NCT01902030

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

12 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2013

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 17, 2013

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

April 20, 2020

Status Verified

April 1, 2020

Enrollment Period

6.9 years

First QC Date

June 27, 2013

Last Update Submit

April 17, 2020

Conditions

AspergillosisImmunosuppression

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Proven/Probable IA Patients

Case Population

possible/No IA Patients

Control population

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* Immunocompromised individuals with suspicion of harbouring an invasive fungal infection

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Cologne University Hospital

Cologne, 50937, Germany

Location

Duesseldorf University Hospital

Düsseldorf, 40225, Germany

Location

Eschweiler General Hospital

Eschweiler, 52249, Germany

Location

Frankfurt (Oder) General Hospital

Frankfurt (Oder), 15236, Germany

Location

Freiburg University Hospital

Freiburg im Breisgau, 79106, Germany

Location

Halle University Hospital

Halle, Germany

Location

Thoraxklinik at Heidelberg University Hospital

Heidelberg, 68167, Germany

Location

Marienhospital Herne

Herne, 44625, Germany

Location

Mannheim University Hospital

Mannheim, 68167, Germany

Location

Prosper Hospital Recklinghausen

Recklinghausen, Germany

Location

Wiesbaden Bone Marrow transplantation center

Wiesbaden, Germany

Location

Wuerzburg University Hospital

Würzburg, 97080, Germany

Location

Related Publications (2)

  • 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.

    PMID: 17715373BACKGROUND

  • 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.

    PMID: 26497302DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Fungal DNA, no human DNA

MeSH Terms

Conditions

Aspergillosis

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfections

Study Officials

  • Dieter Buchheidt, MD

    Heidelberg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 27, 2013

First Posted

July 17, 2013

Study Start

January 1, 2014

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

April 20, 2020

Record last verified: 2020-04

Locations

DE(12)