Application of an Electronic Nose in the Early Detection of ASpergillosis

Pulmonary Invasive Aspergillosis Clinical Trial

— AENEAS  

Official title:

The Application of an Electronic Nose in the Early Detection of ASpergillosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01395446
• Other study ID #: 28062009
• Status: Completed
• Phase: N/A
• First received: June 29, 2011
• Last updated: June 23, 2015
• Start date: January 2010
• Est. completion date: December 2012

Study information

• Verified date: June 2015
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to establish the accuracy with which the eNose can discriminate patients with invasive pulmonary aspergillosis from controls.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aspergillosis
• Invasive Pulmonary Aspergillosis
• Pulmonary Invasive Aspergillosis

Locations

Country	Name	City	State
Netherlands	Department of Hematology, Academic Medical Center	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	accuracy with which the Cyranose can discriminate between patients with probable or proven invasive pulmonary aspergillosis and neutropenic controls with fever	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	4 days	No