跳至主要内容
临床试验/NCT01695499
NCT01695499Unknown不适用

Open, Prospective, Multicenter Trial to Evaluate the Clinical Significance of Combined Serological (Galactomannan ELISA, Beta D Glucan Assay) and Molecular (Nested Aspergillus PCR Assay, Real-time qPCR Assay, Multifungal DNA Microarray) Diagnostic Assays to Detect and Characterize Fungal Pathogens in Bronchoalveolar Lavage (BAL)and Blood Samples of Intensive Care Unit Patients With Pulmonary Infiltrates

Heidelberg University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2012年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Diagnostic accuracy of combined biomarker testing in BAL fluid in relation to diagnostic certainty

研究概览

简要总结

The aim of this project is therefore to explore on the clinical significance of analyzing surrogate markers combined with conventional diagnostics in the ICU setting. BAL, blood and biopsy samples will be subjected to a combined analysis of GM, BDG, Aspergillus specific PCR assays in addition to conventional diagnostics (Microscopy, Culture,Histology) for ICU pts with pulmonary infiltrates.

As GM and BDG are not species-specific, three established and repeatedly published species specific PCR-based assays (nested PCR, real time PCR assay, multifungal DNA Array)developed by our group will be investigated in combination with the serological tests in a multicenter prospective clinical diagnostic trial.

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • underlying conditions (see above)
  • being on mechanical ventilation
  • lung infiltrates

排除标准

  • immunocompetent patients (not fulfilling the criteria above)

结局指标

主要结局

Diagnostic accuracy of combined biomarker testing in BAL fluid in relation to diagnostic certainty

时间窗: 6 weeks

Evaluation of diagnostic accuracy of the combined biomarker approach

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dieter Buchheidt

Professor Dr. Dieter Buchheidt

Heidelberg University

研究点 (1)

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