Leishmania Infantum DiseaseLEISH-PEDNCT07504757
LEISH-PED: Study on Leishmaniasis in Children
An observational study of Leishmania Infantum Disease and Leishmaniasis, Visceral, run by Meyer Children's Hospital IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Leishmania Infantum Disease, Leishmaniasis, Visceral, Leishmaniasis, Cutaneous
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 30 Jan 2025to 30 Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- Patients who do not meet the diagnostic criteria for confirmed human leishmaniasis
- Lack of informed consent signed by parents or legal guardians, when required
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
AOU Meyer IRCCS
Florence, Tuscany, 50139
Elisabetta Venturini, MD, PhD, +39 3490920901, elisabetta.venturini@meyer.it
About this study
Official title: A Multicenter Study on Leishmaniasis in Children: Clinical and Epidemiological Characteristics and Outcomes
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
- Medical subject headings
- Leishmaniasis, Visceral, Leishmaniasis, Cutaneous, Leishmaniasis, Mucocutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At diagnosis, 3, 6, 12 months from diagnosis
Secondary outcomes (2)
Risk factors for complicated forms of leishmaniasis
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.
Measured: From January 1, 2013 to June 30, 2026
Risk factors for relapse of leishmaniasis
Association of demographic, microbiologic, and clinical factors with relapse after initial clinical improvement.
Measured: Baseline through 12 months of follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start30 Jan 2025
- Primary completion30 Jun 2031 (estimated)
- Study completion30 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leishmania Infantum DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meyer Children's Hospital IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisabetta Venturini, Meyer Children's Hospital IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07504757
- Sponsor's protocol ID
- LEISH-PED
- Acronym
- LEISH-PED
- Status last verified
- Mar 2026
- First submitted
- 26 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study on Leishmaniasis in Children: Clinical and Epidemiological Characteristics and Outcomes
- ClinicalTrials.gov ID
- NCT07504757
- Acronym / sponsor ID
- LEISH-PED / LEISH-PED
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Meyer Children's Hospital IRCCSUniversity, hospital or other
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 30 Jun 2031 (estimated)
- Study completion
- 30 Dec 2031 (estimated)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patients who do not meet the diagnostic criteria for confirmed human leishmaniasis
- Lack of informed consent signed by parents or legal guardians, when required
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
2 secondary outcomes
Risk factors for complicated forms of leishmaniasis
Time frame: From January 1, 2013 to June 30, 2026
Risk factors for relapse of leishmaniasis
Time frame: Baseline through 12 months of follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leishmania Infantum Disease and Leishmaniasis, Visceral, run by Meyer Children's Hospital IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elisabetta Venturini, MD,Phd (+39 3490920901, elisabetta.venturini@meyer.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery rate according to therapeutic and diagnostic delay (time frame: At diagnosis, 3, 6, 12 months from diagnosis). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026; AzTrials last refreshed its copy on 31 Oct 2026.