invasive pulmonary aspergillosis
Conditions
Interventions
Exhaled breath analysis using an electronic nose and gas chromatography-mass spectometry.
Sponsors
AMC, Amsterdam
Eligibility
Inclusion criteria
Inclusion criteria: Patients that: 1. Are 18 years of age or older; 2. Will undergo treatment for a hematological malignancy expected to result in grade 4 neutropenia (according to CTCAE 3.0, i.e. <0.5 x 109 neutrophils/L) of prolonged duration (i.e., more than 7 days), e.g. hematopoietic stem cell transplantation or induction/consolidation treatment for acute myeloid leukaemia; 3. Have given written informed consent. If the neutropenic episode is part of a sequence of prolonged neutropenias, the informed consent will apply to all neutropenic episodes. The moment anti-mold treatment is started, the patient will go off-protocol after analysis of exhaled air using the eNose.
Exclusion criteria
Exclusion criteria: 1. A previously diagnosed invasive mycosis; 2. The inability to perform the breathing manoeuvre needed for eNose-analysis of exhaled air.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The accuracy with which an eNose can discriminate between patients with probable or proven invasive pulmonary aspergillosis and neutropenic controls with fever, as measured by the cross-validated values of the sensitivity, specificity and accuracy of the predictive algorithm. | — |
Secondary
| Measure | Time frame |
|---|---|
| The accuracy in discriminating neutropenic controls with fever from healthy volunteers using the algorithm derived for the primary endpoint, as measured by the cross-validated values of the sensitivity, specificity and accuracy of the predictive algorithm. | — |
Contacts
Public ContactKoen Heer, de
P.O. Box 22660
Outcome results
None listed