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, Heidelberg University
ClinicalTrials.gov Identifier:
NCT01430663
First received: September 6, 2011
Last updated: April 4, 2014
Last verified: April 2014
  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 Heidelberg University:

Primary Outcome Measures:
  • Clinical significance of biomarker based diagnostic investigation in suspected invasive aspergillosis [ Time Frame: December 2014 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • n.a. [ Time Frame: n.a. ] [ Designated as safety issue: No ]

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
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: 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
Study First Received: September 6, 2011
Last Updated: April 4, 2014
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Aspergillosis
Hematologic Neoplasms
Pulmonary Aspergillosis
Hyalohyphomycosis
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Skin Diseases
Neoplasms by Site
Neoplasms
Hematologic Diseases
Lung Diseases, Fungal
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 11, 2014