NCT01448226

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

Diagnosing Invasive Aspergillosis by PCR Based Investigation of Bronchoalveolar Lavage Samples During Antifungal Therapy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 221 (actual)
• Sponsor: Heidelberg University · Academic / Other
• Sex: All
• Age: 5 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Invasive Aspergillosis

Timeline

• Start date: 2000-01-01
• Primary completion: 2011-01-01
• Completion: 2011-05-01
• First posted: 2011-10-07
• Last updated: 2020-04-20

Locations

22 sites across 2 countries: Austria, Germany