Diagnostic Study of Performance of an Aspergillus Specific Polymerase Chain Reaction in Tissue and Pleural Effusion Samples of Immunocompromised Patients for the Diagnosis of Invasive Aspergillosis
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 12
- 主要终点
- Calculation of sensitivity, Specificity, positive predictive value, negative predictive value and diagnostic odds ratio
研究概览
简要总结
Although being a frequent and lethal complication in patients (pts) with hematologic malignancies, diagnosing invasive aspergillosis (IA) still remains a difficult issue as culture-based methods show low sensitivity especially under the current clinical practice of antifungal prophylaxis or rapid antifungal therapy. In certain clinical settings, performing biopsies for identification of the underlying infectious organism becomes important. However, as culture-based methods only yield results in a minority of patients, using non-culture-based methods like Aspergillus specific polymerase chain reaction (PCR) for detection of IA directly in clinical specimens is becoming increasingly important and might help to characterize the causative pathogen.
Therefore the performance of an established Aspergillus-specific nested PCR in biopsies, re-section material or pleural effusions is evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Immunocompromised individuals with suspicion of harbouring an invasive fungal infection
- •Definition by 2008 EORTC/MSG Criteria (de Pauw CID 2008)
排除标准
- 未提供
结局指标
主要结局
Calculation of sensitivity, Specificity, positive predictive value, negative predictive value and diagnostic odds ratio
时间窗: 3 months
Evaluation of Sensitivity, Specificity, positive predictive value, negative predictive value and diagnostic odds ratio of aspergillus specific PCR in tissue and effusion samples by comparing the population with proven / probable invasive aspergillosis with patients suffering from No IA according to recent EORTC/MSG criteria of PCR in Biopsies/Effusion samples of Patients
次要结局
未报告次要终点
研究者
Dieter Buchheidt
MD
Heidelberg University
