Clinical Evaluation of Long-term Sequelae in Patients With Severe Plasmodium Falciparum Malaria
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- frequency of long-term sequelae of severe malaria
研究概览
简要总结
Malaria, endemic in 85 countries, remains a major concern. By 2022, there will be 249 million cases and 608,000 deaths, 94% of them in Africa. In France, 4995 cases of imported malaria were reported in 2021, with 15% of severe forms and a fatality rate of 2.5%. Long-term sequelae, such as kidney failure and neurological disorders, are well documented in children, but few studies have focused on adults.
the main objective is to describe and estimate the frequency of long-term sequelae of severe imported malaria treated at our centre.
the aim is to compare long-term neurological sequelae between neuromalaria and severe malaria without neurological disorders. In addition, the investigator aim to identify the clinical, radiological and biological factors associated with sequelae in order to improve post-hospitalisation follow-up. Finally, the investigator aim to describe acute complications arising at diagnosis and during hospitalisation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female over 18 years of age
- •Have been diagnosed with severe malaria according to WHO criteria and have been treated between 1/1/2018 and 321/12/2024 at the AP-HM
- •Have been treated with Artesunate IV (MALACEF®) (at least one dose)
- •Patient who has received information about the study and has not expressed opposition
- •Patient benefiting or entitled to benefit from a social security scheme
排除标准
- •Patients with advanced neurodegenerative pathology pre-existing the malaria attack
- •Subjects covered by articles L1121-5 to 1121-8 of the Public Health Code (minor patients, patients of legal age under guardianship, curatorship or safeguard of justice, patients deprived of their liberty, pregnant or breast-feeding women),
- •Persons who do not understand French
研究组 & 干预措施
malaria patient
干预措施: Questionnaire (Other)
结局指标
主要结局
frequency of long-term sequelae of severe malaria
时间窗: 12 months
Assessment of after-effects one year after diagnosis
次要结局
未报告次要终点