Clinical trial · Observational
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
NCT01430663CI-TRIAL-00044744completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Invasive Aspergillosis | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Hematological patients with proven or probable aspergillosis
- label
- Hematological patients with possible aspergillosis
Primary outcomes (1)
- measure
- Clinical significance of biomarker based diagnostic investigation in suspected invasive aspergillosis
- timeFrame
- up to 18 months
Secondary outcomes (1)
- measure
- Evaluation of diagnostic and therapeutic intervention concerning antifungal treatment with regard to outcome (overall survival, in months) of a fungal infection
- timeFrame
- up to 18 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: \- hematological patients with lung infiltrates at high risk for invasive aspergillosis Exclusion Criteria: \- patients without informed consent
References
Publications (4)
- BACKGROUNDSkladny 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. PMID 10565898
- BACKGROUNDBuchheidt 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. PMID 11462176
- BACKGROUNDSpiess 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. PMID 12734210
- BACKGROUNDHummel 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. PMID 20374275