Detecting azole resistance in invasive aspergillosis patients using blood samples
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
Erasmus Medical Center · NCT06069505
This study is testing a new way to quickly find out if patients with a serious fungal infection have a type that is resistant to common treatments, using blood samples from people with weakened immune systems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Erasmus Medical Center (other) |
| Locations | 1 site (Rotterdam, South Holland) |
| Trial ID | NCT06069505 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on immunocompromised patients suffering from invasive aspergillosis, a serious fungal infection. The researchers aim to optimize a PCR method to detect mutations associated with azole resistance in fungal DNA extracted directly from serum or plasma. By identifying these mutations quickly, the study seeks to enhance the diagnosis and treatment outcomes for patients infected with azole-resistant Aspergillus fumigatus. The study is particularly relevant given the high prevalence of azole resistance in the Netherlands.
Who should consider this trial
Good fit: Ideal candidates for this study are immunocompromised individuals aged 18 and older with lung lesions indicative of possible invasive fungal infection.
Not a fit: Patients who are unable or unwilling to provide consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to faster and more accurate diagnosis of azole resistance, improving treatment outcomes for patients with invasive aspergillosis.
How similar studies have performed: While the approach of detecting azole resistance mutations is critical, this specific methodology has not been widely tested in similar studies, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rotterdam, South Holland
- Erasmus Medical Center (EMC) — Rotterdam, South Holland, Netherlands (RECRUITING)
Study contacts
- Study coordinator: Bart Rijnders, MD, PhD
- Email: b.rijnders@erasmusmc.nl
- Phone: +31107033510
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Invasive Aspergillosis, invasive aspergillosis, PCR