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

Recruiting

• Conditions: Invasive Aspergillosis

• Registration Number: NCT06069505
• Lead Sponsor: Bart Rijnders

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-01
• Study First Submitted: 2023-10-02
• Study First Submitted QC: 2023-10-02
• Study First Posted: 2023-10-05
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-07
• Primary Completion: 2030-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determination of best PCR cycle threshold	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
Performance of two different media for the PCR test	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
Performance of two different PCR test	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.

Trial Locations

Locations (1)

Erasmus Medical Center (EMC); 🇳🇱 Rotterdam, Zuid Holland, Netherlands