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

H

Heidelberg University

Status

Completed

Conditions

Invasive Aspergillosis

Study type

Observational

Funder types

Other

Identifiers

NCT01448226
Aspergillus PCR BAL Study

Details and patient eligibility

About

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.

Full 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.

Enrollment

221 patients

Sex

All

Ages

5 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

221 participants in 2 patient groups

proven or probable aspergillosis
possible aspergillosis

Trial contacts and locations

22

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Data sourced from clinicaltrials.gov

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