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Clinical Trials/NCT01395446
NCT01395446
Completed
Not Applicable

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

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1 site in 1 country52 target enrollmentJanuary 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulmonary Invasive Aspergillosis
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Enrollment
52
Locations
1
Primary Endpoint
accuracy with which the Cyranose can discriminate between patients with probable or proven invasive pulmonary aspergillosis and neutropenic controls with fever
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
January 2010
End Date
December 2012
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

K. de Heer

Drs. K. de Heer

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Eligibility Criteria

Inclusion Criteria

  • Patients that
  • are 18 years of age or older
  • 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
  • have given written informed consent

Exclusion Criteria

  • a previously diagnosed invasive mycosis
  • the inability to perform the breathing manoeuvre needed for eNose-analysis of exhaled air

Outcomes

Primary Outcomes

accuracy with which the Cyranose can discriminate between patients with probable or proven invasive pulmonary aspergillosis and neutropenic controls with fever

Time Frame: 4 days

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

Study Sites (1)

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