跳至主要内容
临床试验/NCT06069505
NCT06069505招募中不适用

Detection of Azole Resistance Inducing Mutations on DNA Extracted Directly From Serum or Plasma of Immunocompromised Patients With an Invasive Aspergillus Infection Azole Resistance PCR Optimalization-study

Bart Rijnders1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2017年7月1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
300
试验地点
1
主要终点
Determination of best PCR cycle threshold

研究概览

简要总结

Invasive aspergillosis (IA) is the most common mould infection in immunocompromised patients with haematological disease. Voriconazole, a triazole, improves overall survival of patients with an IA and is the mainstay of therapy. Resistance of A. Fumigatus emerged as an important clinical problem and infections with azole resistant Aspergillus have a high mortality. Nowhere in the world, azole resistance is more prevalent than in the Netherlands. Rapid detection of resistance is key to improve the patient's outcome but fungal cultures take time and are often negative. The investigators aim to detect azole resistance associated mutations in fungal DNA extracted directly from serum or plasma to accelerate diagnosis and improve outcome of patients infected with azole resistant A. fumigatus.

研究设计

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

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

  • 18 years or older.
  • Lung CT shows lesions that fulfil the EORTC/MSG radiological criteria of possible invasive fungal infection.
  • A bronchoalveolar lavage is planned or has been performed <48hrs earlier

排除标准

  • Patients unable or unwilling to provide consent

结局指标

主要结局

Determination of best PCR cycle threshold

时间窗: 1 week

Extraction medium (serum versus plasma) and extraction volume (1, 3 or 10 ml) that results in best sensitivity and specificity will be determined

Performance of two different media for the PCR test

时间窗: 1 week

Extraction medium (serum versus plasma) and extraction volume (1, 3 or 10 ml) that results in best sensitivity and specificity will be determined

Performance of two different PCR test

时间窗: 1 week

The sensitivity and specificity will be determined of the different PCR's tested including the commercially available AsperGenius (Pathonostics, Maastricht) and the in-house PCR. For this purpose a patients diagnosed with proven or probable IPA according to the EORTC/MSG definition will be used as the gold standard.

次要结局

未报告次要终点

研究者

发起方
Bart Rijnders
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Bart Rijnders

Clinical Professor in Infectious Diseases

Erasmus Medical Center

研究点 (1)

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