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

NCT ID: NCT07272915

Last Updated: 2025-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

280 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-17

Study Completion Date

2025-06-11

Brief Summary

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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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Detailed Description

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Conditions

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Candidemia Aspergillosis Invasive Pneumocystosis; Pneumonia (Etiology) IFI

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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

BDG test Fujifilm Wako

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* BDG test in CHRU Nancy

Exclusion Criteria

* other hospitals
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Anne DEBOURGOGNE

PU-PH

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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CHRU Nancy

Vandœuvre-lès-Nancy, , France

Site Status

Countries

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France

Other Identifiers

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2024PI143

Identifier Type: -

Identifier Source: org_study_id

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