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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06069505
Other study ID # NL62004.078.17
Secondary ID MEC-2017-391
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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
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