Clinical trial NCT01448226: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Invasive Aspergillosis
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2011-10-07
Enrollment: 221
Sex: ALL
Minimum age (years): 5
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: immunocomprimised patients with lung infiltrates and high risk for invasive aspergillosis

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Innsbruck University Hospital
city: Bielefeld
country: Germany
facility: Bielefeld evangelisches Krankenhaus
city: Bochum
country: Germany
facility: Bochum University Hospital
city: Cologne
country: Germany
facility: Cologne University Hospital
city: Düsseldorf
country: Germany
facility: Düsseldorf University Hospital
city: Erlangen
country: Germany
facility: Erlangen University Hospital
city: Eschweiler
country: Germany
facility: St.-Antonius Hospital Eschweiler
city: Frankfurt (Oder)
country: Germany
facility: General Hospital Frankfurt (Oder)
city: Freiburg
country: Germany
facility: Freiburg University Hospital
city: Halle (Saale)
country: Germany
facility: Halle University Hospital
city: Heidelberg
country: Germany
facility: Heidelberg University Hospital
city: Herne
country: Germany
facility: Herne University Hospital
city: Idar-Oberstein
country: Germany
facility: Bone Marrow Transplantation Centre Idar-Oberstein
city: Jena
country: Germany
facility: Jena University Hospital
city: Ludwigshafen
country: Germany
facility: Ludwigshafen General Hospital
city: Mannheim
country: Germany
facility: Mannheim University Hospital
city: Passau
country: Germany
facility: Passau General Hospital
city: Potsdam
country: Germany
facility: Potsdam General Hospital Ernst-von-Bergmann
city: Rostock
country: Germany
facility: Rostock University Hospital
city: Ulm
country: Germany
facility: Ulm University Hospital
city: Wiesbaden
country: Germany
facility: Bone Marrow Transplantation Centre Wiesbaden
city: Würzburg
country: Germany
facility: Würzburg University Hospital
Study officials:
affiliation: Mannheim University Hospital
name: Dieter Buchheidt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.