Diagnosing Invasive Aspergillosis by Polymerase Chain Reaction (PCR) Based Investigation of Bronchoalveolar Lavage Samples During Antifungal Therapy

April 17, 2020 updated by: Dieter Buchheidt, Heidelberg University

Diagnosing Invasive Aspergillosis by PCR Based Investigation of Bronchoalveolar Lavage Samples During Antifungal Therapy

Invasive pulmonary aspergillosis (IPA) remains a major cause for morbidity and mortality in patients (pts) with hematologic malignancies. As culture-based methods only yield results in a minority of patients, using non-culture-based methods for detection of aspergillosis in clinical specimens becomes increasingly important. Analyzing bronchoalveolar lavage (BAL) samples with polymerase chain reaction (PCR) is promising, however, the influence of current antifungal drugs on the performance of this diagnostic tool remains controversial.

The aim of the trial is to elucidate on the performance of BAL PCR under antifungal treatment.

Study Overview

Status

Completed

Conditions

Detailed Description

Invasive pulmonary aspergillosis (IPA) remains a major cause for morbidity and mortality in patients (pts) with hematologic malignancies. As culture-based methods only yield results in a minority of patients, using non-culture-based methods for detection of aspergillosis in clinical specimens becomes increasingly important. Analyzing bronchoalveolar lavage (BAL) samples with polymerase chain reaction (PCR) is promising, however, the influence of current antifungal drugs on the performance of this diagnostic tool remains controversial.

The aim of the trial is to elucidate on the performance of BAL PCR under antifungal treatment.

Patients with high risk of invasive aspergillosis and lung infiltrates are sampled via BAL, the sample is analyzed for fungal DNA by Apsergillus specific PCR. Clinical data including treatment data is assessed and evaluated.

Study Type

Observational

Enrollment (Actual)

221

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria
        • Innsbruck University Hospital
  • Germany
      • Bielefeld, Germany
        • Bielefeld evangelisches Krankenhaus
      • Bochum, Germany
        • Bochum University Hospital
      • Cologne, Germany
        • Cologne University Hospital
      • Düsseldorf, Germany
        • Düsseldorf University Hospital
      • Erlangen, Germany
        • Erlangen University Hospital
      • Eschweiler, Germany
        • St.-Antonius Hospital Eschweiler
      • Frankfurt (Oder), Germany
        • General Hospital Frankfurt (Oder)
      • Freiburg, Germany
        • Freiburg University Hospital
      • Halle (Saale), Germany
        • Halle University Hospital
      • Heidelberg, Germany
        • Heidelberg University Hospital
      • Herne, Germany
        • Herne University Hospital
      • Idar-Oberstein, Germany
        • Bone Marrow Transplantation Centre Idar-Oberstein
      • Jena, Germany
        • Jena University Hospital
      • Ludwigshafen, Germany
        • Ludwigshafen General Hospital
      • Mannheim, Germany, 68167
        • Mannheim University Hospital
      • Passau, Germany
        • Passau General Hospital
      • Potsdam, Germany
        • Potsdam General Hospital Ernst-von-Bergmann
      • Rostock, Germany
        • Rostock University Hospital
      • Ulm, Germany
        • Ulm University Hospital
      • Wiesbaden, Germany
        • Bone Marrow Transplantation Centre Wiesbaden
      • Würzburg, Germany
        • Würzburg University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 85 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

immunocomprimised patients with lung infiltrates and high risk for invasive aspergillosis

Description

Inclusion Criteria:

  • immunocomprimised patients with high risk of invasive aspergillosis and lung infiltrates
  • informed consent

Exclusion Criteria:

  • Children under the age of 5 years
  • Informed consent not available

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
proven or probable aspergillosis
possible aspergillosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg University

Investigators

  • Principal Investigator: Dieter Buchheidt, MD, Mannheim University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2000

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

October 5, 2011

First Submitted That Met QC Criteria

October 6, 2011

First Posted (Estimate)

October 7, 2011

Study Record Updates

Last Update Posted (Actual)

April 20, 2020

Last Update Submitted That Met QC Criteria

April 17, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Aspergillus PCR BAL Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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