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 Clinical Trial

— ARPO  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06069505
• Other study ID #: NL62004.078.17
• Secondary ID: MEC-2017-391
• Status: Recruiting
• Start date: July 1, 2017
• Est. completion date: December 31, 2030

Study information

• Verified date: May 2024
• Source: Erasmus Medical Center
• Contact: Bart Rijnders, MD, PhD
• Phone: +31107033510
• Email: b.rijnders[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2030
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aspergillosis
• Invasive Aspergillosis

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Netherlands	Erasmus Medical Center (EMC)	Rotterdam	Zuid Holland

Sponsors (1)

Lead Sponsor	Collaborator
Bart Rijnders

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance of two different PCR test	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.	1 week
Primary	Performance of two different media for the PCR test	Extraction medium (serum versus plasma) and extraction volume (1, 3 or 10 ml) that results in best sensitivity and specificity will be determined	1 week
Primary	Determination of best PCR cycle threshold	Extraction medium (serum versus plasma) and extraction volume (1, 3 or 10 ml) that results in best sensitivity and specificity will be determined	1 week