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

Immunosuppression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01902030
• Other study ID #: ASP PCR IA TISSUE-EFFUSION
• Status: Enrolling by invitation
• Start date: January 2014
• Est. completion date: December 2020

Study information

• Verified date: April 2020
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aspergillosis
• Immunosuppression
• Pleural Effusion

Locations

Country	Name	City	State
Germany	Cologne University Hospital	Cologne
Germany	Duesseldorf University Hospital	Duesseldorf
Germany	Eschweiler General Hospital	Eschweiler
Germany	Frankfurt (Oder) General Hospital	Frankfurt (Oder)
Germany	Freiburg University Hospital	Freiburg
Germany	Halle University Hospital	Halle (Saale)
Germany	Thoraxklinik at Heidelberg University Hospital	Heidelberg
Germany	Marienhospital Herne	Herne
Germany	Mannheim University Hospital	Mannheim
Germany	Prosper Hospital Recklinghausen	Recklinghausen
Germany	Wiesbaden Bone Marrow transplantation center	Wiesbaden
Germany	Wuerzburg University Hospital	Wuerzburg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Spiess B, Seifarth W, Hummel M, Frank O, Fabarius A, Zheng C, Mörz H, Hehlmann R, Buchheidt D. DNA microarray-based detection and identification of fungal pathogens in clinical samples from neutropenic patients. J Clin Microbiol. 2007 Nov;45(11):3743-53. Epub 2007 Aug 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calculation of sensitivity, Specificity, positive predictive value, negative predictive value and diagnostic odds ratio	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	3 months