Clinical trial NCT01902030: Evaluation of Performance of An Aspergillus PCR in Tissue and Pleural Effusion Samples of Immunocompromised Patients
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aspergillosis
Immunosuppression
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2013-07-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Immunocompromised individuals with suspicion of harbouring an invasive fungal infection

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.


Eligibility criteria: 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

Primary outcomes:
measure: Calculation of sensitivity, Specificity, positive predictive value, negative predictive value and diagnostic odds ratio
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Cologne University Hospital
city: Duesseldorf
country: Germany
facility: Duesseldorf University Hospital
city: Eschweiler
country: Germany
facility: Eschweiler General Hospital
city: Frankfurt (Oder)
country: Germany
facility: Frankfurt (Oder) General Hospital
city: Freiburg
country: Germany
facility: Freiburg University Hospital
city: Halle (Saale)
country: Germany
facility: Halle University Hospital
city: Heidelberg
country: Germany
facility: Thoraxklinik at Heidelberg University Hospital
city: Herne
country: Germany
facility: Marienhospital Herne
city: Mannheim
country: Germany
facility: Mannheim University Hospital
city: Recklinghausen
country: Germany
facility: Prosper Hospital Recklinghausen
city: Wiesbaden
country: Germany
facility: Wiesbaden Bone Marrow transplantation center
city: Wuerzburg
country: Germany
facility: Wuerzburg University Hospital
Study officials:
affiliation: Heidelberg University
name: Dieter Buchheidt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spiess B, Seifarth W, Hummel M, Frank O, Fabarius A, Zheng C, Morz 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. doi: 10.1128/JCM.00942-07. Epub 2007 Aug 22.
citation: Boch T, Reinwald M, Postina P, Cornely OA, Vehreschild JJ, Heussel CP, Heinz WJ, Hoenigl M, Eigl S, Lehrnbecher T, Hahn J, Claus B, Lauten M, Egerer G, Muller MC, Will S, Merker N, Hofmann WK, Buchheidt D, Spiess B. Identification of invasive fungal diseases in immunocompromised patients by combining an Aspergillus specific PCR with a multifungal DNA-microarray from primary clinical samples. Mycoses. 2015 Dec;58(12):735-45. doi: 10.1111/myc.12424. Epub 2015 Oct 26.