Actively Recruiting
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
Led by Bart Rijnders · Updated on 2024-05-07
300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on invasive aspergillosis (IA), a common fungal infection affecting immunocompromised patients with blood-related diseases. The study aims to improve diagnosis by detecting mutations in fungal DNA that cause resistance to azole drugs, which are the main treatments for IA. This is especially important in the Netherlands, where resistance is common and linked to high mortality rates. Participants will have Aspergillus PCR tests performed on different volumes of their serum and plasma. These tests seek to quickly identify azole resistance mutations directly from blood samples, bypassing slower fungal cultures. The study evaluates the performance of two PCR tests, compares different media used in these tests, and determines the optimal PCR cycle threshold within one week. During the study, participants undergo lung CT scans and bronchoalveolar lavage as part of their care. Researchers collect blood samples for PCR testing and assess test performance shortly after. The primary outcomes focus on how well the PCR tests detect resistance mutations. Participants must be adults with specific lung lesions and planned or recent lavage. The study excludes those unable or unwilling to provide consent.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 within 48 hours
You will not qualify if you...
- Patients unable or unwilling to provide consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 week
Participants undergo Aspergillus PCR testing on serum and plasma samples to detect azole resistance mutations.
1 to 2 visits depending on sample collection timing
Duration - Up to 1 week
Participants are observed following PCR testing to assess outcomes related to invasive fungal infection.
Additional assessments may occur depending on clinical status
Trial Site Locations
Total: 1 location
1
Erasmus Medical Center (EMC)
Rotterdam, South Holland, Netherlands, 3000 CA
Actively Recruiting
Research Team
B
Bart Rijnders, MD, PhD
H
Hanne Lamberink, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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