the Application of an Electronic Nose in the Early detection of ASpergillosis

• Conditions: fungal pneumonia; invasive pulmonary mycosis; 10018849; 10017528; 10024970

• Registration Number: NL-OMON33126
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 80

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, or
2. the inability to perform the breathing manoeuvre needed for eNose-analysis of exhaled air

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To establish the accuracy with which the Cyranose* can discriminate patients<br /><br>with probable or proven invasive pulmonary aspergillosis from neutropenic<br /><br>controls with fever.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To establish whether neutropenic patients with fever but no sign of<br /><br>aspergillosis can be discriminated from healthy subjects, thus measuring the<br /><br>combined influence of chemotherapy, neutropenia, antibiotics and fever on the<br /><br>algorithm used for the main objective.</p><br>