CandidemiaNCT07272915
Performance Evaluation of the Fujifilm Wako Beta-D-glucan Technique in the Diagnosis of Major Invasive Fungal Infections (IFI)
An observational study of Candidemia and Aspergillosis Invasive, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Candidemia, Aspergillosis Invasive, Pneumocystosis; Pneumonia (Etiology)
- What is being tested?
- Beta-1,3/1,6-D-Glucan
- How many people
- 280 participants
- Where
- 1 siteFrance
- Study dates
- 17 Dec 2024to 11 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients at risk of IFI undergoing one or more BDG measurements performed at CHRU Nancy.
Who may be able to join
- BDG test in CHRU Nancy
Who cannot join
- other hospitals
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Performance Evaluation of the Fujifilm Wako Beta-D-glucan Technique and the Number of Determinations in the Diagnosis of Major Invasive Fungal Infections (IFI)
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.
- Being tested
- Beta-1,3/1,6-D-Glucan
- Keywords
- Patients with IFI risks
- Medical subject headings
- Candidemia, Pneumonia, Pneumocystis, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta-1,3/1,6-D-GlucanDiagnostic test
BDG test Fujifilm Wako
What is being measured
The primary outcome is the main question the study is designed to answer.
BDG level
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start17 Dec 2024
- Primary completion11 Jun 2025
- Study completion11 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CandidemiaStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne DEBOURGOGNE, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07272915
- Sponsor's protocol ID
- 2024PI143
- Status last verified
- Dec 2025
- First submitted
- 26 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Evaluation of the Fujifilm Wako Beta-D-glucan Technique and the Number of Determinations in the Diagnosis of Major Invasive Fungal Infections (IFI)
- ClinicalTrials.gov ID
- NCT07272915
- Acronym / sponsor ID
- 2024PI143
- Keywords
- Patients with IFI risks
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 17 Dec 2024 (actual)
- Primary completion
- 11 Jun 2025 (actual)
- Study completion
- 11 Jun 2025 (actual)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients at risk of IFI undergoing one or more BDG measurements performed at CHRU Nancy.
Key inclusion criteria (1 listed)
- BDG test in CHRU Nancy
Key exclusion criteria (1 listed)
- other hospitals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beta-1,3/1,6-D-GlucanBDG test Fujifilm Wako | Diagnostic test | – |
Primary outcome
BDG level
Time frame: day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Candidemia and Aspergillosis Invasive, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BDG level (time frame: day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.