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Not yet recruiting NCT07080359

Isavuconazole in Critically Ill Patients: Efficacy and Safety

— Observational Fungal Infection Aspergillosis Mucormycosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Isavuconazole treatment.
Who it may be relevant to
Registry conditions: Fungal Infection, Aspergillosis, Mucormycosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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)

Primary outcome measures

  • Radiological Progress in Pulmonary Fungal Infections [Time frame: At treatment day 42]
  • Plasma concentration [Time frame: On or after day 7 post-dose]
  • Change in immune function profiles (cellular and humoral immunity markers) [Time frame: Enrollment (Baseline) → Treatment Day 42]
  • Composite infection biomarker profile (including PCT, CRP, IL-6 and WBC) [Time frame: Enrollment (Baseline) → Treatment Day 42]
Secondary outcome measures (2)
  • Electrocardiogram QT Interval [Time frame: On day 10 post-dose]
  • Composite liver function outcome (including ALT, AST, bilirubin, ALP, and albumin). [Time frame: From enrollment (Day 0) through Treatment Day 42]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07080359 · SHSY-IEC-6.0/25K114/P01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗