Isavuconazole in Critically Ill Patients: Efficacy and Safety

July 14, 2025 updated by: Wen-Xiang Cao, Shanghai 10th People's Hospital

Isavuconazole in Critically Ill Patients: A Study on Antifungal 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult ICU patients meeting criteria for isavuconazole therapy according to the '2023 Isavuconazole Clinical Expert Consensus'

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
At treatment day 42
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
On or after day 7 post-dose
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.
Enrollment (Baseline) → Treatment Day 42
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)
Enrollment (Baseline) → Treatment Day 42

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Electrocardiogram QT Interval
Time Frame: On day 10 post-dose
A 6-lead ECG was performed.
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

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)
From enrollment (Day 0) through Treatment Day 42

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai 10th People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 25, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 23, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SHSY-IEC-6.0/25K114/P01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be made available through Corresponding author's email upon reasonable request to the corresponding author, subject to privacy/ethical restrictions

IPD Sharing Access Criteria

Data will be made available through Corresponding author's email upon reasonable request to the corresponding author, subject to privacy/ethical restrictions

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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