1. Optimise the DNA extraction process on serum and plasma to increase the sensitivity of DNA-based fungal infection diagnostic test (especially genetic mutations conferring azole resistance in invasive aspergillosis). 2. Evaluate new targeted as…
ID
Source
Brief title
Condition
- Leukaemias
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
All patients will be classified as proven, probable or possible, undetermined
or no invasive pulmonary fungal infection according to the EORTC/MSG criteria.
From the patients with probable or proven invasive aspergillosis, the number
and percentages of patients samples producing a result by two different PCRs.
Secondary outcome
Not applicable
Background summary
Invasive aspergillosis (IA) is the most common mould infection in
immunocompromised patients with haematological disease, but in up to 20% of the
patients other fungi like Mucorales, Fusarium or Pneumocystis cause invasive
fungal disease (IFD). Voriconazole, a triazole, improves overall survival of
patients with an IA and is the mainstay of therapy. Resistance of A. Fumigatus
emerged as an important clinical problem and infections with azole resistant
Aspergillus have a high mortality. Nowhere in the world, azole resistance is
more prevalent than in the Netherlands. Rapid detection of resistance is key to
improve the patient's outcome but fungal cultures take time and are often
negative. We aim to improve the detection of Aspergillus as well as other
moulds on serum, plasma and urine. Specifically for Aspergillus fumigatus, we
aim to improve the possibility to test for azole resistance associated
mutations on fungal DNA extracted directly from serum, plasma and urine.
Eventually we hope that by improving the non-invasive diagnostic tests (1)
fewer patients will need to undergo invasive diagnostic tests (e.g.
bronchoscopy, lung biopsy) and (2) we can accelerate the diagnostic pathway and
the outcome in patients with a suspected fungal infection.
Study objective
1. Optimise the DNA extraction process on serum and plasma to increase the
sensitivity of DNA-based fungal infection diagnostic test (especially genetic
mutations conferring azole resistance in invasive aspergillosis).
2. Evaluate new targeted as well as metagenomic shotgun DNA sequencing-based
tests able to detect a broad range of fungi.
Study design
A prospective pilot study. Blood and urine samples from immunocompromised
hematology patients with a suspected pulmonary invasive fungal infection will
be obtained and processed following informed consent.
Study burden and risks
Blood sample collection can cause mild discomfort such as dizziness, pain,
redness or a small bruise at the puncture site. Rarely this can cause an
infection. Collection of urine samples will not lead to a burden or risk for
the patients.
`s Gravendijkwal 230
Rotterdam 3000CA
NL
`s Gravendijkwal 230
Rotterdam 3000CA
NL
Listed location countries
Age
Inclusion criteria
*18 years or older
*Lung CT showes lesions that fullfill the EORTC/MSG radiological criterium of
possible invasive fungal infection.
*A bronchoalveolar lavage is planned or has been performed <48hrs earlier
Exclusion criteria
* Unable or unwilling to provide informed consent
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 | NL62004.078.17 |