Performance Evaluation of the Fujifilm Wako Beta-D-glucan Technique in the Diagnosis of Major Invasive Fungal Infections (IFI)

NCT07272915 — Completed, 280 participants, Central Hospital, Nancy, France

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Performance Evaluation of the Fujifilm Wako Beta-D-glucan Technique and the Number of Determinations in the Diagnosis of Major Invasive Fungal Infections (IFI)

Registry	NCT07272915
Status	Completed
Study type	Observational
Enrollment	280 (Actual)
Sponsor	Central Hospital, Nancy, France (Other)
Conditions	Candidemia, Aspergillosis Invasive, Pneumocystosis; Pneumonia (Etiology), IFI
Interventions	Beta-1,3/1,6-D-Glucan (Diagnostic test)
Dates	start 2024-12-17, primary completion 2025-06-11, completion 2025-06-11, first posted 2025-12-09, last updated 2025-12-09
Locations	1 site in France

-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.

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+Arms and interventions

Beta-1,3/1,6-D-Glucan (Diagnostic test): BDG test Fujifilm Wako

+Outcome measures

Primary outcomes

BDG level [day 0]

+Eligibility

Sex: All

Inclusion Criteria:

* BDG test in CHRU Nancy

Exclusion Criteria:

* other hospitals

+Locations (1)

Facility	City	Country	Status
CHRU Nancy	Vandœuvre-lès-Nancy	France