Non-Conventional Microbiological Methods in the Diagnosis of Candidemia

NCT07422155 | Completed

• 2 other identifiers: OI-CAND-DIAG-2015-01KME_78_06_14
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Candidemia; Invasive Candidiasis

Keywords

Candida spp.

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  At time of diagnostic work-up during patient hospitalization

Study Arms (1)

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.

Diagnostic Test: Candida Diagnostic Testing Panel

Interventions

Candida Diagnostic Testing Panel DIAGNOSTIC_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.

Non-Conventional Diagnostic Testing Panel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Age \<18 years
• Insufficient blood sample for additional diagnostic testing
• Refusal or inability to provide informed consent (if applicable)

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Candidemia; Candidiasis, Invasive

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections; Fungemia; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 19, 2026
• Study Start: January 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 31, 2018
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)