Invasive Aspergillosis Clinical Trial
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
| Verified date | April 2020 |
| Source | Heidelberg University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 87 |
| Est. completion date | February 2011 |
| Est. primary completion date | February 2011 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 5 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - hematological patients with lung infiltrates at high risk for invasive aspergillosis Exclusion Criteria: - patients without informed consent |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Innsbruck University Hospital | Innsbruck | |
| Germany | 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 | |
| Germany | Würzburg University Hospital | Würzburg |
| Lead Sponsor | Collaborator |
|---|---|
| Heidelberg University |
Austria, Germany,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Clinical significance of biomarker based diagnostic investigation in suspected invasive aspergillosis | up to 18 months | ||
| Secondary | 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 |
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