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

Invasive Aspergillosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01448226
• Other study ID #: Aspergillus PCR BAL Study
• Status: Completed
• Start date: January 2000
• Est. completion date: May 2011

Study information

• Verified date: April 2020
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: May 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Aspergillosis
• Invasive Aspergillosis

Locations

Country	Name	City	State
Austria	Innsbruck University Hospital	Innsbruck
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	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

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Countries where clinical trial is conducted

Austria,  Germany, 

References & Publications (4)

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. — View Citation

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. doi: 10.1111/j.1600-0609.2010.01452.x. Epub 2010 Apr 1. — View Citation

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. — View Citation

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. — View Citation