跳至主要内容
临床试验/NCT05413720
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

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

发起方
Centre Hospitalier Universitaire de la Réunion
申办方类型
Other
责任方
Sponsor

研究点 (7)

Loading locations...

相似试验

Study of the Innate Immune Response to the Acute... | 临床试验