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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dieter Buchheidt, University of Heidelberg
ClinicalTrials.gov Identifier:
NCT01448226
First received: October 5, 2011
Last updated: October 6, 2011
Last verified: October 2011
  Purpose

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.


Condition
Invasive Aspergillosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Diagnosing Invasive Aspergillosis by PCR Based Investigation of Bronchoalveolar Lavage Samples During Antifungal Therapy

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Biospecimen Retention:   Samples With DNA

Aliquots of BAL Samples including fungal DNA


Enrollment: 221
Study Start Date: January 2000
Study Completion Date: May 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
proven or probable aspergillosis
possible aspergillosis

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.

  Eligibility

Ages Eligible for Study:   5 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

immunocomprimised patients with lung infiltrates and high risk for invasive aspergillosis

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01448226

Locations
Austria
Innsbruck University Hospital
Innsbruck, Austria
Germany
Bielefeld evangelisches Krankenhaus
Bielefeld, Germany
Bochum University Hospital
Bochum, Germany
Cologne University Hospital
Cologne, Germany
Düsseldorf University Hospital
Düsseldorf, Germany
Erlangen University Hospital
Erlangen, Germany
St.-Antonius Hospital Eschweiler
Eschweiler, Germany
General Hospital Frankfurt (Oder)
Frankfurt (Oder), Germany
Freiburg University Hospital
Freiburg, Germany
Halle University Hospital
Halle (Saale), Germany
Heidelberg University Hospital
Heidelberg, Germany
Herne University Hospital
Herne, Germany
Bone Marrow Transplantation Centre Idar-Oberstein
Idar-Oberstein, Germany
Jena University Hospital
Jena, Germany
Ludwigshafen General Hospital
Ludwigshafen, Germany
Mannheim University Hospital
Mannheim, Germany, 68167
Passau General Hospital
Passau, Germany
Potsdam General Hospital Ernst-von-Bergmann
Potsdam, Germany
Rostock University Hospital
Rostock, Germany
Ulm University Hospital
Ulm, Germany
Bone Marrow Transplantation Centre Wiesbaden
Wiesbaden, Germany
Würzburg University Hospital
Würzburg, Germany
Sponsors and Collaborators
Heidelberg University
Investigators
Principal Investigator: Dieter Buchheidt, MD Mannheim University Hospital
  More Information

Publications:
Responsible Party: Dieter Buchheidt, Prof. Dr. med., University of Heidelberg
ClinicalTrials.gov Identifier: NCT01448226     History of Changes
Other Study ID Numbers: Aspergillus PCR BAL Study
Study First Received: October 5, 2011
Last Updated: October 6, 2011
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Aspergillosis
Hyalohyphomycosis
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Skin Diseases

ClinicalTrials.gov processed this record on September 30, 2014