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

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.

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Key information

Conditions

Invasive Aspergillosis Aspergillosis Bacterial Infections and Mycoses Disease Attributes Disease Progression Infections Mycoses Pathologic Complete Response Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

5 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Innsbruck University Hospital, Innsbruck, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

hematological patients with lung infiltrates at high risk for invasive aspergillosis

Exclusion criteria

patients without informed consent

Treatment and study plan

Primary outcomes

Clinical significance of biomarker based diagnostic investigation in suspected invasive aspergillosis

Time frame: up to 18 months

Secondary outcomes

Evaluation of diagnostic and therapeutic intervention concerning antifungal treatment with regard to outcome (overall survival, in months) of a fungal infection

Time frame: up to 18 months

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Registry information

Important dates

Study start: 2007
Primary completion: 2011
Study completion: 2011
First posted: Sep 8, 2011
Registry last updated: Apr 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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