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

NCT ID: NCT01902030

Last Updated: 2020-04-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2020-12-31

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.

Conditions

Aspergillosis; Immunosuppression

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Proven/Probable IA Patients

Case Population

No interventions assigned to this group

possible/No IA Patients

Control population

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heidelberg University

OTHER

Sponsor Role: lead

Responsible Party

Dieter Buchheidt

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dieter Buchheidt, MD

Role: PRINCIPAL_INVESTIGATOR

Heidelberg University

Locations

Cologne University Hospital

Cologne, , Germany

Duesseldorf University Hospital

Düsseldorf, , Germany

Eschweiler General Hospital

Eschweiler, , Germany

Frankfurt (Oder) General Hospital

Frankfurt (Oder), , Germany

Freiburg University Hospital

Freiburg im Breisgau, , Germany

Halle University Hospital

Halle, , 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

Würzburg, , Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 17715373 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26497302 (View on PubMed)

Other Identifiers

ASP PCR IA TISSUE-EFFUSION

Identifier Type: -

Identifier Source: org_study_id