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

NCT ID: NCT01430663

Last Updated: 2020-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

87 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-04-30

Study Completion Date

2011-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Invasive Aspergillosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Hematological patients with proven or probable aspergillosis

No interventions assigned to this group

Hematological patients with possible aspergillosis

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\- patients without informed consent
Minimum Eligible Age

5 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heidelberg University

OTHER

Sponsor Role lead

Responsible Party

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Dieter Buchheidt

Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dieter Buchheidt, MD

Role: PRINCIPAL_INVESTIGATOR

Mannheim University Hospital

Locations

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Innsbruck University Hospital

Innsbruck, , Austria

Site Status

Cologne University Hospital

Cologne, , Germany

Site Status

Erlangen University Hospital

Erlangen, , Germany

Site Status

General Hospital Frankfurt (Oder)

Frankfurt (Oder), , Germany

Site Status

Freiburg University Hospital

Freiburg im Breisgau, , Germany

Site Status

Halle University Hospital

Halle, , Germany

Site Status

Herne University Hospital

Herne, , Germany

Site Status

Mannheim University Hospital

Mannheim, , Germany

Site Status

Würzburg University Hospital

Würzburg, , Germany

Site Status

Countries

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Austria Germany

References

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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

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AGIHO BAL GM PCR 2007

Identifier Type: -

Identifier Source: org_study_id

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