to establish the accuracy with which the eNose can discriminate patients with invasive pulmonary aspergillosis from controls
ID
Source
Brief title
Condition
- Haematological disorders NEC
- Fungal infectious disorders
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To establish the accuracy with which the Cyranose* can discriminate patients
with probable or proven invasive pulmonary aspergillosis from neutropenic
controls with fever.
Secondary outcome
To establish whether neutropenic patients with fever but no sign of
aspergillosis can be discriminated from healthy subjects, thus measuring the
combined influence of chemotherapy, neutropenia, antibiotics and fever on the
algorithm used for the main objective.
Background summary
One of the most difficult forms of pneumonia as to the isolation of the
responsible pathogen is invasive pulmonary mycosis. This is reflected by the
extensive criteria for *possible*, *probable* and *proven* invasive fungal
disease, drafted by the EORTC/MSG. Usually a *probable* infection is considered
enough evidence to *establish diagnosis*, as *proven* disease - for which it is
required to isolate the responsible pathogen from a specimen obtained from a
normally sterile site - is generally only diagnosed post-mortem. In daily
practice this diagnostic inaccuracy is quite a problem. The treatment of
invasive fungal disease takes a long time (at least 6 weeks) and makes use of
antimycotics that can have serious adverse effects, e.g. renal insufficiency,
liver failure and bone marrow suppression. Moreover, an invasive fungal
infection can delay an oncologically important follow-up treatment. It is
therefore clear that more accurate diagnostic methods are highly needed.
In conclusion, the eNose could be a fast, cheap, non-invasive, and
easy-to-perform new tool in the diagnosis of pulmonary invasive mycosis that
could improve diagnostic accuracy and possibly obviate broncho-alveolar lavage.
It can be incorporated in a pre-emptive strategy and in this way hopefully
reduce the mortality of the infectious complications associated with the
treatment of haematological diseases.
Study objective
to establish the accuracy with which the eNose can discriminate patients
with invasive pulmonary aspergillosis from controls
Study design
All patients will be managed identically and according to local protocol with
respect to the prevention, diagnosis and treatment of mycoses. Except for
analysis of exhaled air using the eNose every prophylactic, diagnostic and
treatment-related procedure is considered to be standard care.
Study burden and risks
Analysis of exhaled air is non-invasive, easy and not associated with any
complications or toxicity. The measurement will take 10 minutes. During this
period the patient has to breathe through a device. Except for analysis of
exhaled air using the eNose, patients included in this trial will not undergo
any prophylactic, diagnostic or treatment-related procedure for the purposes of
this study other than standard care.
Meibergdreef 9
1105 AZ
NL
Meibergdreef 9
1105 AZ
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL29180.018.09 |