跳至主要内容
临床试验/NCT07272915
NCT07272915已完成不适用

Performance Evaluation of the Fujifilm Wako Beta-D-glucan Technique and the Number of Determinations in the Diagnosis of Major Invasive Fungal Infections (IFI)

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2024年12月17日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
280
试验地点
1
主要终点
BDG level

研究概览

简要总结

Invasive fungal infections (IFI) are a major concern for immunocompromised or vulnerable patients. Associated mortality is significant and depends on the timeliness of diagnostic and therapeutic management. Consequently, biomarkers play a key role in therapeutic strategies compared to conventional phenotypic techniques, due to their shorter turnaround time. Beta-D-glucan (BDG) is a pan-fungal serum marker that enables the detection of invasive fungal infections (primarily candidiasis, aspergillosis, and pneumocystosis). This marker was initially introduced by CapeCod, and most studies are based on this test. More recently, the Wako test has been proposed and implemented in our center.

Our study aims to report our experience using the Wako test for BDG measurement, focusing on true and false positives.

The objective is to estimate the test performance, within the patient population, and the percentage of confirmed IFI diagnoses when at least two positive Wako test results are observed in the same patient within a consecutive 15-day period.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • BDG test in CHRU Nancy

排除标准

  • other hospitals

结局指标

主要结局

BDG level

时间窗: day 0

次要结局

未报告次要终点

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anne DEBOURGOGNE

PU-PH

Central Hospital, Nancy, France

研究点 (1)

Loading locations...

相似试验