ECMM Candida Registry - CandiReg
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
The objective of the European Confederation of Medical Mycology - ECMM Candida Registry (CandiReg) is to overcome the lack of knowledge on epidemiology, clinical course, and molecular characteristics of invasive infections due to invasive Candida infections and to function as a platform for future studies and in case of outbreaks.
详细描述
The specific objectives are:
To describe the global incidence of invasive Candida infection To monitor trends globally and locally over time To define patient risk groups To assess antifungal resistance among Candida spp. causing invasive diseases worldwide To assess attributable mortality of invasive Candida infection To assess incremental costs associated with invasive Candida infection
To describe the clinical pattern of disease To document diagnostic procedures performed for confirmation of diagnosis To describe first-line and salvage treatment regimens applied, guideline adherence, their efficacy and impact on patient survival To inform consensus guidelines To develop clinical screening and diagnostic procedures
Set up of a collection of isolates with molecular characterization and evaluation of resistance genes
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cultural, histopathological, antigen or DNA evidence of invasive fungal infection with Candida species.
- •Hepatosplenic candidiasis with signs of disseminated Candida infection without culture, histological or microscopic evidence
- •Case control
- •Matching procedure for controls:
- •In part, controls will be included at the same hospitals that include cases (i.e. each one control per case, both in the same hospital).
- •Controls will be matched by demographics, underlying diseases and risk factors as well as duration of hospitalization
排除标准
- •Colonization or other non-invasive infection, including superficial skin infections, candiduria without dissemination or Candida spp. in stool.
结局指标
主要结局
Mortality
时间窗: up to 100 weeks
To describe the global mortality of invasive Candida infection
Molecular characteristics of Candida auris
时间窗: At 90 Days from diagnosis
To describe the molecular characteristics of Candida auris
Resistance development
时间窗: up to 100 weeks
To describe the resistance development of Candida auris
Susceptibility testing
时间窗: At 90 Days from diagnosis
To describe the susceptibility of Candida auris
Incidence
时间窗: up to 100 weeks
To describe the global incidence of invasive Candida infection
次要结局
- Treatment efficacy of invasive candida infections(At 90 Days from diagnosis)
研究者
Oliver Cornely, MD
Prof. Dr. med.
University of Cologne