NCT04034550进行中（未招募）不适用
Cohort of Hospitalized Patients Suspected of Leptospirosis
Institut National de la Santé Et de la Recherche Médicale, France8 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年1月6日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 8
- 主要终点
- disease severity
研究概览
简要总结
COLEPT is a prospective interventional study that intends to better inform about leptospirosis, a neglected zoonotic infectious disease. During prospective follow-up of hospitalized acute leptospirosis cases, the participants will be assessed during 1 year for epidemiological, clinical, bacteriological and immunological data. Main intervention consists in blood sampling and biological bank constitution.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •clinico-biological manifestations compatible with acute leptospirosis OR proven leptospirosis with serological testing or PCR
- •onset of symptoms within 21 days
- •participant benefits of health insurance
排除标准
- •participant's refusal, or refusal from his relatives in case of major incapacity of the eligible participant precluding expression of his will (coma, stay in intensive care unit))
研究组 & 干预措施
hospitalized patients diagnosed with leptospirosis
Experimental
hospitalized patients diagnosed with leptospirosis: 12 months of follow up with biological samples and data collection
干预措施: Blood and urine sampling and blood banking (Other)
结局指标
主要结局
disease severity
时间窗: 0 to 21 days after onset of symptoms
Rate of death or severe organ insuffisiency
次要结局
未报告次要终点
研究者
研究点 (8)
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