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临床试验/NCT06793111
NCT06793111招募中不适用

Visceral Leishmaniasis in Emilia-Romagna

IRCCS Azienda Ospedaliero-Universitaria di Bologna5 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020年4月21日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
5
主要终点
Epidemiology of Visceral Leishmaniasis (VL) cases in Emilia-Romagna

研究概览

简要总结

According to reports in the literature, from 2012 to date, there has been an increase in the number of diagnosed cases of autochthonous visceral Leishmania in the Province of Bologna.

In this context, it was decided to carry out a retrospective prospective observational study, which is essential to describe the epidemiology of LV in order to outline the scientific and rational bases necessary for the drafting of guidelines to standardise the diagnostic and therapeutic approach to this disease, in order to reduce the diagnostic delay and improve therapeutic results.

therapeutic outcome. In addition, epidemiological data will make it possible to identify possible new strategies to control the disease, which are essential for reducing its transmission.

详细描述

The term leishmaniasis refers to a heterogeneous group of anthropo-zoonoses caused by protozoa obligate intracellular protozoa, parasites of humans and various wild and domestic animals, belonging to the genus Leishmania. Despite being the cause of recurrent epidemic outbreaks with high rates of morbidity and mortality rates in certain geographical areas, the World Health Organisation (WHO) includes them among the Neglected Tropical Diseases. About 350 million people live in areas at risk for leishmaniasis with an estimated global prevalence of 12 million. The annual global incidence is estimated to be between 0.2 and 0.4 million cases for Visceral Leishmaniasis (LV) and between 0.7 and 1.2 million cases for Cutaneous Leishmaniasis Cutaneous. Leishmaniases are endemic infections in tropical, subtropical and temperate zones of all continents except Australia and Antarctica. More than 90% of LV cases are diagnosed in six countries: Bangladesh, Brazil, Ethiopia, India, South Sudan and Sudan, while the majority of LC cases are diagnosed in Afghanistan, Algeria, Brazil, Colombia, Iran, Pakistan, Peru, Saudi Arabia and Syria.

Leishmaniasis is also endemic in the Mediterranean Basin, including Italy, and in this area about 5% of global cases are found there, with a clear prevalence of visceral forms.

The incubation period varies from 4 to 10 months, but cases have been described in which incubation lasted for several years.

The onset is mostly gradual and insidious and the most characteristic clinical manifestations are asthenia fever (often initially framed as FUO), night sweats, anorexia and weight loss, splenomegaly, hepatomegaly and lymphadenomegaly. From a laboratory point of view, characteristic are anaemia, leucopenia and thrombocytopenia, more or less associated with each other, up to full-blown pancytopenia.

Dysprotidemia with hypergammaglobulinemia and hypoalbuminemia is typical. If not adequately treated, visceral leishmaniasis evolves towards a condition of cachexia and profound general decay and may prove fatal. A rare and serious complication of LV is the haemophagocytic syndrome. According to the 2010 WHO Leishmaniasis Control Report, a confirmed case of LV is defined as the association between typical clinical signs and symptoms (fever, splenomegaly, weight loss, etc.) and positivity of a parasitological examination (microscopy, RT-PCR or culture) in the presence or absence of positivity of serological investigations.

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
6 Years 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients of any age with microbiologically established diagnosis of LV.
  • Obtaining Informed Consent.

排除标准

  • not having obtained Informed Consent

结局指标

主要结局

Epidemiology of Visceral Leishmaniasis (VL) cases in Emilia-Romagna

时间窗: March 2020 - February 2025

In-depth description of the epidemiology of autochthonous visceral Leishmaniasis in the Emilia-Romagna region, focusing on the increase in diagnosed cases since 2012. The study will provide critical data for identifying trends in incidence, affected populations, and geographical hotspots, essential for guiding public health interventions. Measure: Number of diagnosed cases per year across participating centers. Unit of measure: Number of cases (n). Collection method: Review of medical records and epidemiological registries.

Socio-demographic and clinical characteristics of patients diagnosed with VL

时间窗: March 2020 - February 2025

Detailed analysis of the clinical features and presentations of diagnosed LV cases, including common symptoms such as fever, weight loss, splenomegaly, and laboratory findings like anemia and pancytopenia. This analysis will help establish a clearer clinical profile for early diagnosis and treatment strategies. Measure: Age, gender, comorbidities, geographic area of residence, known exposure mode. Unit of measure: Mean ± standard deviation (continuous variables), percentages (categorical variables). Collection method: clinical data collection.

次要结局

  • Monitoring of therapy tolerability(March 2020 - February 2025)
  • Diagnostic accuracy of methods used for VL identification(March 2020 - February 2025)
  • Evaluation of therapeutic outcomes of treated cases.(March 2020 - February 2025)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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