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临床试验/NCT06532227
NCT06532227尚未招募不适用

AspergillusOne-Health: Deciphering Azole Resistance in Aspergillus Fungi Using a One Health Approach

Nantes University Hospital1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2026年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,000
试验地点
1
主要终点
Environmental risk factors

研究概览

简要总结

During a two year prospective study onpatients from department's hospitals and centralized by the pneumology department Nantes CH,all respiratory clinical samples will be cultivated for Aspergillus isolation (2900Aspergillusisolates) as standard care. The azole susceptibility pattern of isolates will be determined to itraconazole, voriconazole by subculture on azole- enriched medium at 35°c as primary screen and resistance confirmed by EUCAST Reference metho.In parallel, the relevance of detecting resistance (TR34 and TR46) directly in culture-negative BAL respiratory samples by a qPCR method will be studied in an attempt to reach a greater exhaustiveness of the resistance phenomeno. In case of azole-resistant isolate,patient data such as the underlying disease,date and site of Aspergillus isolation,disease classification,previous azole drug exposure,and home and work geographic allocation,occupation of the patient will be collecte. For all other aspergillus occurrences, underlying disease, previous azole drug exposure,home and work location of the patient will be collected in an attempt to identify risk factor.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Other

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient over 18 years of age
  • Patient who has given his or her consent to participate in the study
  • Patient affiliated to a social security scheme
  • Patient with a respiratory sample taken between 2020 and 2023 for the retrospective cohort and from 2024 for the prospective cohort in which Aspergillus has been isolated
  • Patients living in the Loire Atlantique and Vendée regions

排除标准

  • Patient under guardianship or legal protection
  • Patient of no fixed adress

结局指标

主要结局

Environmental risk factors

时间窗: 24 months

Identify the "macro" environmental risk factors for acquiring azole-resistant aspergillus.

次要结局

  • Risk factors(48 months)
  • Describe the management and evolution of resistant(48 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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