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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date October 5, 2011
First Posted Date October 7, 2011
Last Update Posted Date April 20, 2020
Study Start Date January 2000
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Diagnosing Invasive Aspergillosis by Polymerase Chain Reaction (PCR) Based Investigation of Bronchoalveolar Lavage Samples During Antifungal Therapy
Official Title Diagnosing Invasive Aspergillosis by PCR Based Investigation of Bronchoalveolar Lavage Samples During Antifungal Therapy
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Aliquots of BAL Samples including fungal DNA
Sampling Method Probability Sample
Study Population immunocomprimised patients with lung infiltrates and high risk for invasive aspergillosis
Condition Invasive Aspergillosis
Intervention Not Provided
Study Groups/Cohorts
  • proven or probable aspergillosis
  • possible aspergillosis
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October¬†6,¬†2011)
221
Original Actual Enrollment Same as current
Actual Study Completion Date May 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 5 Years to 85 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Austria,   Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT01448226
Other Study ID Numbers Aspergillus PCR BAL Study
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dieter Buchheidt, Heidelberg University
Study Sponsor Heidelberg University
Collaborators Not Provided
Investigators
Principal Investigator: Dieter Buchheidt, MD Mannheim University Hospital
PRS Account Heidelberg University
Verification Date April 2020