CClinicalTrials.gg
Sign In
CompletedNCT01430663Updated Apr 20, 2020

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

An observational study in Invasive Aspergillosis, sponsored by Heidelberg University. Completed at 9 sites in 2 countries. Open to participants aged 5 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-04-20.

Sponsored by Heidelberg University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
87
Ages
5 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Invasive Aspergillosis

Keywords

  • aspergillosis
  • bronchoalveolar lavage
  • galactomannan
  • pcr
  • hematological patients
03

In context

Aspergillosis

201 studies on the registry are indexed under Aspergillosis; 22 are open to participants now.

This study's enrollment of 87 is below the median of 150 across 81 observational studies indexed under Aspergillosis.

Browse Aspergillosis studies →

Lead sponsor

Heidelberg University is the lead sponsor of 279 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

hematological patients at high risk for invasive aspergillosis

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • patients without informed consent
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
87 participants (actual)

Groups and cohorts

  • Hematological patients with proven or probable aspergillosis
  • Hematological patients with possible aspergillosis
06

What researchers measure

Primary outcomes

  1. Clinical significance of biomarker based diagnostic investigation in suspected invasive aspergillosis

    Time frame: up to 18 months

Secondary outcomes

  1. 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

07

Study locations

9 sites
  • Innsbruck University Hospital
    Innsbruck, Austria
  • Cologne University Hospital
    Cologne, Germany
  • Erlangen University Hospital
    Erlangen, Germany
  • General Hospital Frankfurt (Oder)
    Frankfurt (Oder), Germany
  • Freiburg University Hospital
    Freiburg, Germany
  • Halle University Hospital
    Halle (Saale), Germany
  • Herne University Hospital
    Herne, Germany
  • Mannheim University Hospital
    Mannheim, 68167, Germany
  • Würzburg University Hospital
    Würzburg, Germany
08

References and documents

Publications

  • 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. PubMed 10565898 ↗
  • 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. PubMed 11462176 ↗
  • 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. PubMed 12734210 ↗
  • 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. PubMed 20374275 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01430663
Lead sponsor
Heidelberg University
Responsible party
Dieter Buchheidt (Prof. Dr. med., Heidelberg University) — Principal investigator
First posted
Sep 8, 2011
Start date
Apr 2007
Primary completion
Feb 2011
Completion
Feb 2011
Last update
Apr 20, 2020

Study contacts

Dieter Buchheidt, MD
principal investigator · Mannheim University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Aspergillosis→

Other studies from this sponsor

Heidelberg University

Start the discussion