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

NCT07272915 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 280

Last updated 2025-12-09

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

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

BDG test Fujifilm Wako

Sponsors & Collaborators

  • Central Hospital, Nancy, France

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-17
Primary Completion
2025-06-11
Completion
2025-06-11

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07272915 on ClinicalTrials.gov