ARPO: 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

Sponsor

Bart Rijnders (Other)

Overall Status

Recruiting

CT.gov ID

NCT06069505

Collaborator

(none)

100

Enrollment

Location

77.5

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Invasive Aspergillosis	Diagnostic Test: Aspergillus PCR

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Jul 15, 2017

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Outcome Measures

Primary Outcome Measures

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.
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Erasmus Medical Center (EMC)	Rotterdam	Zuid Holland	Netherlands	3000 CA

Sponsors and Collaborators

Bart Rijnders

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bart Rijnders, Clinical Professor in Infectious Diseases, Erasmus Medical Center

ClinicalTrials.gov Identifier:

NCT06069505

Other Study ID Numbers:

NL62004.078.17
MEC-2017-391

First Posted:

Oct 5, 2023

Last Update Posted:

Oct 6, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Bart Rijnders, Clinical Professor in Infectious Diseases, Erasmus Medical Center

invasive aspergillosis

PCR

Additional relevant MeSH terms:

Aspergillosis

Study Results

No Results Posted as of Oct 6, 2023