Trial Information
The Application of an Electronic Nose in the Early Detection of ASpergillosis
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
Exclusion Criteria:
1. a previously diagnosed invasive mycosis
2. the inability to perform the breathing manoeuvre needed for eNose-analysis of exhaled
air
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
accuracy with which the Cyranose can discriminate between patients with probable or proven invasive pulmonary aspergillosis and neutropenic controls with fever
Outcome Description:
The cross-validated accuracy with which the Cyranose can discriminate between patients with probable or proven invasive pulmonary aspergillosis and neutropenic controls with fever, defined as the percentage of correctly classified patients using the leave-one out method
Safety Issue:
No
Authority:
Netherlands: Medical Ethics Review Committee (METC)
Study ID:
28062009
NCT ID:
NCT01395446
Start Date:
January 2010
Completion Date:
Related Keywords:
- Pulmonary Invasive Aspergillosis
- Aspergillosis
- Invasive Pulmonary Aspergillosis