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New study aims to speed up leishmaniasis diagnosis in kids

NCT ID NCT07504757

Knowledge-focused Sponsor: Meyer Children's Hospital IRCCS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tracks 200 children in Italy with leishmaniasis, a parasitic infection that can affect the skin or internal organs. Researchers will look at how quickly the disease is diagnosed and treated, and how that affects recovery, relapse, and death rates. The goal is to identify delays and improve care for children with this condition.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help doctors diagnose and treat leishmaniasis in children faster, reducing complications and relapses.
What could go wrong
This is an observational study, not a treatment trial. It collects data but does not test a new drug or intervention, so direct patient benefits are not guaranteed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

Up to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cutaneous leishmaniasis mucocutaneous leishmaniasis visceral leishmaniasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Leishmania infantum disease Leishmaniasis, cutaneous Leishmaniasis, mucocutaneous Leishmaniasis, visceral

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AOU Meyer IRCCS

    RECRUITING

    Florence, Tuscany, 50139, Italy

More trials for these conditions

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