The Importance of Non-Conventional Microbiological Methods in the Diagnosis of Candidemia and the Host Cytokine Response to Different Fungal Pathogens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Diagnostic performance of the combined non-conventional testing panel for candidemia
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Age <18 years
- •Insufficient blood sample for additional diagnostic testing
- •Refusal or inability to provide informed consent (if applicable)
研究组 & 干预措施
Non-Conventional Diagnostic Testing Panel
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.
干预措施: Candida Diagnostic Testing Panel (Diagnostic Test)
结局指标
主要结局
Diagnostic performance of the combined non-conventional testing panel for candidemia
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点