Isavuconazole in Critically Ill Patients: Efficacy and Safety

NCT07080359 | Not Yet Recruiting DMC

• 1 other identifier: SHSY-IEC-6.0/25K114/P01
• Study Type: observational
• Target: 75
• Locations: 0 countries
• Sites: N/A

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. 1.The distribution and variability of isavuconazole plasma concentrations in critically ill patients;
2. 2.Clinical outcomes;
3. 3.Adverse effects.

Conditions

Fungal Infection; Aspergillosis; Mucormycosis

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Electrocardiogram QT Interval

  On day 10 post-dose

• Composite liver function outcome (including ALT, AST, bilirubin, ALP, and albumin).

  From enrollment (Day 0) through Treatment Day 42

Study Arms (1)

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

Interventions

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)

Isavuconazole group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Adult critically ill patients (≥18 years) admitted to ICU with suspected or confirmed invasive fungal infection (IFI)
• IFI diagnosis per EORTC/MSGERC 2019 criteria

You may not qualify if:

• Drug allergy
• Inherited short QT syndrome
• Contraindications for nasogastric/oral drug delivery
• \<18 years old

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

MeSH Terms

Conditions

Mycoses; Aspergillosis; Mucormycosis

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Zygomycosis

Central Study Contacts

Wen-Xiang Cao

CONTACT

+8613062772669; 731438603@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Clinical Pharmacist

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 23, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: July 23, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: Data will be made available through Corresponding author's email upon reasonable request to the corresponding author, subject to privacy/ethical restrictions