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
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
- 否
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
Dieter Buchheidt
Professor Dr. Dieter Buchheidt
Heidelberg University
