT07504757

LEISH-PED: Study on Leishmaniasis in Children

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.

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Key information

Conditions

Leishmania Infantum Disease Euglenozoa Infections Infections Leishmaniasis Leishmaniasis, Cutaneous Leishmaniasis, Mucocutaneous Leishmaniasis, Visceral Parasitic Diseases Protozoan Infections Skin Diseases Skin Diseases, Infectious Skin Diseases, Parasitic Skin and Connective Tissue Diseases Vector Borne Diseases

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

AOU Meyer IRCCS

Florence, Tuscany, 50139, Italy

Location status: Recruiting

Location contact

Elisabetta Venturini, MD, PhD

CONTACT

[email protected]

+39 3490920901

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Recovery rate according to therapeutic and diagnostic delay

    Time frame: At diagnosis, 3, 6, 12 months from diagnosis

    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.

  2. Death rate according to therapeutic and diagnostic delay

    Time frame: At diagnosis, 3, 6, 12 months from diagnosis

    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.

  3. Relapse rate according to therapeutic and diagnostic delay

    Time frame: At diagnosis, 3, 6, 12 months from diagnosis

    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.

  4. Severity of pediatric leishmaniasis

    Time frame: At diagnosis, 3, 6, 12 months from diagnosis

    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.

Secondary outcomes

  1. Risk factors for complicated forms of leishmaniasis

    Time frame: From January 1, 2013 to June 30, 2026

    Association of age, area of origin, Leishmania species typing when available, and other clinical characteristics with the development of complicated visceral, cutaneous, or mucocutaneous leishmaniasis.

  2. Risk factors for relapse of leishmaniasis

    Time frame: Baseline through 12 months of follow-up.

    Association of demographic, microbiologic, and clinical factors with relapse after initial clinical improvement.

Study contacts

Contact information is provided by the study sponsor or research team.

Elisabetta Venturini, MD,Phd

CONTACT

[email protected]

+39 3490920901

Sponsors and collaborators

Lead sponsor

Meyer Children's Hospital IRCCS

Other

Registry information

Official study title

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

Acronym: LEISH-PED

Important dates

Study start
2025
Primary completion
2031
Study completion
2031
First posted
Apr 1, 2026
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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