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: 1. The distribution and variability of isavuconazole plasma concentrations in critically ill patients; 2. Clinical outcomes; 3. Adverse effects.
Study Type
OBSERVATIONAL
Enrollment
75
Administer isavuconazole as follows: Loading dose: 200 mg every 8 hours (q8h) for three times, Maintenance dose: 200 mg once daily (qd)
Radiological Progress in Pulmonary Fungal Infections
A chest CT uses X-ray tomography, where the patient lies on a table while the machine rotates to capture cross-sectional images
Time frame: At treatment day 42
Plasma concentration
Venous blood samples were collected, centrifuged to obtain supernatant, and concentrations were measured by liquid chromatography-tandem mass spectrometry
Time frame: On or after day 7 post-dose
Change in immune function profiles (cellular and humoral immunity markers)
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.
Time frame: Enrollment (Baseline) → Treatment Day 42
Composite infection biomarker profile (including PCT, CRP, IL-6 and WBC)
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)
Time frame: Enrollment (Baseline) → Treatment Day 42
Electrocardiogram QT Interval
A 6-lead ECG was performed.
Time frame: On day 10 post-dose
Composite liver function outcome (including ALT, AST, bilirubin, ALP, and albumin).
Hepatic function will be assessed using a composite scoring system (0-10 points) incorporating: ALT elevation \>3×ULN (2 points) AST elevation \>3×ULN (2 points) Total bilirubin \>2×ULN (3 points) * ALP \>2×ULN (2 points) * Albumin \<3.0 g/dL (1 point)
Time frame: From enrollment (Day 0) through Treatment Day 42
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