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

• Sponsor: Heidelberg University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01448226
• Collaborator: (none)
• Enrollment: 221
• Locations: 22
• Duration (Months): 136
• Patients Per Site: 10
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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	Intervention/Treatment	Phase
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.

Study Design

• 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: Jan 1, 2000
• Actual Primary Completion Date: Jan 1, 2011
• Actual Study Completion Date: May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
proven or probable aspergillosis
possible aspergillosis

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Innsbruck University Hospital	Innsbruck		Austria
2	Bielefeld evangelisches Krankenhaus	Bielefeld		Germany
3	Bochum University Hospital	Bochum		Germany
4	Cologne University Hospital	Cologne		Germany
5	Düsseldorf University Hospital	Düsseldorf		Germany
6	Erlangen University Hospital	Erlangen		Germany
7	St.-Antonius Hospital Eschweiler	Eschweiler		Germany
8	General Hospital Frankfurt (Oder)	Frankfurt (Oder)		Germany
9	Freiburg University Hospital	Freiburg		Germany
10	Halle University Hospital	Halle (Saale)		Germany
11	Heidelberg University Hospital	Heidelberg		Germany
12	Herne University Hospital	Herne		Germany
13	Bone Marrow Transplantation Centre Idar-Oberstein	Idar-Oberstein		Germany
14	Jena University Hospital	Jena		Germany
15	Ludwigshafen General Hospital	Ludwigshafen		Germany
16	Mannheim University Hospital	Mannheim		Germany	68167
17	Passau General Hospital	Passau		Germany
18	Potsdam General Hospital Ernst-von-Bergmann	Potsdam		Germany
19	Rostock University Hospital	Rostock		Germany
20	Ulm University Hospital	Ulm		Germany
21	Bone Marrow Transplantation Centre Wiesbaden	Wiesbaden		Germany
22	Würzburg University Hospital	Würzburg		Germany

Sponsors and Collaborators

• Heidelberg University

Investigators

• Principal Investigator: Dieter Buchheidt, MD, Mannheim University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.

• Responsible Party: Dieter Buchheidt, Prof. Dr. med., Heidelberg University
• ClinicalTrials.gov Identifier: NCT01448226
• Other Study ID Numbers: Aspergillus PCR BAL Study
• First Posted: Oct 7, 2011
• Last Update Posted: Apr 20, 2020
• Last Verified: Apr 1, 2020

• Additional relevant MeSH terms: Aspergillosis

Study Results

No Results Posted as of Apr 20, 2020