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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01430663
First Posted: September 8, 2011
Last Update Posted: May 24, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dieter Buchheidt, Heidelberg University
  Purpose
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.

Condition
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 Dieter Buchheidt, 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)
Groups/Cohorts
Hematological patients with proven or probable aspergillosis
Hematological patients with possible aspergillosis

  Eligibility

Information from the National Library of Medicine

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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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- patients without informed consent

  Contacts and Locations
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): NCT01430663


Locations
Austria
Innsbruck University Hospital
Innsbruck, Austria
Germany
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
Investigators
Principal Investigator: Dieter Buchheidt, MD Mannheim University Hospital
  More Information

Publications:
Responsible Party: Dieter Buchheidt, Prof. Dr. med., Heidelberg University
ClinicalTrials.gov Identifier: NCT01430663     History of Changes
Other Study ID Numbers: AGIHO BAL GM PCR 2007
First Submitted: September 6, 2011
First Posted: September 8, 2011
Last Update Posted: May 24, 2016
Last Verified: May 2016

Keywords provided by Dieter Buchheidt, Heidelberg University:
aspergillosis
bronchoalveolar lavage
galactomannan
pcr
hematological patients

Additional relevant MeSH terms:
Aspergillosis
Pulmonary Aspergillosis
Mycoses
Hyalohyphomycosis
Dermatomycoses
Lung Diseases, Fungal
Skin Diseases, Infectious
Skin Diseases
Lung Diseases
Respiratory Tract Diseases