Isavuconazole in Critically Ill Patients: Efficacy and Safety

Isavuconazole in Critically Ill Patients: A Study on Antifungal Efficacy and Safety

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 Overview

• Status: Not yet recruiting
• Conditions: Fungal Infection; Aspergillosis; Mucormycosis
• Intervention / Treatment: Drug: Isavuconazole treatment

• Study Type: Observational
• Enrollment (Estimated): 75

Contacts and Locations

• Study Contact: Name: Wen-Xiang Cao; Phone Number: +8613062772669; Email: 731438603@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult ICU patients meeting criteria for isavuconazole therapy according to the '2023 Isavuconazole Clinical Expert Consensus'

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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)	Drug: Isavuconazole treatment; Administer isavuconazole as follows: Loading dose: 200 mg every 8 hours (q8h) for three times, Maintenance dose: 200 mg once daily (qd)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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: 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)	Enrollment (Baseline) → Treatment Day 42

Secondary Outcome Measures

Outcome Measure	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); ALP >2×ULN (2 points); Albumin <3.0 g/dL (1 point)	From enrollment (Day 0) through Treatment Day 42

Collaborators and Investigators

• Sponsor: Shanghai 10th People's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: June 25, 2025
• First Submitted That Met QC Criteria: July 14, 2025
• First Posted (Actual): July 23, 2025

Study Record Updates

• Last Update Posted (Actual): July 23, 2025
• Last Update Submitted That Met QC Criteria: July 14, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Aspergillosis; Mycoses; Mucormycosis; Zygomycosis; Anti-Infective Agents; Antifungal Agents; Isavuconazole
• Other Study ID Numbers: SHSY-IEC-6.0/25K114/P01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be made available through Corresponding author's email upon reasonable request to the corresponding author, subject to privacy/ethical restrictions
• IPD Sharing Access Criteria: Data will be made available through Corresponding author's email upon reasonable request to the corresponding author, subject to privacy/ethical restrictions
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No