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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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06069505
Acronym
ARPO
Enrollment
300
Registered
2023-10-05
Start date
2017-07-01
Completion date
2030-12-31
Last updated
2024-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Invasive Aspergillosis

Keywords

invasive aspergillosis, PCR

Brief summary

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_TESTAspergillus PCR

Aspergillus PCR will be performed on different volumes of serum and plasma of patients with hematological malignancies with suspicion for invasive fungal infection.

Sponsors

Bart Rijnders
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Performance of two different PCR test1 weekThe sensitivity and specificity will be determined of the different PCR's tested including the commercially available AsperGenius (Pathonostics, Maastricht) and the in-house PCR. For this purpose a patients diagnosed with proven or probable IPA according to the EORTC/MSG definition will be used as the gold standard.
Performance of two different media for the PCR test1 weekExtraction medium (serum versus plasma) and extraction volume (1, 3 or 10 ml) that results in best sensitivity and specificity will be determined
Determination of best PCR cycle threshold1 weekExtraction medium (serum versus plasma) and extraction volume (1, 3 or 10 ml) that results in best sensitivity and specificity will be determined

Countries

Netherlands

Contacts

Primary ContactBart Rijnders, MD, PhD
b.rijnders@erasmusmc.nl+31107033510
Backup ContactHanne Lamberink, MD
h.lamberink@erasmusmc.nl

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026