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

NCT ID: NCT01448226

Last Updated: 2020-04-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 221 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2000-01-31
• Study Completion Date: 2011-05-31

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.

Conditions

Invasive Aspergillosis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

proven or probable aspergillosis

No interventions assigned to this group

possible aspergillosis

No interventions assigned to this group

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heidelberg University

OTHER

Sponsor Role: lead

Responsible Party

Dieter Buchheidt

Prof. Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dieter Buchheidt, MD

Role: PRINCIPAL_INVESTIGATOR

Mannheim University Hospital

Locations

Innsbruck University Hospital

Innsbruck, , Austria

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 im Breisgau, , Germany

Halle University Hospital

Halle, , 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, , Germany

Countries

Austria; Germany

References

Skladny H, Buchheidt D, Baust C, Krieg-Schneider F, Seifarth W, Leib-Mosch 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. doi: 10.1128/JCM.37.12.3865-3871.1999.

Reference Type: BACKGROUND

PMID: 10565898 (View on PubMed)

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. doi: 10.1086/321887. Epub 2001 Jul 6.

Reference Type: BACKGROUND

PMID: 11462176 (View on PubMed)

Spiess B, Buchheidt D, Baust C, Skladny H, Seifarth W, Zeilfelder U, Leib-Mosch C, Morz 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. doi: 10.1128/JCM.41.5.1811-1818.2003.

Reference Type: BACKGROUND

PMID: 12734210 (View on PubMed)

Hummel M, Spiess B, Cornely OA, Dittmer M, Morz 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.

Reference Type: BACKGROUND

PMID: 20374275 (View on PubMed)

Other Identifiers

Aspergillus PCR BAL Study

Identifier Type: -

Identifier Source: org_study_id