CompletedNot Applicable

Non-Conventional Microbiological Methods in the Diagnosis of Candidemia

Slovenia2 participantsStarted 2015-01

Plain-language 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. 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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) Exclusion Criteria: * Age \<18 years * Insufficient blood sample for additional diagnostic testing * Refusal or inability to provide informed consent (if applicable)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Diagnostic performance of the combined non-conventional testing panel for candidemia

Timeframe: At time of diagnostic work-up (baseline)

Diagnostic performance of the combined non-conventional testing panel for candidemia

Timeframe: At time of diagnostic work-up during patient hospitalization

Trial details

NCT IDNCT07422155

SponsorInstitute of Oncology Ljubljana

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-12

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