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

• Conditions: Immunosuppression; Aspergillosis

• Registration Number: NCT01902030
• Lead Sponsor: Heidelberg University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-27
• Study First Submitted QC: 2013-07-15
• Study First Posted: 2013-07-17
• Study Start: 2014-01
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-17
• Last Update Posted: 2020-04-20
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Calculation of sensitivity, Specificity, positive predictive value, negative predictive value and diagnostic odds ratio	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

Trial Locations

Locations (12)

Eschweiler General Hospital; 🇩🇪 Eschweiler, Germany

Duesseldorf University Hospital; 🇩🇪 Duesseldorf, Germany

Frankfurt (Oder) General Hospital; 🇩🇪 Frankfurt (Oder), Germany

Mannheim University Hospital; 🇩🇪 Mannheim, Germany

Thoraxklinik at Heidelberg University Hospital; 🇩🇪 Heidelberg, Germany

Marienhospital Herne; 🇩🇪 Herne, Germany

Wiesbaden Bone Marrow transplantation center; 🇩🇪 Wiesbaden, Germany

Cologne University Hospital; 🇩🇪 Cologne, Germany

Freiburg University Hospital; 🇩🇪 Freiburg, Germany

Halle University Hospital; 🇩🇪 Halle (Saale), Germany

Prosper Hospital Recklinghausen; 🇩🇪 Recklinghausen, Germany

Wuerzburg University Hospital; 🇩🇪 Wuerzburg, Germany