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Diagnosing Pulmonary Aspergillosis in Patients With Hematological Malignancies: A Multicentre Prospective Evaluation of an Aspergillus PCR Assay and a Galactomannan ELISA in Bronchoalveolar Lavage Samples

This study has been completed.
Information provided by (Responsible Party):
Dieter Buchheidt, Heidelberg University Identifier:
First received: September 6, 2011
Last updated: May 23, 2016
Last verified: May 2016
Diagnosing invasive pulmonary aspergillosis (IPA) remains a challenge in patients (pts) with hematological malignancies. The clinical significance of testing bronchoalveolar lavage (BAL) samples both with polymerase chain reaction (PCR) and Aspergillus galactomannan (GM) ELISA is unclear, and the BAL cutoff for GM has not been clearly defined yet. Using a validated nested PCR assay and a GM ELISA, we prospectively examine BAL samples from hematological patients at high risk of PA.

Invasive Aspergillosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Diagnosing Pulmonary Aspergillosis in Patients With Hematological Malignancies: A Multicentre Prospective Evaluation of an Aspergillus PCR Assay and a Galactomannan ELISA in Bronchoalveolar Lavage Samples

Resource links provided by NLM:

Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • Clinical significance of biomarker based diagnostic investigation in suspected invasive aspergillosis [ Time Frame: up to 18 months ]

Secondary Outcome Measures:
  • Evaluation of diagnostic and therapeutic intervention concerning antifungal treatment with regard to outcome (overall survival, in months) of a fungal infection [ Time Frame: up to 18 months ]

Enrollment: 87
Study Start Date: April 2007
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Hematological patients with proven or probable aspergillosis
Hematological patients with possible aspergillosis


Ages Eligible for Study:   5 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
hematological patients at high risk for invasive aspergillosis

Inclusion Criteria:

- hematological patients with lung infiltrates at high risk for invasive aspergillosis

Exclusion Criteria:

- patients without informed consent

  Contacts and Locations
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Please refer to this study by its identifier: NCT01430663

Innsbruck University Hospital
Innsbruck, Austria
Cologne University Hospital
Cologne, Germany
Erlangen University Hospital
Erlangen, Germany
General Hospital Frankfurt (Oder)
Frankfurt (Oder), Germany
Freiburg University Hospital
Freiburg, Germany
Halle University Hospital
Halle (Saale), Germany
Herne University Hospital
Herne, Germany
Mannheim University Hospital
Mannheim, Germany, 68167
Würzburg University Hospital
Würzburg, Germany
Sponsors and Collaborators
Heidelberg University
Principal Investigator: Dieter Buchheidt, MD Mannheim University Hospital
  More Information

Responsible Party: Dieter Buchheidt, Prof. Dr. med., Heidelberg University Identifier: NCT01430663     History of Changes
Other Study ID Numbers: AGIHO BAL GM PCR 2007
Study First Received: September 6, 2011
Last Updated: May 23, 2016

Keywords provided by Heidelberg University:
bronchoalveolar lavage
hematological patients

Additional relevant MeSH terms:
Pulmonary Aspergillosis
Lung Diseases, Fungal
Lung Diseases
Respiratory Tract Diseases
Skin Diseases, Infectious
Skin Diseases processed this record on May 23, 2017