Aspergillosis, Fungal Infection, Mucormycosis
Conditions
Brief summary
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.
Interventions
DRUGIsavuconazole treatment
Administer isavuconazole as follows: Loading dose: 200 mg every 8 hours (q8h) for three times, Maintenance dose: 200 mg once daily (qd)
Sponsors
Shanghai 10th People's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult critically ill patients (≥18 years) admitted to ICU with suspected or confirmed invasive fungal infection (IFI) * IFI diagnosis per EORTC/MSGERC 2019 criteria
Exclusion criteria
* Drug allergy * Inherited short QT syndrome * Contraindications for nasogastric/oral drug delivery * \<18 years old
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiological Progress in Pulmonary Fungal Infections | 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 | 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) | 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) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Electrocardiogram QT Interval | On day 10 post-dose | A 6-lead ECG was performed. |
| Composite liver function outcome (including ALT, AST, bilirubin, ALP, and albumin). | From enrollment (Day 0) through Treatment Day 42 | 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) |
Contacts
Primary ContactWen-Xiang Cao
Outcome results
None listed