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

Sponsor
Heidelberg University (Other)
Overall Status
Unknown status
CT.gov ID
NCT01902030
Collaborator
(none)
100
Enrollment
12
Locations
83
Duration (Months)
8.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    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 Start Date :
    Jan 1, 2014
    Anticipated Primary Completion Date :
    Dec 1, 2020
    Anticipated Study Completion Date :
    Dec 1, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Proven/Probable IA Patients

    Case Population
    possible/No IA Patients

    Control population

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cologne University Hospital Cologne Germany 50937
    2 Duesseldorf University Hospital Duesseldorf Germany 40225
    3 Eschweiler General Hospital Eschweiler Germany 52249
    4 Frankfurt (Oder) General Hospital Frankfurt (Oder) Germany 15236
    5 Freiburg University Hospital Freiburg Germany 79106
    6 Halle University Hospital Halle (Saale) Germany
    7 Thoraxklinik at Heidelberg University Hospital Heidelberg Germany 68167
    8 Marienhospital Herne Herne Germany 44625
    9 Mannheim University Hospital Mannheim Germany 68167
    10 Prosper Hospital Recklinghausen Recklinghausen Germany
    11 Wiesbaden Bone Marrow transplantation center Wiesbaden Germany
    12 Wuerzburg University Hospital Wuerzburg Germany 97080

    Sponsors and Collaborators

    • Heidelberg University

    Investigators

    • Principal Investigator: Dieter Buchheidt, MD, Heidelberg University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Dieter Buchheidt, MD, Heidelberg University
    ClinicalTrials.gov Identifier:
    NCT01902030
    Other Study ID Numbers:
    • ASP PCR IA TISSUE-EFFUSION
    First Posted:
    Jul 17, 2013
    Last Update Posted:
    Apr 20, 2020
    Last Verified:
    Apr 1, 2020
    Additional relevant MeSH terms:
    Aspergillosis
    Pleural Effusion

    Study Results

    No Results Posted as of Apr 20, 2020