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

• Sponsor: Heidelberg University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01430663
• Collaborator: (none)
• Enrollment: 87
• Locations: 9
• Duration (Months): 46.1
• Patients Per Site: 9.7
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Invasive Aspergillosis

Study Design

• Study Type: Observational
• Actual Enrollment: 87 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• 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 Start Date: Apr 1, 2007
• Actual Primary Completion Date: Feb 1, 2011
• Actual Study Completion Date: Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Hematological patients with proven or probable aspergillosis
Hematological patients with possible aspergillosis

Outcome Measures

Primary Outcome Measures

1. Clinical significance of biomarker based diagnostic investigation in suspected invasive aspergillosis [up to 18 months]

Secondary Outcome Measures

1. Evaluation of diagnostic and therapeutic intervention concerning antifungal treatment with regard to outcome (overall survival, in months) of a fungal infection [up to 18 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• patients without informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Innsbruck University Hospital	Innsbruck		Austria
2	Cologne University Hospital	Cologne		Germany
3	Erlangen University Hospital	Erlangen		Germany
4	General Hospital Frankfurt (Oder)	Frankfurt (Oder)		Germany
5	Freiburg University Hospital	Freiburg		Germany
6	Halle University Hospital	Halle (Saale)		Germany
7	Herne University Hospital	Herne		Germany
8	Mannheim University Hospital	Mannheim		Germany	68167
9	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: NCT01430663
• Other Study ID Numbers: AGIHO BAL GM PCR 2007
• First Posted: Sep 8, 2011
• Last Update Posted: Apr 20, 2020
• Last Verified: Apr 1, 2020

• Keywords provided by Dieter Buchheidt, Prof. Dr. med., Heidelberg University: aspergillosis; bronchoalveolar lavage; galactomannan; pcr; hematological patients
• Additional relevant MeSH terms: Aspergillosis; Pulmonary Aspergillosis; Hematologic Neoplasms

Study Results

No Results Posted as of Apr 20, 2020