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NCT Number: NCT07080359

Isavuconazole in Critically Ill Patients: 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.

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Key information

Conditions

Fungal Infection Aspergillosis Bacterial Infections and Mycoses Infections Mucormycosis Mycoses Zygomycosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. Radiological Progress in Pulmonary Fungal Infections

    Time frame: 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

  2. Plasma concentration

    Time frame: 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

  3. Change in immune function profiles (cellular and humoral immunity markers)

    Time frame: 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.

  4. Composite infection biomarker profile (including PCT, CRP, IL-6 and WBC)

    Time frame: 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 outcomes

  1. Electrocardiogram QT Interval

    Time frame: On day 10 post-dose

    A 6-lead ECG was performed.

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

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Wen-Xiang Cao

CONTACT

[email protected]

+8613062772669

Sponsors and collaborators

Lead sponsor

Shanghai 10th People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
Jul 23, 2025
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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