NCT07080359

Isavuconazole in Critically Ill Patients: Efficacy and Safety

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 75 (estimated)
• Sponsor: Shanghai 10th People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Fungal Infection
• Aspergillosis
• Mucormycosis

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2025-08-01
• Primary completion: 2029-12-31
• Completion: 2030-12-31
• First posted: 2025-07-23
• Last updated: 2025-07-23