Performance Evaluation of the Fujifilm Wako Beta-D-glucan Technique in the Diagnosis of Major Inv… (NCT07272915) | Clinical Trial Compass
CompletedNot Applicable
Performance Evaluation of the Fujifilm Wako Beta-D-glucan Technique in the Diagnosis of Major Invasive Fungal Infections (IFI)
France280 participantsStarted 2024-12-17
Plain-language summary
Invasive fungal infections (IFI) are a major concern for immunocompromised or vulnerable patients. Associated mortality is significant and depends on the timeliness of diagnostic and therapeutic management. Consequently, biomarkers play a key role in therapeutic strategies compared to conventional phenotypic techniques, due to their shorter turnaround time. Beta-D-glucan (BDG) is a pan-fungal serum marker that enables the detection of invasive fungal infections (primarily candidiasis, aspergillosis, and pneumocystosis). This marker was initially introduced by CapeCod, and most studies are based on this test. More recently, the Wako test has been proposed and implemented in our center.
Our study aims to report our experience using the Wako test for BDG measurement, focusing on true and false positives.
The objective is to estimate the test performance, within the patient population, and the percentage of confirmed IFI diagnoses when at least two positive Wako test results are observed in the same patient within a consecutive 15-day period.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* BDG test in CHRU Nancy
Exclusion Criteria:
* other hospitals
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested a blood test called the Fujifilm Wako Beta-D-glucan technique to help diagnose serious fungal infections like Candida in the bloodstream, invasive Aspergillosis, and Pneumocystis pneumonia — is this specific blood test something you currently use or have access to when trying to diagnose these infections in my case?
2Since this study has already been completed, have its results been published yet, and do they suggest that this Beta-D-glucan test is more accurate or reliable than the methods you are currently using to detect invasive fungal infections?
3The trial focused on measuring Beta-D-glucan levels in the blood as a way to spot serious fungal infections earlier — could discussing my own Beta-D-glucan levels be a useful part of my diagnostic workup, and what would a high or borderline result actually mean for my treatment decisions?
4Given that this was a diagnostic accuracy study rather than a treatment trial, how would a more reliable fungal infection test like this one change the speed or approach of my care if I am at risk for one of these infections?
5Are there situations in my specific health situation where a false positive or false negative on a Beta-D-glucan test could be a real concern, and how does my doctor weigh that when deciding whether to start antifungal treatment?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.