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:

Information provided by (Responsible Party):

Dieter Buchheidt, University of Heidelberg

ClinicalTrials.gov Identifier:

NCT01430663

First received: September 6, 2011

Last updated: September 7, 2011

Last verified: September 2011

History of Changes

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:

MedlinePlus related topics: Aspergillosis Cancer

U.S. FDA Resources

Further study details as provided by University of Heidelberg:

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

Ages Eligible for Study:	5 Years to 80 Years
Genders Eligible for Study:	Both
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

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

University of Heidelberg

Investigators

Principal Investigator:

Dieter Buchheidt, MD

Mannheim University Hospital

More Information

Publications:

Skladny H, Buchheidt D, Baust C, Krieg-Schneider F, Seifarth W, Leib-Mösch C, Hehlmann R. Specific detection of Aspergillus species in blood and bronchoalveolar lavage samples of immunocompromised patients by two-step PCR. J Clin Microbiol. 1999 Dec;37(12):3865-71.

Buchheidt D, Baust C, Skladny H, Ritter J, Suedhoff T, Baldus M, Seifarth W, Leib-Moesch C, Hehlmann R. Detection of Aspergillus species in blood and bronchoalveolar lavage samples from immunocompromised patients by means of 2-step polymerase chain reaction: clinical results. Clin Infect Dis. 2001 Aug 15;33(4):428-35. Epub 2001 Jul 6.

Spiess B, Buchheidt D, Baust C, Skladny H, Seifarth W, Zeilfelder U, Leib-Mösch C, Mörz H, Hehlmann R. Development of a LightCycler PCR assay for detection and quantification of Aspergillus fumigatus DNA in clinical samples from neutropenic patients. J Clin Microbiol. 2003 May;41(5):1811-8.

Hummel M, Spiess B, Cornely OA, Dittmer M, Mörz H, Buchheidt D. Aspergillus PCR testing: results from a prospective PCR study within the AmBiLoad trial. Eur J Haematol. 2010 Aug;85(2):164-9. Epub 2010 Apr 1.

Responsible Party:	Dieter Buchheidt, Prof. Dr. med., University of Heidelberg
ClinicalTrials.gov Identifier:	NCT01430663 History of Changes
Other Study ID Numbers:	AGIHO BAL GM PCR 2007
Study First Received:	September 6, 2011
Last Updated:	September 7, 2011
Health Authority:	Germany: Ethics Commission

Keywords provided by University of Heidelberg:

aspergillosis
bronchoalveolar lavage
galactomannan
pcr
hematological patients

Additional relevant MeSH terms:

Aspergillosis
Hematologic Neoplasms
Pulmonary Aspergillosis
Mycoses
Neoplasms by Site

Neoplasms
Hematologic Diseases
Lung Diseases, Fungal
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013

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