跳至主要内容
临床试验/NCT01902030
NCT01902030Unknown不适用

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

Heidelberg University12 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年1月最近更新:
适应症

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

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

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

Dieter Buchheidt

MD

Heidelberg University

研究点 (12)

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