Isavuconazole in Critically Ill Patients: Efficacy and Safety

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-01

Study Completion Date

2030-12-31

Brief Summary

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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:

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

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Detailed Description

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Conditions

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Fungal Infection Aspergillosis Mucormycosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

Isavuconazole treatment

Intervention Type DRUG

Administer isavuconazole as follows: Loading dose: 200 mg every 8 hours (q8h) for three times, Maintenance dose: 200 mg once daily (qd)

Interventions

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Isavuconazole treatment

Administer isavuconazole as follows: Loading dose: 200 mg every 8 hours (q8h) for three times, Maintenance dose: 200 mg once daily (qd)

Intervention Type DRUG

Eligibility Criteria

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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