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临床试验/NCT04937751
NCT04937751招募中不适用

Multicenter Study on Invasive Fusariosis : Looking for Markers of Infection and Resistance

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年7月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
150
试验地点
1
主要终点
proportions of different fungal species in positive fungal cultures in patients with invasive fungal infection (IFI) or fungal keratitis

研究概览

简要总结

In recent decades, invasive fusarioses have been emerging fungal pathologies with high mortality. The prognosis depends on the speed of the diagnosis, but currently biological diagnosis is mainly based on fungal culture, no specific biomarker for this microorganism is available in current clinical practice. The genus Fusarium also shows reduced sensitivity to antifungals commonly used and recommended in clinical practice, such as voriconazole or amphotericin B.

The main objective of this study is to describe the proportions of different fungal species in positive fungal cultures in patients with invasive fungal infection (IFI) or fungal keratitis. The secondary objectives are the description of the dosage of galactomannans, beta (1,3) -D-glucans and the rate of detection of DNA circulating in case / control groups for the 2 clinical forms studied. In patients with evidence of Fusarium wilt, the study will describe the distribution of the different minimum inhibitory concentrations (MIC) depending on whether or not different antifungals are taken, the vital status at 3 months, and the response or not to treatment. Finally, the presence of genetic markers will be described according to the groups of MIC values.

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

  • Suspicion of invasive fungal infection involving the performance of a blood culture or a skin biopsy or diagnosis of keratitis involving the taking of a cornea sample
  • Fungal culture carried out on this sample
  • Person having been informed of the research and not having opposed the use of their data

排除标准

  • Clinical diagnosis of superficial fusarium wilt (onychomycosis, etc.)

结局指标

主要结局

proportions of different fungal species in positive fungal cultures in patients with invasive fungal infection (IFI) or fungal keratitis

时间窗: 2021-2026

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

Principal investigator

Central Hospital, Nancy, France

研究点 (1)

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