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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

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ClinicalTrials.gov Identifier: NCT01430663
Recruitment Status : Completed
First Posted : September 8, 2011
Last Update Posted : May 24, 2016
Sponsor:
Information provided by (Responsible Party):
Dieter Buchheidt, Heidelberg University

Brief Summary:
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 or disease
Invasive Aspergillosis

Study Type : Observational
Actual Enrollment : 87 participants
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
Study Start Date : April 2007
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aspergillosis
U.S. FDA Resources

Group/Cohort
Hematological patients with proven or probable aspergillosis
Hematological patients with possible aspergillosis



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

Secondary Outcome Measures :
  1. 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 ]


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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


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

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 Posted: September 8, 2011    Key Record Dates
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