- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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 (ARPO)
October 5, 2023 updated by: Bart Rijnders
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Bart Rijnders, MD, PhD
- Phone Number: +31107033510
- Email: b.rijnders@erasmusmc.nl
Study Contact Backup
- Name: Hanne Lamberink, MD
- Email: h.lamberink@erasmusmc.nl
Study Locations
-
-
Zuid Holland
-
Rotterdam, Zuid Holland, Netherlands, 3000 CA
- Recruiting
- Erasmus Medical Center (EMC)
-
Contact:
- Bart J Rijnders, MD, PhD
- Phone Number: 31107033510
- Email: b.rijnders@erasmusmc.nl
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
100 haematology patients with a radiologically suspected invasive pulmonary aspergillosis and undergoing a bronchoalveolar lavage.
After the BAL diagnostic tests have become available, confirmation of the suspected infection is expected in 25 patients and therefore 25 evaluable patients will remain.
The investigators decided that another 50 patients should be included because only 25% had an invasive fungal infection after interim analysis of the first 50 patients included.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 week
|
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
|
1 week
|
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
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 15, 2017
Primary Completion (Estimated)
December 31, 2023
Study Completion (Estimated)
December 31, 2023
Study Registration Dates
First Submitted
October 2, 2023
First Submitted That Met QC Criteria
October 2, 2023
First Posted (Actual)
October 5, 2023
Study Record Updates
Last Update Posted (Actual)
October 6, 2023
Last Update Submitted That Met QC Criteria
October 5, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL62004.078.17
- MEC-2017-391 (Other Identifier: METC Erasmus Medical Center)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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