Evaluation of Performance of An Aspergillus PCR in Tissue and Pleural Effusion Samples of Immunocompromised Patients

Heidelberg University

Status: Unknown

Conditions: Aspergillosis; Immunosuppression

Study type: Observational

Funder types: Other

Identifiers

NCT01902030

ASP PCR IA TISSUE-EFFUSION

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Immunocompromised individuals with suspicion of harbouring an invasive fungal infection
• Definition by 2008 EORTC/MSG Criteria (de Pauw CID 2008)

Exclusion criteria

• none

Trial design

100 participants in 2 patient groups

Proven/Probable IA Patients

Description:

Case Population

possible/No IA Patients

Description:

Control population