跳至主要内容
临床试验/NCT05720728
NCT05720728已完成不适用

Research of New Serological Markers for the Diagnosis and Monitoring of Candidaemia in Hospitalized Patients

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年5月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
levels of antibodies

研究概览

简要总结

Bloodstream infections due to Candida spp remain a serious medical challenge because of their high incidence and poor outcome. Diagnosis and monitoring of patients are still problematic, hindering efficient clinical management of the disease. The invastigators propose here to perform a retrospective study in a clinically well-characterized candidemic patient, with the goal of recognizing host immunological factors and virulence-associated fungal molecules relevant in the onset and evolution of infection. The researchers' ultimate goal is to identify new diagnostic and/or prognostic benchmarks useful in clinical settings. By combining serologic and immunologic expertise with clinical expertise, the research team has real potential to generate new markers of host pathogenesis and immune response in candidemia and to inform prospective clinical trials to control this terrible disease

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • patients hospitalized
  • one or more positive blood cultures for Candida spp,
  • positive beta-glucanemia
  • the presence of at least one clinical symptom of infection will be considered cases of candidemia.

排除标准

  • age less than 18 years
  • state of immunosuppression
  • incompleteness of clinical data
  • unavailability of serum samples in sufficient quantities for analysis and in good condition.

结局指标

主要结局

levels of antibodies

时间窗: 1 year

i) presence and levels of antibodies directed towards beta-glucans and Candida virulence proteins. ii) presence and levels of circulating Candida virulence proteins. iii) presence and levels of soluble mediators of innate immunity and inflammation No genetic analysis will be performed.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验