A Multicenter Study on Leishmaniasis in Children: Clinical and Epidemiological Characteristics and Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Recovery rate according to therapeutic and diagnostic delay
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients who do not meet the diagnostic criteria for confirmed human leishmaniasis
- •Lack of informed consent signed by parents or legal guardians, when required
结局指标
主要结局
Recovery rate according to therapeutic and diagnostic delay
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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.)
研究者
Elisabetta Venturini
Principal Investigator
Meyer Children's Hospital IRCCS