Detection of Azole Resistance Inducing Mutations on DNA Extracted Directly From Serum or Plasma of Immunocompromised Patients With an Invasive Aspergillus Infection Azole Resistance PCR Optimalization-study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Aspergillus PCR.
- Who it may be relevant to
- Registry conditions: Invasive Aspergillosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Invasive aspergillosis (IA) is the most common mould infection in immunocompromised patients with haematological disease. 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. The investigators aim to detect azole resistance associated mutations in fungal DNA extracted directly from serum or plasma to accelerate diagnosis and improve outcome of patients infected with azole resistant A. fumigatus.
Interventions
- Diagnostic test Aspergillus PCR
Aspergillus PCR will be performed on different volumes of serum and plasma of patients with hematological malignancies with suspicion for invasive fungal infection.
Primary outcome measures
- Performance of two different PCR test [Time frame: 1 week]
- Performance of two different media for the PCR test [Time frame: 1 week]
- Determination of best PCR cycle threshold [Time frame: 1 week]
Eligibility criteria
Inclusion criteria
- 18 years or older.
- Lung CT shows lesions that fulfil the EORTC/MSG radiological criteria of possible invasive fungal infection.
- A bronchoalveolar lavage is planned or has been performed <48hrs earlier
Exclusion criteria
\- Patients unable or unwilling to provide consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Netherlands · 1 center
- Erasmus Medical Center (EMC) — Rotterdam
Identifiers
NCT: NCT06069505 · NL62004.078.17 · MEC-2017-391