CandidemiaNCT07422155
Non-Conventional Microbiological Methods in the Diagnosis of Candidemia
A study testing Candida Diagnostic Testing Panel in people with Candidemia and Invasive Candidiasis, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
Trial summary
This study evaluates the diagnostic value of non-conventional microbiological methods for early detection of candidemia and invasive candidiasis in adult hospitalized patients with suspected invasive fungal infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Candidemia, Invasive Candidiasis
- What is being tested?
- Candida Diagnostic Testing Panel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteSlovenia
- Study dates
- Jan 2015to 31 Dec 2018
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult hospitalized patients (≥18 years)
- Clinical suspicion of invasive/systemic fungal infection (suspected fungal sepsis)
- Presence of risk factors for invasive fungal disease (e.g., ICU admission, central/peripheral venous catheters, parenteral nutrition, broad-spectrum antibiotic therapy >3 days, corticosteroid therapy, chemotherapy, immunosuppression, neutropenia, hemodialysis, mechanical ventilation, or Candida colonization)
Who cannot join
- Age <18 years
- Insufficient blood sample for additional diagnostic testing
- Refusal or inability to provide informed consent (if applicable)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Importance of Non-Conventional Microbiological Methods in the Diagnosis of Candidemia and the Host Cytokine Response to Different Fungal Pathogens
This study evaluates the diagnostic value of non-conventional microbiological methods for early detection of candidemia and invasive candidiasis in adult hospitalized patients with suspected invasive fungal infection. Conventional blood culture remains the gold standard for diagnosis but has limited sensitivity and may delay initiation of targeted antifungal therapy.
The study investigates whether the combined use of serum biomarkers (1,3)-β-D-glucan, mannan and anti-mannan antibodies, and molecular detection of Candida DNA by PCR improves the diagnostic performance compared with conventional culture-based methods.
In addition, the study explores the host cytokine response associated with different Candida species and other fungal pathogens. The goal is to support the development of an optimized diagnostic algorithm for invasive fungal disease and improve clinical management of critically ill patients.
Read the detailed description
Early diagnosis of invasive fungal infections, particularly candidemia and invasive candidiasis, is essential for timely initiation of appropriate antifungal therapy and improvement of patient outcomes. Despite being considered the current diagnostic gold standard, blood culture has limited sensitivity and may remain negative in a substantial proportion of patients with invasive candidiasis. In addition, culture-based identification of fungal pathogens is time-consuming and may delay targeted treatment decisions.
To address these limitations, alternative diagnostic approaches have been developed, including detection of fungal cell wall biomarkers and molecular assays. Serum biomarkers such as (1,3)-β-D-glucan, mannan antigen, and anti-mannan antibodies may provide earlier indication of invasive Candida infection compared with blood culture. Molecular detection of Candida DNA by polymerase chain reaction (PCR) may also offer higher sensitivity and faster turnaround time.
This interventional diagnostic study evaluates the clinical and diagnostic utility of a combined non-conventional microbiological testing panel in adult patients with clinical suspicion of invasive/systemic fungal infection and risk factors for invasive fungal disease (e.g., ICU admission, central venous catheters, broad-spectrum antibiotics, parenteral nutrition, corticosteroid therapy, chemotherapy, immunosuppression, neutropenia, hemodialysis, mechanical ventilation, and Candida colonization).
Participants undergo routine blood culture testing for bacteria and fungi as part of standard clinical care. In addition, blood samples are collected for the following diagnostic tests:
Serum (1,3)-β-D-glucan
Mannan antigen and anti-mannan antibodies
PCR-based detection of Candida DNA from EDTA whole blood
Samples are processed according to routine laboratory procedures in participating microbiology laboratories. Blood culture-positive Candida isolates are identified and stored for further analyses. Participants are categorized into study groups based on blood culture results (Candida-positive blood culture group, bacterial-positive blood culture group, and blood culture-negative group). A healthy volunteer control group may be included for comparative purposes.
The primary objective is to determine whether the combined non-conventional diagnostic panel improves detection of candidemia/invasive candidiasis compared with conventional blood culture alone. Secondary objectives include evaluation of the diagnostic performance of individual biomarkers and PCR testing, assessment of the time to diagnosis, and analysis of host cytokine response patterns associated with different fungal pathogens.
The overall aim of the study is to support the development of an optimized diagnostic algorithm for invasive fungal disease, improve early detection, and reduce unnecessary or delayed antifungal treatment in critically ill patients.
- Conditions
- Candidemia, Invasive Candidiasis
- Being tested
- Candida Diagnostic Testing Panel
- Keywords
- Candida spp.
- Medical subject headings
- Candidemia, Candidiasis, Invasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Candida Diagnostic Testing PanelDiagnostic test
Participants underwent routine blood culture testing for bacteria and fungi and additional non-conventional diagnostic testing for suspected invasive candidiasis, including serum (1,3)-beta-D-glucan, mannan antigen, anti-mannan antibodies, and PCR-based detection of Candida DNA from EDTA whole blood samples. The combined diagnostic panel was used to assess its potential value for earlier and improved detection of candidemia compared with conventional culture-based methods.
| Study group | Role | What they receive |
|---|---|---|
| Non-Conventional Diagnostic Testing Panel | Experimental | Adult hospitalized patients with suspected invasive fungal infection underwent routine blood culture testing and additional non-conventional diagnostic testing including serum (1,3)-β-D-glucan, mannan/anti-mannan antibodies, and PCR-based detection of Candida DNA in blood samples, in order to evaluate the diagnostic utility of combined microbiological methods for early detection of candidemia. Receives: Diagnostic Test: Candida Diagnostic Testing Panel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of the combined non-conventional testing panel for candidemia
Sensitivity and specificity of the combined diagnostic panel (blood culture, Candida PCR, (1,3)-beta-D-glucan, mannan and anti-mannan antibodies) for detection of candidemia and invasive candidiasis in adult hospitalized patients with suspected invasive fungal infection.
Measured: At time of diagnostic work-up (baseline)
Diagnostic performance of the combined non-conventional testing panel for candidemia
Sensitivity and specificity of the combined diagnostic panel (blood culture, Candida PCR, (1,3)-beta-D-glucan, mannan and anti-mannan antibodies) for detection of candidemia and invasive candidiasis in adult hospitalized patients with suspected invasive fungal infection.
Measured: At time of diagnostic work-up during patient hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study startJan 2015
- Primary completionDec 2018
- Study completion31 Dec 2018
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants undergo routine blood culture testing and additional non-conventional diagnostic testing (β-D-glucan, mannan/anti-mannan, Candida PCR). Groups are defined based on blood culture results.
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Oncology Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07422155
- Sponsor's protocol ID
- OI-CAND-DIAG-2015-01
- Other IDs
- KME_78_06_14
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Importance of Non-Conventional Microbiological Methods in the Diagnosis of Candidemia and the Host Cytokine Response to Different Fungal Pathogens
- ClinicalTrials.gov ID
- NCT07422155
- Acronym / sponsor ID
- OI-CAND-DIAG-2015-01
- Conditions
- Candidemia, Invasive Candidiasis
- Keywords
- Candida spp.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 19 Feb 2026 (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.
This study evaluates the diagnostic value of non-conventional microbiological methods for early detection of candidemia and invasive candidiasis in adult hospitalized patients with suspected invasive fungal infection. Conventional blood culture remains the gold standard for diagnosis but has limited sensitivity and may delay initiation of targeted antifungal therapy.
The study investigates whether the combined use of serum biomarkers (1,3)-β-D-glucan, mannan and anti-mannan antibodies, and molecular detection of Candida DNA by PCR improves the diagnostic performance compared with conventional culture-based methods.
In addition, the study explores the host cytokine response associated with different Candida species and other fungal pathogens. The goal is to support the development of an optimized diagnostic algorithm for invasive fungal disease and improve clinical management of critically ill patients.
Detailed description
Early diagnosis of invasive fungal infections, particularly candidemia and invasive candidiasis, is essential for timely initiation of appropriate antifungal therapy and improvement of patient outcomes. Despite being considered the current diagnostic gold standard, blood culture has limited sensitivity and may remain negative in a substantial proportion of patients with invasive candidiasis. In addition, culture-based identification of fungal pathogens is time-consuming and may delay targeted treatment decisions.
To address these limitations, alternative diagnostic approaches have been developed, including detection of fungal cell wall biomarkers and molecular assays. Serum biomarkers such as (1,3)-β-D-glucan, mannan antigen, and anti-mannan antibodies may provide earlier indication of invasive Candida infection compared with blood culture. Molecular detection of Candida DNA by polymerase chain reaction (PCR) may also offer higher sensitivity and faster turnaround time.
This interventional diagnostic study evaluates the clinical and diagnostic utility of a combined non-conventional microbiological testing panel in adult patients with clinical suspicion of invasive/systemic fungal infection and risk factors for invasive fungal disease (e.g., ICU admission, central venous catheters, broad-spectrum antibiotics, parenteral nutrition, corticosteroid therapy, chemotherapy, immunosuppression, neutropenia, hemodialysis, mechanical ventilation, and Candida colonization).
Participants undergo routine blood culture testing for bacteria and fungi as part of standard clinical care. In addition, blood samples are collected for the following diagnostic tests:
Serum (1,3)-β-D-glucan
Mannan antigen and anti-mannan antibodies
PCR-based detection of Candida DNA from EDTA whole blood
Samples are processed according to routine laboratory procedures in participating microbiology laboratories. Blood culture-positive Candida isolates are identified and stored for further analyses. Participants are categorized into study groups based on blood culture results (Candida-positive blood culture group, bacterial-positive blood culture group, and blood culture-negative group). A healthy volunteer control group may be included for comparative purposes.
The primary objective is to determine whether the combined non-conventional diagnostic panel improves detection of candidemia/invasive candidiasis compared with conventional blood culture alone. Secondary objectives include evaluation of the diagnostic performance of individual biomarkers and PCR testing, assessment of the time to diagnosis, and analysis of host cytokine response patterns associated with different fungal pathogens.
The overall aim of the study is to support the development of an optimized diagnostic algorithm for invasive fungal disease, improve early detection, and reduce unnecessary or delayed antifungal treatment in critically ill patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants undergo routine blood culture testing and additional non-conventional diagnostic testing (β-D-glucan, mannan/anti-mannan, Candida PCR). Groups are defined based on blood culture results.
| Arm | Type | Receives |
|---|---|---|
| Non-Conventional Diagnostic Testing Panel | Experimental | Diagnostic Test: Candida Diagnostic Testing PanelAdult hospitalized patients with suspected invasive fungal infection underwent routine blood culture testing and additional non-conventional diagnostic testing including serum (1,3)-β-D-glucan, mannan/anti-mannan antibodies, and PCR-based detection of Candida DNA in blood samples, in order to evaluate the diagnostic utility of combined microbiological methods for early detection of candidemia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult hospitalized patients (≥18 years)
- Clinical suspicion of invasive/systemic fungal infection (suspected fungal sepsis)
- Presence of risk factors for invasive fungal disease (e.g., ICU admission, central/peripheral venous catheters, parenteral nutrition, broad-spectrum antibiotic therapy >3 days, corticosteroid therapy, chemotherapy, immunosuppression, neutropenia, hemodialysis, mechanical ventilation, or Candida colonization)
Key exclusion criteria (3 listed)
- Age <18 years
- Insufficient blood sample for additional diagnostic testing
- Refusal or inability to provide informed consent (if applicable)
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 |
|---|---|---|
| Candida Diagnostic Testing PanelParticipants underwent routine blood culture testing for bacteria and fungi and additional non-conventional diagnostic testing for suspected invasive candidiasis, including serum (1,3)-beta-D-glucan, mannan antigen, anti-mannan antibodies, and PCR-based detection of Candida DNA from EDTA whole blood samples. The combined diagnostic panel was used to assess its potential value for earlier and improved detection of candidemia compared with conventional culture-based methods. | Diagnostic test | Non-Conventional Diagnostic Testing Panel |
Primary outcome
Diagnostic performance of the combined non-conventional testing panel for candidemia
Time frame: At time of diagnostic work-up (baseline)
Sensitivity and specificity of the combined diagnostic panel (blood culture, Candida PCR, (1,3)-beta-D-glucan, mannan and anti-mannan antibodies) for detection of candidemia and invasive candidiasis in adult hospitalized patients with suspected invasive fungal infection.
Diagnostic performance of the combined non-conventional testing panel for candidemia
Time frame: At time of diagnostic work-up during patient hospitalization
Sensitivity and specificity of the combined diagnostic panel (blood culture, Candida PCR, (1,3)-beta-D-glucan, mannan and anti-mannan antibodies) for detection of candidemia and invasive candidiasis in adult hospitalized patients with suspected invasive fungal infection.
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 19 Feb 2026.
- Individual participant dataSharing planned: No
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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?
A study testing Candida Diagnostic Testing Panel in people with Candidemia and Invasive Candidiasis, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
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 3 inclusion and 3 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 19 Feb 2026. 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 Slovenia. 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?
Diagnostic performance of the combined non-conventional testing panel for candidemia (time frame: At time of diagnostic work-up (baseline)). The study lists 2 primary outcomes in all. 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 19 Feb 2026.