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NCT Number: NCT06069505

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

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.

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Key information

Conditions

Invasive Aspergillosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Erasmus Medical Center (EMC)

Rotterdam, South Holland, 3000 CA, Netherlands

Location status: Recruiting

Location contact

Bart J Rijnders, MD, PhD

CONTACT

[email protected]

31107033510

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aspergillus PCR

Diagnostic Test

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

Primary outcomes

  1. Performance of two different PCR test

    Time frame: 1 week

    The 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.

  2. Performance of two different media for the PCR test

    Time frame: 1 week

    Extraction medium (serum versus plasma) and extraction volume (1, 3 or 10 ml) that results in best sensitivity and specificity will be determined

  3. Determination of best PCR cycle threshold

    Time frame: 1 week

    Extraction medium (serum versus plasma) and extraction volume (1, 3 or 10 ml) that results in best sensitivity and specificity will be determined

Study contacts

Contact information is provided by the study sponsor or research team.

Bart Rijnders, MD, PhD

CONTACT

[email protected]

+31107033510

Hanne Lamberink, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Bart Rijnders

Other

Registry information

Acronym: ARPO

Important dates

Study start
2017
Primary completion
2030
Study completion
2030
First posted
Oct 5, 2023
Registry last updated
May 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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