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

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ClinicalTrials.gov Identifier: NCT01902030
Recruitment Status : Enrolling by invitation
First Posted : July 17, 2013
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
Dieter Buchheidt, Heidelberg University

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
Aspergillosis Immunosuppression

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Study Type : Observational
Estimated 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 : January 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aspergillosis

Group/Cohort
Proven/Probable IA Patients
Case Population
possible/No IA Patients
Control population



Primary Outcome Measures :
  1. Calculation of sensitivity, Specificity, positive predictive value, negative predictive value and diagnostic odds ratio [ Time Frame: 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


Biospecimen Retention:   Samples With DNA
Fungal DNA, no human DNA


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  • Immunocompromised individuals with suspicion of harbouring an invasive fungal infection
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01902030


Locations
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Germany
Cologne University Hospital
Cologne, Germany, 50937
Duesseldorf University Hospital
Duesseldorf, Germany, 40225
Eschweiler General Hospital
Eschweiler, Germany, 52249
Frankfurt (Oder) General Hospital
Frankfurt (Oder), Germany, 15236
Freiburg University Hospital
Freiburg, Germany, 79106
Halle University Hospital
Halle (Saale), Germany
Thoraxklinik at Heidelberg University Hospital
Heidelberg, Germany, 68167
Marienhospital Herne
Herne, Germany, 44625
Mannheim University Hospital
Mannheim, Germany, 68167
Prosper Hospital Recklinghausen
Recklinghausen, Germany
Wiesbaden Bone Marrow transplantation center
Wiesbaden, Germany
Wuerzburg University Hospital
Wuerzburg, Germany, 97080
Sponsors and Collaborators
Heidelberg University
Investigators
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Principal Investigator: Dieter Buchheidt, MD Heidelberg University

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dieter Buchheidt, MD, Heidelberg University
ClinicalTrials.gov Identifier: NCT01902030     History of Changes
Other Study ID Numbers: ASP PCR IA TISSUE-EFFUSION
First Posted: July 17, 2013    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
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Aspergillosis
Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases
Mycoses