NCT05413720已完成不适用
Study of the Innate Immune Response to the Acute Phase of Human Leptospirosis - IMMUNOLEPTO
Centre Hospitalier Universitaire de la Réunion7 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年1月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 7
- 主要终点
- proportion of activated monocyte cells (CD14+CD16+ phenotype) within monocytes
研究概览
简要总结
The research hypothesis is based on a suspected strong involvement of the immune system in the genesis of serious manifestations of the disease (hepatitis, renal failure, thrombocytopenia, intra-alveolar hemorrhage). The question asked is that of the state of the immune system (quantitative and qualitative: activation markers, production of cytokines) evaluated by the study of circulating innate immune cells (monocytes, neutrophils, dendritic cells, lymphocytes, platelets).
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
- 4 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 4 years;
- •Weight ≥ 11 kg;
- •with ongoing symptoms compatible with a clinical diagnosis of leptospirosis.
- •AND having a diagnosis of leptospirosis confirmed according to standard care procedures: preferably by Polymerase Chain Reaction (PCR) (blood or urine) or, failing that, serology indicating a recent infection (positive Immunoglobulin M (IgM) or Microscopic Agglutination Test (MAT) technique with titer >1/400 for a pathogenic serogroup)
- •AND affiliated to a Social Security scheme
排除标准
- •Refusal of participation by the patient or his entourage if the patient is physically unable to give his opinion (coma, resuscitation, etc.).
- •Not affiliated with social security
- •Immunosuppression that may interfere with the interpretation of the results: chemotherapy in progress, immunosuppressants in progress for organ transplantation or autoimmune disease
- •Patient under legal protection (Guardianship, Curators)
结局指标
主要结局
proportion of activated monocyte cells (CD14+CD16+ phenotype) within monocytes
时间窗: at inclusion
次要结局
未报告次要终点
研究者
研究点 (7)
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