Isavuconazole in Critically Ill Patients: Efficacy and Safety

Tongji University

Status: Not yet enrolling

Conditions: Fungal Infection; Aspergillosis; Mucormycosis

Treatments: Drug: Isavuconazole treatment

Study type: Observational

Funder types: Other

Identifiers

NCT07080359

SHSY-IEC-6.0/25K114/P01

Details and patient eligibility

About

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

75 participants in 1 patient group

Isavuconazole group

Description:

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)

Treatment:

Drug: Isavuconazole treatment