Isavuconazole in Critically Ill Patients: Efficacy and Safety
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShanghai 10th People's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult critically ill patients (≥18 years) admitted to ICU with suspected or confirmed invasive fungal infection (IFI)
IFI diagnosis per EORTC/MSGERC 2019 criteria
Disqualifiers
Drug allergy
Inherited short QT syndrome
Contraindications for nasogastric/oral drug delivery
<18 years old
Trial population
Adult ICU patients meeting criteria for isavuconazole therapy according to the '2023 Isavuconazole Clinical Expert Consensus'
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Isavuconazole treatment
DrugAdminister isavuconazole as follows: Loading dose: 200 mg every 8 hours (q8h) for three times, Maintenance dose: 200 mg once daily (qd)
Treatment groups
75 Participants
are divided into 1 treatment groupGroup A: Isavuconazole group1 intervention
Trial outcomes
Primary outcomes
1
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 422
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-dose3
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 424
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 42Secondary outcomes
1
Electrocardiogram QT Interval
A 6-lead ECG was performed.
Time frame
On day 10 post-dose2
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 42Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: