Diagnosing Invasive Aspergillosis by Polymerase Chain Reaction (PCR) Based Investigation of Bronchoalveolar Lavage Samples During Antifungal Therapy

Completed

• Conditions: Invasive Aspergillosis

• Registration Number: NCT01448226
• Lead Sponsor: Heidelberg University

Brief Summary

Invasive pulmonary aspergillosis (IPA) remains a major cause for morbidity and mortality in patients (pts) with hematologic malignancies. As culture-based methods only yield results in a minority of patients, using non-culture-based methods for detection of aspergillosis in clinical specimens becomes increasingly important. Analyzing bronchoalveolar lavage (BAL) samples with polymerase chain reaction (PCR) is promising, however, the influence of current antifungal drugs on the performance of this diagnostic tool remains controversial.

The aim of the trial is to elucidate on the performance of BAL PCR under antifungal treatment.

Detailed Description

Invasive pulmonary aspergillosis (IPA) remains a major cause for morbidity and mortality in patients (pts) with hematologic malignancies. As culture-based methods only yield results in a minority of patients, using non-culture-based methods for detection of aspergillosis in clinical specimens becomes increasingly important. Analyzing bronchoalveolar lavage (BAL) samples with polymerase chain reaction (PCR) is promising, however, the influence of current antifungal drugs on the performance of this diagnostic tool remains controversial.

The aim of the trial is to elucidate on the performance of BAL PCR under antifungal treatment.

Patients with high risk of invasive aspergillosis and lung infiltrates are sampled via BAL, the sample is analyzed for fungal DNA by Apsergillus specific PCR. Clinical data including treatment data is assessed and evaluated.

Study Timeline

• Study Start: 2000-01
• Primary Completion: 2011-01
• Study Completion: 2011-05
• Study First Submitted: 2011-10-05
• Study First Submitted QC: 2011-10-06
• Study First Posted: 2011-10-07
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-17
• Last Update Posted: 2020-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 221

Inclusion Criteria

• immunocomprimised patients with high risk of invasive aspergillosis and lung infiltrates
• informed consent

Exclusion Criteria

• Children under the age of 5 years
• Informed consent not available

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (22)

Innsbruck University Hospital; 🇦🇹 Innsbruck, Austria

Bochum University Hospital; 🇩🇪 Bochum, Germany

Bielefeld evangelisches Krankenhaus; 🇩🇪 Bielefeld, Germany

Cologne University Hospital; 🇩🇪 Cologne, Germany

Düsseldorf University Hospital; 🇩🇪 Düsseldorf, Germany

Erlangen University Hospital; 🇩🇪 Erlangen, Germany

Bone Marrow Transplantation Centre Idar-Oberstein; 🇩🇪 Idar-Oberstein, Germany

Ludwigshafen General Hospital; 🇩🇪 Ludwigshafen, Germany

St.-Antonius Hospital Eschweiler; 🇩🇪 Eschweiler, Germany

General Hospital Frankfurt (Oder); 🇩🇪 Frankfurt (Oder), Germany

Freiburg University Hospital; 🇩🇪 Freiburg, Germany

Heidelberg University Hospital; 🇩🇪 Heidelberg, Germany

Halle University Hospital; 🇩🇪 Halle (Saale), Germany

Herne University Hospital; 🇩🇪 Herne, Germany

Jena University Hospital; 🇩🇪 Jena, Germany

Mannheim University Hospital; 🇩🇪 Mannheim, Germany

Rostock University Hospital; 🇩🇪 Rostock, Germany

Bone Marrow Transplantation Centre Wiesbaden; 🇩🇪 Wiesbaden, Germany

Passau General Hospital; 🇩🇪 Passau, Germany

Ulm University Hospital; 🇩🇪 Ulm, Germany

Potsdam General Hospital Ernst-von-Bergmann; 🇩🇪 Potsdam, Germany

Würzburg University Hospital; 🇩🇪 Würzburg, Germany