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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.

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
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (22)

Innsbruck University Hospital

🇦🇹

Innsbruck, Austria

Bielefeld evangelisches Krankenhaus

🇩🇪

Bielefeld, Germany

Bochum University Hospital

🇩🇪

Bochum, Germany

Cologne University Hospital

🇩🇪

Cologne, Germany

Düsseldorf University Hospital

🇩🇪

Düsseldorf, Germany

Erlangen University Hospital

🇩🇪

Erlangen, Germany

St.-Antonius Hospital Eschweiler

🇩🇪

Eschweiler, Germany

General Hospital Frankfurt (Oder)

🇩🇪

Frankfurt (Oder), Germany

Freiburg University Hospital

🇩🇪

Freiburg, Germany

Halle University Hospital

🇩🇪

Halle (Saale), Germany

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Innsbruck University Hospital
🇦🇹Innsbruck, Austria

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