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
- Conditions
- Invasive Aspergillosis
- Registration Number
- NCT01430663
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 87
- hematological patients with lung infiltrates at high risk for invasive aspergillosis
- patients without informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical significance of biomarker based diagnostic investigation in suspected invasive aspergillosis up to 18 months
- Secondary Outcome Measures
Name Time Method Evaluation of diagnostic and therapeutic intervention concerning antifungal treatment with regard to outcome (overall survival, in months) of a fungal infection up to 18 months
Trial Locations
- Locations (9)
Herne University Hospital
🇩🇪Herne, Germany
Mannheim University Hospital
🇩🇪Mannheim, Germany
Würzburg University Hospital
🇩🇪Würzburg, Germany
Halle University Hospital
🇩🇪Halle (Saale), Germany
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, Germany