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

NCT ID: NCT06069505

Last Updated: 2024-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-01

Study Completion Date

2030-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Invasive Aspergillosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bart Rijnders

OTHER

Sponsor Role lead

Responsible Party

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Bart Rijnders

Clinical Professor in Infectious Diseases

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Erasmus Medical Center (EMC)

Rotterdam, South Holland, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Bart Rijnders, MD, PhD

Role: CONTACT

+31107033510

Hanne Lamberink, MD

Role: CONTACT

Facility Contacts

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Bart J Rijnders, MD, PhD

Role: primary

31107033510

Other Identifiers

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MEC-2017-391

Identifier Type: OTHER

Identifier Source: secondary_id

NL62004.078.17

Identifier Type: -

Identifier Source: org_study_id

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