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

April 17, 2020 updated by: Dieter Buchheidt, Heidelberg University
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

87

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria
        • Innsbruck University Hospital
  • Germany
      • Cologne, Germany
        • Cologne University Hospital
      • Erlangen, Germany
        • Erlangen University Hospital
      • Frankfurt (Oder), Germany
        • General Hospital Frankfurt (Oder)
      • Freiburg, Germany
        • Freiburg University Hospital
      • Halle (Saale), Germany
        • Halle University Hospital
      • Herne, Germany
        • Herne University Hospital
      • Mannheim, Germany, 68167
        • Mannheim University Hospital
      • Würzburg, Germany
        • Würzburg University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

hematological patients at high risk for invasive aspergillosis

Description

Inclusion Criteria:

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

Exclusion Criteria:

- patients without informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Hematological patients with proven or probable aspergillosis
Hematological patients with possible aspergillosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical significance of biomarker based diagnostic investigation in suspected invasive aspergillosis
Time Frame: up to 18 months
up to 18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg University

Investigators

  • Principal Investigator: Dieter Buchheidt, MD, Mannheim University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

September 6, 2011

First Submitted That Met QC Criteria

September 7, 2011

First Posted (Estimate)

September 8, 2011

Study Record Updates

Last Update Posted (Actual)

April 20, 2020

Last Update Submitted That Met QC Criteria

April 17, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGIHO BAL GM PCR 2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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