Isavuconazole in Critically Ill Patients: A Study on Antifungal Efficacy and Safety
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
- 主要终点
- Radiological Progress in Pulmonary Fungal Infections
研究概览
简要总结
Due to factors such as disease status, gastrointestinal conditions, commonly used medications (e.g., vasopressors), and cardiac output, the plasma concentration of isavuconazole in critically ill patients may differ from that in healthy individuals, exhibiting significant variability.
This study aims to explore the variability of isavuconazole plasma concentrations in critically ill patients and its correlation with efficacy and adverse effects. The research includes:
- The distribution and variability of isavuconazole plasma concentrations in critically ill patients;
- Clinical outcomes;
- Adverse effects.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 critically ill patients (≥18 years) admitted to ICU with suspected or confirmed invasive fungal infection (IFI)
- •IFI diagnosis per EORTC/MSGERC 2019 criteria
排除标准
- •Drug allergy
- •Inherited short QT syndrome
- •Contraindications for nasogastric/oral drug delivery
- •<18 years old
研究组 & 干预措施
Isavuconazole group
Critically ill patients who meet the indicated conditions per the prescribing information, administer isavuconazole as follows: Loading dose: 200 mg every 8 hours (q8h) for three times, Maintenance dose: 200 mg once daily (qd)
干预措施: Isavuconazole treatment (Drug)
结局指标
主要结局
Radiological Progress in Pulmonary Fungal Infections
时间窗: At treatment day 42
A chest CT uses X-ray tomography, where the patient lies on a table while the machine rotates to capture cross-sectional images
Plasma concentration
时间窗: On or after day 7 post-dose
Venous blood samples were collected, centrifuged to obtain supernatant, and concentrations were measured by liquid chromatography-tandem mass spectrometry
Change in immune function profiles (cellular and humoral immunity markers)
时间窗: Enrollment (Baseline) → Treatment Day 42
Specific immune markers (e.g., CD4+/CD8+ counts, immunoglobulin levels, or cytokine profiles) will be selected based on emerging evidence or preliminary data prior to finalizing the statistical analysis plan.
Composite infection biomarker profile (including PCT, CRP, IL-6 and WBC)
时间窗: Enrollment (Baseline) → Treatment Day 42
The assessment of infection progression is conducted through a comprehensive scoring system as follows: Infection Biomarker Score (0-8 points) based on: * PCT \>0.5 ng/mL (2 point) * CRP \>10 mg/L (1 point) * IL-6 \>30 pg/mL (2 point) * WBC \>10×10⁹/L (3 point)
次要结局
- Electrocardiogram QT Interval(On day 10 post-dose)
- Composite liver function outcome (including ALT, AST, bilirubin, ALP, and albumin).(From enrollment (Day 0) through Treatment Day 42)
研究者
Wen-Xiang Cao
Senior Clinical Pharmacist
Shanghai 10th People's Hospital