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

Heidelberg University87 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Invasive Aspergillosis

Eligibility

Sex: ALLMin age: 5 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: \- hematological patients with lung infiltrates at high risk for invasive aspergillosis Exclusion Criteria: \- patients without informed consent

Locations (9)

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 im Breisgau, Germany

Halle University Hospital

Halle, Germany

Herne University Hospital

Herne, Germany

Mannheim University Hospital

Mannheim, Germany

Würzburg University Hospital

Würzburg, Germany

Outcomes

Primary Outcomes

Clinical significance of biomarker based diagnostic investigation in suspected invasive aspergillosis

Time frame: up to 18 months

Secondary Outcomes

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