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

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ClinicalTrials.gov Identifier: NCT01448226
Recruitment Status : Completed
First Posted : October 7, 2011
Last Update Posted : April 20, 2020
Sponsor:
Information provided by (Responsible Party):
Dieter Buchheidt, 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.


Condition or disease
Invasive Aspergillosis

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.

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Study Type : Observational
Actual Enrollment : 221 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Diagnosing Invasive Aspergillosis by PCR Based Investigation of Bronchoalveolar Lavage Samples During Antifungal Therapy
Study Start Date : January 2000
Actual Primary Completion Date : January 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aspergillosis

Group/Cohort
proven or probable aspergillosis
possible aspergillosis



Biospecimen Retention:   Samples With DNA
Aliquots of BAL Samples including fungal DNA


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
immunocomprimised patients with lung infiltrates and high risk for invasive aspergillosis
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01448226


Locations
Show Show 22 study locations
Sponsors and Collaborators
Heidelberg University
Investigators
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Principal Investigator: Dieter Buchheidt, MD Mannheim University Hospital
Publications:
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Responsible Party: Dieter Buchheidt, Prof. Dr. med., Heidelberg University
ClinicalTrials.gov Identifier: NCT01448226    
Other Study ID Numbers: Aspergillus PCR BAL Study
First Posted: October 7, 2011    Key Record Dates
Last Update Posted: April 20, 2020
Last Verified: April 2020
Additional relevant MeSH terms:
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Aspergillosis
Mycoses