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

Purpose

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
Invasive Aspergillosis

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Retrospective
Official Title:	Diagnosing Invasive Aspergillosis by PCR Based Investigation of Bronchoalveolar Lavage Samples During Antifungal Therapy

Resource links provided by NLM:

MedlinePlus related topics: Aspergillosis

Drug Information available for: Miconazole nitrate Miconazole Clotrimazole

U.S. FDA Resources

Further study details as provided by University of Heidelberg:

Biospecimen Retention: Samples With DNA

Aliquots of BAL Samples including fungal DNA

Enrollment:	221
Study Start Date:	January 2000
Study Completion Date:	May 2011
Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts
proven or probable aspergillosis
possible 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.

Eligibility

Ages Eligible for Study:	5 Years to 85 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01448226

Locations

Austria
Innsbruck University Hospital
Innsbruck, Austria
Germany
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
Heidelberg University Hospital
Heidelberg, Germany
Herne University Hospital
Herne, Germany
Bone Marrow Transplantation Centre Idar-Oberstein
Idar-Oberstein, Germany
Jena University Hospital
Jena, Germany
Ludwigshafen General Hospital
Ludwigshafen, Germany
Mannheim University Hospital
Mannheim, Germany, 68167
Passau General Hospital
Passau, Germany
Potsdam General Hospital Ernst-von-Bergmann
Potsdam, Germany
Rostock University Hospital
Rostock, Germany
Ulm University Hospital
Ulm, Germany
Bone Marrow Transplantation Centre Wiesbaden
Wiesbaden, Germany
Würzburg University Hospital
Würzburg, Germany

Sponsors and Collaborators

University of Heidelberg

Investigators

Principal Investigator:

Dieter Buchheidt, MD

Mannheim University Hospital

More Information

Publications:

Skladny H, Buchheidt D, Baust C, Krieg-Schneider F, Seifarth W, Leib-Mösch C, Hehlmann R. Specific detection of Aspergillus species in blood and bronchoalveolar lavage samples of immunocompromised patients by two-step PCR. J Clin Microbiol. 1999 Dec;37(12):3865-71.

Buchheidt D, Baust C, Skladny H, Ritter J, Suedhoff T, Baldus M, Seifarth W, Leib-Moesch C, Hehlmann R. Detection of Aspergillus species in blood and bronchoalveolar lavage samples from immunocompromised patients by means of 2-step polymerase chain reaction: clinical results. Clin Infect Dis. 2001 Aug 15;33(4):428-35. Epub 2001 Jul 6.

Spiess B, Buchheidt D, Baust C, Skladny H, Seifarth W, Zeilfelder U, Leib-Mösch C, Mörz H, Hehlmann R. Development of a LightCycler PCR assay for detection and quantification of Aspergillus fumigatus DNA in clinical samples from neutropenic patients. J Clin Microbiol. 2003 May;41(5):1811-8.

Hummel M, Spiess B, Cornely OA, Dittmer M, Mörz H, Buchheidt D. Aspergillus PCR testing: results from a prospective PCR study within the AmBiLoad trial. Eur J Haematol. 2010 Aug;85(2):164-9. Epub 2010 Apr 1.

Responsible Party:	Dieter Buchheidt, Prof. Dr. med., University of Heidelberg
ClinicalTrials.gov Identifier:	NCT01448226 History of Changes
Other Study ID Numbers:	Aspergillus PCR BAL Study
Study First Received:	October 5, 2011
Last Updated:	October 6, 2011
Health Authority:	Germany: Ethics Commission

Additional relevant MeSH terms:

Aspergillosis
Mycoses
Antifungal Agents

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013