Actively Recruiting

Age: 18Years +
All Genders
ID06069505

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

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

Long-term Monitoring

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

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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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