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

NCT07272915 | Completed

• 1 other identifier: 2024PI143
• Study Type: observational
• Target: 280
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Candidemia; Aspergillosis Invasive; Pneumocystosis; Pneumonia (Etiology); IFI

Keywords

Patients with IFI risks

Outcome Measures

Primary Outcomes (1)

• BDG level

  day 0

Interventions

Beta-1,3/1,6-D-Glucan DIAGNOSTIC_TEST

BDG test Fujifilm Wako

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients at risk of IFI undergoing one or more BDG measurements performed at CHRU Nancy.

You may qualify if:

• BDG test in CHRU Nancy

You may not qualify if:

• other hospitals

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU Nancy

Vandœuvre-lès-Nancy, 54500, France

Location

MeSH Terms

Conditions

Candidemia; Pneumonia, Pneumocystis; Pneumonia

Condition Hierarchy (Ancestors)

Candidiasis, Invasive; Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections; Fungemia; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases, Fungal; Pneumocystis Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PU-PH

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 9, 2025
• Study Start: December 17, 2024
• Primary Completion: June 11, 2025
• Study Completion: June 11, 2025
• Last Updated: December 9, 2025

Record last verified: 2025-12

Locations

FR (1)