Leptospirosis Registry - LeptoScope
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
Leptospirosis is a worldwide zoonotic diseases caused by pathogenic Leptospira spp. Human are accidental hosts, who acquired infections after exposition to animal urine, contaminated water or soil, infected tissue. Incidence of invasive leptospirosis disease causing acute kidney injury, acute respiratory distress syndrome (ARDS), myocarditis, hepatic dysfunction, hemorrhage and multi-organ failure, is globally increasing and there have been frequent outbreak situation throughout the world. Due to increasing outbreak situations and globally chances in species distributions, a worldwide surveillance in epidemiology and species distribution is urgently needed. The objective of the Leptospirosis Registry - LeptoScope is to overcome the lack knowledge on epidemiology, clinical course, prognostic factors and molecular characteristics for invasive leptospirosis disease.
详细描述
Leptospirosis is a worldwide zoonotic diseases caused by pathogenic Leptospira spp. Human are accidental hosts, who acquired infections after exposition to animal urine, contaminated water or soil, infected tissue. During bacteremia, Leptospira spp. may lead to invasive, deep-seated leptospirosis with infection of kidney, liver, heart and the central nervous system. Although cleaned from blood and most tissue by immune response, Leptospira spp. can persists and multiply in the tubuli of kidneys.
Incidence of invasive leptospirosis disease causing acute kidney injury, acute respiratory distress syndrome (ARDS), myocarditis, hepatic dysfunction, hemorrhage and multi-organ failure, is globally increasing and there have been frequent outbreak situation throughout the world. In Europe, invasive leptospirosis disease is less common than in the tropical and subtropical countries, however due to climate change incidence is rising, and there are worry-some trends concerning chancing species distribution and multiple outbreak situations throughout central Europe. Current treatment approaches consist of antibiotic therapies. Additionally, salvage supportive treatment approaches of critical ill patients are common in invasive leptospirosis disease requiring dialysis, hemodynamic support, mechanical ventilation or even extracorporeal membrane oxygenation (ECMO). Furthermore, invasive leptospirosis disease is associated with the development of chronic kidney disease.
Due to increasing outbreak situations and globally chances in species distributions, a worldwide surveillance in epidemiology and species distribution is urgently needed. Additionally, the examination of attributable mortality and costs analysis of invasive leptospirosis disease will need to be studied on a multinational basis and therefore LeptoScope will particularly use a matched case control design.
The objective of the Leptospirosis Registry - LeptoScope is to overcome the lack knowledge on epidemiology, clinical course, prognostic factors and molecular characteristics for invasive leptospirosis disease. Additionally, LeptoScope serves as a platform for monitoring complications of invasive leptospirosis disease and outbreak situations.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cultural, serological, molecular or histological evidence of invasive leptospirosis diseases
- •Clinical signs of disseminated leptospirosis disease without cultural, serological, molecular or histological evidence
- •Case controls: Matching procedures for controls: Particularly, case controls will be included at the same hospitals that conduced cases based on matching of demographics, underlying diseases and duration of hospitalization (i.e. one control per case, both in the same hospital).
排除标准
- •Colonization or other non-invasive infection
- •Cultural, serological, molecular or histological evidence without dissemination
结局指标
主要结局
Mortality
时间窗: up to 100 weeks
To describe global mortality due to invasive leptospirosis disease
Incidence
时间窗: up to 100 weeks
To describe the global incidence of invasive leptospirosis disease
次要结局
- Treatment efficacy of invasive leptospirosis disease in participants with treatment failure(at 90 days from diagnosis)
- Treatment efficacy of invasive leptospirosis disease in participants with stable disease(at 90 days from diagnosis)
- Occurrence of acute kidney injury according to KDIGO I, II, III(at 90 days from diagnosis)
- Occurrence of chronic kidney disease(up to 500 weeks)
- Resistance development(up to 100 weeks)
- Treatment efficacy of invasive leptospirosis disease in participants with complete responses(at 90 days from diagnosis)
- Need for renal replacement therapy(up to 500 weeks)
- Treatment efficacy of invasive leptospirosis disease in participants with partial responses(at 90 days from diagnosis)
研究者
Volker Burst
Principal Investigator
University of Cologne