Clinical trial NCT01430663: Diagnosing Pulmonary Aspergillosis in Patients With Hematological Malignancies: A Multicentre Prospective Evaluation of an Aspergillus PCR Assay and a Galactomannan ELISA in Bronchoalveolar Lavage Samples
Official title: Diagnosing Pulmonary Aspergillosis in Patients With Hematological Malignancies: A Multicentre Prospective Evaluation of an Aspergillus PCR Assay and a Galactomannan ELISA in Bronchoalveolar Lavage Samples
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Invasive Aspergillosis
Keywords: aspergillosis
bronchoalveolar lavage
galactomannan
pcr
hematological patients
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2011-09-08
Enrollment: 87
Sex: ALL
Minimum age (years): 5
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hematological patients at high risk for invasive aspergillosis

Brief summary: Diagnosing invasive pulmonary aspergillosis (IPA) remains a challenge in patients (pts) with hematological malignancies. The clinical significance of testing bronchoalveolar lavage (BAL) samples both with polymerase chain reaction (PCR) and Aspergillus galactomannan (GM) ELISA is unclear, and the BAL cutoff for GM has not been clearly defined yet. Using a validated nested PCR assay and a GM ELISA, we prospectively examine BAL samples from hematological patients at high risk of PA.


Eligibility criteria: Inclusion Criteria:

- hematological patients with lung infiltrates at high risk for invasive aspergillosis

Exclusion Criteria:

- patients without informed consent

Primary outcomes:
measure: Clinical significance of biomarker based diagnostic investigation in suspected invasive aspergillosis
timeFrame: up to 18 months
Secondary outcomes:
measure: Evaluation of diagnostic and therapeutic intervention concerning antifungal treatment with regard to outcome (overall survival, in months) of a fungal infection
timeFrame: up to 18 months
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Innsbruck University Hospital
city: Cologne
country: Germany
facility: Cologne University Hospital
city: Erlangen
country: Germany
facility: Erlangen University Hospital
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: Herne
country: Germany
facility: Herne University Hospital
city: Mannheim
country: Germany
facility: Mannheim University Hospital
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.