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临床试验/NCT05704218
NCT05704218尚未招募不适用

Hypersensitivity Pneumonitis of Domestic Origin: Investigation of the Microorganisms Involved and Improvement of Serological Diagnosis.

Centre Hospitalier Universitaire de Besancon0 个研究点目标入组 500 人开始时间: 2023年2月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
500
主要终点
measurement of mold sensitisation

研究概览

简要总结

Exposure to molds in dwellings is a public health problem. Diagnosis of hypersensitivity pneumonitis due to mold exposure at home (domestic HP) are increasing. To perform the serodiagnosis of domestic HP a cohort constitued of proven cases and exposed healthy controls are needed.

The HOME HP study aimed at obtaining a cohort of proven cases and exposed controls in order to be able to improve the serodiagnosis of domestic HP.

详细描述

Hypersensitivy pneumonitis (HP) are chronic respiratory diseases due to frequent exposure to high quantities of allergens (molds, bacteria, mycobacteria, avian proteins). In case of domestic HP, patients are exposed at home to molds due to flooding or poor ventilation.

The diagnosis of domestic HP includes detection of IgG towards molds. A prior study in 2005 allowed the determination of frequent allergenic molds isolated in homes in Bourgogne Franche Comte (study on 110 dwellings). However, no real cohort of proven cases versus controls is available. So, we are lacking validated thresholds. The HOME HP study is a prospective study that will include several centers of pneumology on France territory. The fungal contamination of dwellings occupied by patients suffering of interstitial disease (DIP), including suspicion of domestic HP, will be analyzed. The most frequently isolated molds will be then produced as antigens and will be tested in order to assess the sensitization of the included patients. The data of imagery, BALF cytology will allow to determine if patients are diagnosed with domestic HP or not. We will then obtain 2 groups of patients 1-proven domestic HP and 2-non domestic HP . Comparing the number of immunization arcs between the 2 groups will then be possible to validate appropriate thresholds for the serodiagnosis of domestic HP.

Domestic HP are rare diseases, so a high number of inclusions will be needed to obatin in 2 years about 25-30 proven cases. The HOME HP study is important to improve the serodiagnosis of domestic HP.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • exposure to mold at home
  • given consent
  • suspicion of doemstic HP
  • clinical signs of interstial pneumopathy

排除标准

  • immunocompromised patients
  • prior diagnosis of another HP form (avian, farm, bath tub etc..)
  • exposure to avian proteins

结局指标

主要结局

measurement of mold sensitisation

时间窗: 2 years

serology

measurement of mold presence in dwellings

时间窗: 2 years

dust collectors

testing of new fungal antigens

时间窗: 2 years

ELISA

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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