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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isavuconazole treatment | Drug | Administer isavuconazole as follows: Loading dose: 200 mg every 8 hours (q8h) for three times, Maintenance dose: 200 mg once daily (qd) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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. | 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:
| Enrollment (Baseline) → Treatment Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Electrocardiogram QT Interval | A 6-lead ECG was performed. | 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)
|
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Inclusion Criteria:
Exclusion Criteria:
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Adult ICU patients meeting criteria for isavuconazole therapy according to the '2023 Isavuconazole Clinical Expert Consensus'
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wen-Xiang Cao | Contact | +8613062772669 | 731438603@qq.com |
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Data will be made available through Corresponding author's email upon reasonable request to the corresponding author, subject to privacy/ethical restrictions
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Data will be made available through Corresponding author's email upon reasonable request to the corresponding author, subject to privacy/ethical restrictions
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| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001228 | Aspergillosis |
| D009091 | Mucormycosis |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D020096 | Zygomycosis |
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| From enrollment (Day 0) through Treatment Day 42 |